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R Garry

Publications and source records attributed to R Garry.

At least 19 recordsLinked to original sources
PubMed2006

Surgical approach to hysterectomy for benign gynaecological disease.

BACKGROUND: There are three approaches to hysterectomy for benign disease - abdominal hysterectomy (AH), vaginal hysterectomy (VH) and laparoscopic hysterectomy (LH). Laparoscopic hysterectomy has three further subdivisions - laparoscopic assisted vaginal hysterectomy (LAVH) where a vaginal hysterectomy is assisted by laparoscopic procedures that do not include uterine artery ligation, laparoscopic hysterectomy (which we will abbreviate to LH(a)) where the laparoscopic procedures include uterine artery ligation, and total laparoscopic hysterectomy (TLH) where there is no vaginal component and the vaginal vault is sutured laparoscopically. OBJECTIVES: To assess the most appropriate surgical approach to hysterectomy. SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders & Subfertility Group's Specialised Register of controlled trials (searched 23 March 2004), CENTRAL (The Cochrane Library Issue 1, 2004), MEDLINE (1966 to Mar 2004), EMBASE (1985 to Mar 2004), Biological Abstracts (1968 to Mar 2004), the National Research Register and relevant citation lists. SELECTION CRITERIA: Only randomised trials comparing one surgical approach to hysterectomy with another were included. DATA COLLECTION AND ANALYSIS: Twenty-seven trials that included 3643 participants were included. Independent selection of trials and data extraction were employed following Cochrane guidelines. MAIN RESULTS: The benefits of VH versus AH were shorter duration of hospital stay (WMD 1.0 day, 95%CI 0.7 to 1.2 days), speedier return to normal activities (WMD 9.5 days, 95%CI 6.4 to 12.6 days), fewer unspecified infections or febrile episodes (OR 0.42, 95%CI 0.21 to 0.83). The benefits of LH versus AH were lower intraoperative bloodloss (WMD 45.3 mls, 95%CI 17.9 to 72.7 mls) and a smaller drop in haemoglobin level (WMD 0.55g/L, 95%CI 0.28 to 0.82g/L), shorter duration of hospital stay (WMD 2.0 days, 95%CI 1.9 to 2.2 days), speedier return to normal activities (WMD 13.6 days, 95%CI 11.8 to 15.4 days), fewer wound or abdominal wall infections (OR 0.32, 95%CI 0.12 to 0.85), fewer unspecified infections or febrile episodes (OR 0.65, 95%CI 0.49 to 0.87), at the cost of longer operating time (WMD 10.6 minutes, 95%CI 7.4 to 13.8 minutes) and more urinary tract (bladder or ureter) injuries (OR 2.61, 95%CI 1.22 to 5.60). There was no evidence of benefits of LH versus VH and the operating time was increased (WMD 41.5 minutes, 95%CI 33.7 to 49.4 minutes). There was no evidence of benefits of LH(a) versus LAVH and the operating time was increased for LH(a) (WMD 25.3 minutes, 95%CI 10.0 to 40.6 minutes). There was statistical heterogeneity in many of the outcome measures when randomised trials were pooled for meta-analysis. No other statistically significant differences were found. However, for some important outcomes, the analyses were underpowered to detect important differences, or they were simply not reported in trials. Data were notably absent for many important long-term outcome measures. AUTHORS' CONCLUSIONS: Significantly improved outcomes suggest VH should be performed in preference to AH where possible. Where VH is not possible, LH may avoid the need for AH, however the length of the surgery increases as the extent of the surgery performed laparoscopically increases, particularly when the uterine arteries are divided laparoscopically and laparoscopic approaches require greater surgical expertise. The surgical approach to hysterectomy should be decided by a woman in discussion with her surgeon in light of the relative benefits and hazards. Further research is required with full reporting of all relevant outcomes, particularly important long-term outcomes, in large RCTs, to minimise the possibility of reporting bias. Further research is also required to define the role of the newer approaches to hysterectomy such as TLH.

Female↗
PubMed2005

Endometrial destruction techniques for heavy menstrual bleeding.

BACKGROUND: Heavy menstrual bleeding (HMB) is a significant health problem in premenopausal women; it can reduce their quality of life and cause anaemia. First-line therapy has traditionally been medical therapy but this is frequently ineffective. On the other hand, hysterectomy is obviously 100% effective in stopping bleeding but is more costly and can cause severe complications. Endometrial ablation is less invasive and preserves the uterus, although long-term studies have found that the costs of ablative surgery approach the cost of hysterectomy due to the requirement for repeat procedures. A large number of techniques have been developed to 'ablate' (remove) the lining of the endometrium. The gold standard techniques (laser, transcervical resection of the endometrium and rollerball) require visualisation of the uterus with a hysteroscope and, although safe, require skilled surgeons. A number of newer techniques have recently been developed, most of which are less time consuming. However, hysteroscopy may still be required as part of the ablative techniques and some of them must be considered to be still under development, requiring refinement and investigation. OBJECTIVES: To compare the efficacy, safety and acceptability of methods used to destroy the endometrium to reduce HMB in premenopausal women. SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group Specialised Register of controlled trials (April 2004). We also searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2004), MEDLINE (1966 to July 2004), EMBASE (1980 to July 2004), Current Contents (1993 to week 38, 2001), Biological Abstracts (1980 to June 2001), PsycLIT (1967 to August 2001), CINAHL (1982 to July 2004) and the metaregister of controlled trials and ISRCTN register (December 2004). We also searched reference lists of articles and contacted pharmaceutical companies and experts in the field. SELECTION CRITERIA: Randomised controlled trials comparing different endometrial ablation techniques in women with a complaint of heavy menstrual bleeding without uterine pathology. The outcomes included reduction of heavy menstrual bleeding, improvement in quality of life, operative outcomes, satisfaction with the outcome, complications and need for further surgery or hysterectomy. DATA COLLECTION AND ANALYSIS: The two review authors independently selected trials for inclusion, assessed trials for quality and extracted data. Attempts were made to contact authors for clarification of data in some trials. Adverse events were only assessed if they were separately measured in the included trials. MAIN RESULTS: In the comparison of the newer non-hysteroscopic techniques (second generation) with the gold standard hysteroscopic ablative techniques (first generation) overall, surgery was an average of 15 minutes shorter (weighted mean difference (WMD) 14.9, 95% CI 10.1 to 19.7), local anaesthesia was more likely to be employed (odds ratio (OR) 8.3, 95% CI 3.9 to 17.5) and equipment failure was more likely (OR 4.2, 95% CI 1.3 to 13.8) with second-generation ablation. Women undergoing newer ablative procedures were less likely to have fluid overload, uterine perforation, cervical lacerations and hematometra than women undergoing the more traditional type of ablation and resection techniques (OR 0.13, 95% CI 0.04 to 0.5; OR 0.21, 95% CI 0.07 to 0.7; OR 0.12, 95% CI 0.05 to 0.3 and OR 0.25, 95% CI 0.09 to 0.7, respectively). However, women were more likely to have nausea and vomiting and uterine cramping (OR 2.3, 95% CI 1.5 to 3.4 and OR 1.8, 95% CI 1.1 to 2.9, respectively). Some differences were also found in amenorrhoea rates and satisfaction rates, but there did not appear to be a trend over time so these results may be due to chance. AUTHORS' CONCLUSIONS: Endometrial ablation techniques continue to play an important role in the management of HMB. The rapid development of a number of new methods of endometrial destruction has made systematic comparisons between methods and with the 'gold standard' of transcervical resection of the endometrium (TCRE) difficult. Most of the newer techniques are technically easier than hysteroscopy-based methods to perform. However, uterine perforation, which is the major complication of endometrial ablation, cannot be excluded without hysteroscopy. Overall, the existing evidence suggests that success rates and complication profiles of newer techniques of ablation compare favourably with TCRE, although technical difficulties with new equipment need to be ironed out.

Adult↗
PubMed2005

Laparoscopy versus laparotomy for benign ovarian tumours.

BACKGROUND: Over the last ten years laparoscopy has become an increasingly common approach for the surgical removal of benign ovarian tumours. There remains uncertainty as to the value of this intervention. This review has been undertaken to assess the available evidence for the benefits and harms of laparoscopic surgery for benign ovarian tumours compared to laparotomy. OBJECTIVES: To determine the efficacy, safety and cost of laparoscopic surgery compared with laparotomy in women with ovarian tumours assumed to be benign. SEARCH STRATEGY: We searched electronic databases, trials registers and reference lists of published trial reports. Review articles were also searched. SELECTION CRITERIA: All randomised controlled trials comparing laparoscopy versus laparotomy for benign ovarian tumours. DATA COLLECTION AND ANALYSIS: Three reviewers independently assessed each study's eligibility and quality and extracted data. MAIN RESULTS: Six randomised controlled trials were identified involving 324 patients. Three subgroups of ovarian tumours were considered: any histological type of benign ovarian tumour, dermoid cysts and endometriomata. Surgical outcomes: The mean duration of surgery was longer in the laparoscopy group compared to the laparotomy group overall (WMD 11.39; 95% CI 0.57 to 22.22). However, heterogeneity was present with substantial inconsistency (I(2)=87%) . The heterogeneity found in these analyses was likely to reflect differences in the patient populations. Adverse effects of surgery: The pooled estimate for febrile morbidity decreased for laparoscopy compared to laparotomy (Peto OR 0.34; 95% CI 0.13 to 0.88). The odds of any adverse effect of surgery (total number of complications - surgical injury and/or post operative complications) were decreased after laparoscopic procedures (Peto OR 0.26; 95% CI 0.12 to 0.55). Short-term recovery: VAS pain scores favoured laparoscopy (WMD -2.36; 95% CI -2.07 to -2.03) andt he odds of being pain free were significantly greater for the laparoscopy group compared to laparotomy (Peto OR 7.35; 95% CI 4.3 to 12.56). Mean length of hospital stay was shorter in the laparoscopy group with reduction 2.79 days (95% CI -2.95 to -2.62) compared to laparotomy. Economic outcomes: There was a significant reduction of US$1045 (95% CI -1361 to -726.97) in the laparoscopy group compared to the laparotomy group in one trial of women with any type of benign ovarian tumour. AUTHORS' CONCLUSIONS: In women undergoing surgery for benign ovarian tumours, laparoscopy is associated with a reduction in the following; febrile morbidity, urinary tract infection, post operative complications, post operative pain, days in hospital and total cost. These findings should be interpreted with caution as only a small number of studies were identified including a total of only 324 women and not all of the important outcomes were reported in each study.

Female↗
PubMed2005

Excisional surgery versus ablative surgery for ovarian endometriomata.

BACKGROUND: Endometriomata are endometriotic deposits within the ovary. The surgical management of these blood filled cysts is controversial. The laparoscopic approach to the management of endometriomata is favoured for as it offers the advantage of a shorter hospital stay, faster patient recovery and decreased hospital costs. Currently the commonest procedures for the treatment of ovarian endometriomata are either excision of the cyst capsule or drainage and electrocoagulation of the cyst wall. OBJECTIVES: The objective of this review was to determine the most effective technique of treating an ovarian endometrioma; either excision of the cyst capsule or drainage and electrocoagulation of the cyst wall, with regard to relief of pain, recurrence of the endometrioma, recurrence of symptoms and the subsequent spontaneous pregnancy rate. SEARCH STRATEGY: The reviewers searched the Cochrane Menstrual Disorders and Subfertility Group specialised register of trials (searched 15 Nov 2004), the Cochrane Register of Controlled Trials (The Cochrane Library, Issue 4, 2004), MEDLINE (1966-Nov 2004), EMBASE (1980- Nov 2004) and reference lists of articles, the handsearching of relevant journals and conference proceedings and by contacting leaders in the field of endoscopic surgery throughout the world. SELECTION CRITERIA: Randomised controlled trials of excision of the cyst capsule versus drainage and electrocoagulation of the cyst in the management of ovarian endometriomata. DATA COLLECTION AND ANALYSIS: Reviewers assessed eligibility and trial quality. MAIN RESULTS: No randomised studies of the management of endometriomata by laparotomy were found. Two randomised studies of the laparoscopic management of ovarian endometriomata of greater than 3cm in size were included. Laparoscopic excision of the cyst wall of the endometrioma was associated with a reduced rate of recurrence of the endometrioma (OR 0.41 CI 0.18-0.93), reduced requirement for further surgery (OR 0.21 CI 0.05-0.79), reduced recurrence rate of the symptoms of dysmenorrhoea (OR 0.15 CI 0.06-0.38), dyspareunia OR 0.08 CI 0.01-0.51) and non-menstrual pelvic pain (OR 0.10 CI 0.02-0.56). It was also associated with a subsequent increased rate of spontaneous pregnancy women who had documented prior sub-fertility (OR 5.21 CI 2.04-13.29). AUTHORS' CONCLUSIONS: There is some evidence that excisional surgery for endometriomata provides for a more favourable outcome than drainage and ablation, with regard to the recurrence of the endometrioma, recurrence of symptoms and subsequent spontaneous pregnancy in women who were previously subfertile. Consequently this approach should be the favoured surgical approach. However we found no data as to the effect of either approach in women who subsequently undergo assisted reproductive techniques.

Drainage↗
PubMed2005

Surgical approach to hysterectomy for benign gynaecological disease.

BACKGROUND: There are three approaches to hysterectomy for benign disease - abdominal hysterectomy (AH), vaginal hysterectomy (VH) and laparoscopic hysterectomy (LH). Laparoscopic hysterectomy has three further subdivisions - laparoscopic assisted vaginal hysterectomy (LAVH) where a vaginal hysterectomy is assisted by laparoscopic procedures that do not include uterine artery ligation, laparoscopic hysterectomy (which we will abbreviate to LH(a)) where the laparoscopic procedures include uterine artery ligation, and total laparoscopic hysterectomy (TLH) where there is no vaginal component and the vaginal vault is sutured laparoscopically. OBJECTIVES: To assess the most appropriate surgical approach to hysterectomy. SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders & Subfertility Group's Specialised Register of controlled trials (searched 23 March 2004), CENTRAL (The Cochrane Library Issue 1, 2004), MEDLINE (1966 to Mar 2004), EMBASE (1985 to Mar 2004), Biological Abstracts (1968 to Mar 2004), the National Research Register and relevant citation lists. SELECTION CRITERIA: Only randomised trials comparing one surgical approach to hysterectomy with another were included. DATA COLLECTION AND ANALYSIS: Twenty-seven trials that included 3643 participants were included. Independent selection of trials and data extraction were employed following Cochrane guidelines. MAIN RESULTS: The benefits of VH versus AH were shorter duration of hospital stay (WMD 1.0 day, 95%CI 0.7 to 1.2 days), speedier return to normal activities (WMD 9.5 days, 95%CI 6.4 to 12.6 days), fewer unspecified infections or febrile episodes (OR 0.42, 95%CI 0.21 to 0.83). The benefits of LH versus AH were lower intraoperative bloodloss (WMD 45.3 mls, 95%CI 17.9 to 72.7 mls) and a smaller drop in haemoglobin level (WMD 0.55g/L, 95%CI 0.28 to 0.82g/L), shorter duration of hospital stay (WMD 2.0 days, 95%CI 1.9 to 2.2 days), speedier return to normal activities (WMD 13.6 days, 95%CI 11.8 to 15.4 days), fewer wound or abdominal wall infections (OR 0.32, 95%CI 0.12 to 0.85), fewer unspecified infections or febrile episodes (OR 0.65, 95%CI 0.49 to 0.87), at the cost of longer operating time (WMD 10.6 minutes, 95%CI 7.4 to 13.8 minutes) and more urinary tract (bladder or ureter) injuries (OR 2.61, 95%CI 1.22 to 5.60). There was no evidence of benefits of LH versus VH and the operating time was increased (WMD 41.5 minutes, 95%CI 33.7 to 49.4 minutes). There was no evidence of benefits of LH(a) versus LAVH and the operating time was increased for LH(a) (WMD 25.3 minutes, 95%CI 10.0 to 40.6 minutes). There was statistical heterogeneity in many of the outcome measures when randomised trials were pooled for meta-analysis. No other statistically significant differences were found. However, for some important outcomes, the analyses were underpowered to detect important differences, or they were simply not reported in trials. Data were notably absent for many important long-term outcome measures. AUTHORS' CONCLUSIONS: Significantly improved outcomes suggest VH should be performed in preference to AH where possible. Where VH is not possible, LH may avoid the need for AH, however the length of the surgery increases as the extent of the surgery performed laparoscopically increases, particularly when the uterine arteries are divided laparoscopically and laparoscopic approaches require greater surgical expertise. The surgical approach to hysterectomy should be decided by a woman in discussion with her surgeon in light of the relative benefits and hazards. Further research is required with full reporting of all relevant outcomes, particularly important long-term outcomes, in large RCTs, to minimise the possibility of reporting bias. Further research is also required to define the role of the newer approaches to hysterectomy such as TLH.

Female↗
PubMed2004

Increase in peripheral blood mononuclear cell (PBMC)- and CD56+ cell-mediated killing of endometrial stromal cells by mycobacteria; a possible role in endometriosis immunotherapy?

BACKGROUND: Immunological therapies have shown promising results in the treatment of endometriosis. Mycobacteria are one of the most common immune therapies used in other diseases. We have assessed the effects of mycobacteria in altering the ability of peripheral blood mononuclear cells (PBMCs) and natural killer (NK) cells to kill endometrial stromal cells using an in vitro model. This may have implications in the immunotherapy of endometriosis. METHODS: Primary cultures of endometrial stromal cells were grown from female patients and PBMCs were extracted from healthy female volunteers. Effector cells (PBMCs or NK cells) were exposed to varying concentrations of mycobacteria before their ability to kill cultured endometrial cells was tested using a 51Cr-release assay. RESULTS: Treatment of effector cells with the Connaught Substrain Bacillus of Calmette and Guérin (BCG) led to increased killing of target cells by PBMCs and NK cells. The optimal concentration for treatment of effector cells with Connaught BCG was approximately 0.1 multiplicities of infection (m.o.i.). There was a trend towards increased killing after treatment with Pasteur BCG. CD56+ (NK) cells treated with BCG at 0.1 m.o.i. showed increased killing of target cells compared with untreated effector cells. CONCLUSIONS: Endometrial stromal cells are susceptible to killer cells activated by mycobacteria. This in vitro work suggests a possible role for mycobacteria in the immunotherapy of endometriosis.

Adult↗
PubMed2004

Anti-proliferative effect of mycobacteria, IFN-gamma and TNF-alpha on primary cultures derived from endometrial stroma: possible relevance to endometriosis?

PROBLEM: To assess the effects of mycobacteria and inflammatory cytokines on proliferation of endometrial stromal cells. An effect on endometrial stromal cell proliferation in vitro may suggest a similar effect on endometriotic cells in vivo. METHOD OF STUDY: Primary cultures of endometrial stromal cells were grown from female volunteers. Proliferation of cells was assessed by cell counting and incorporation of tritiated thymidine after exposure to mycobacteria or inflammatory cytokines. RESULTS: When assessed by cell counting, stromal cell growth was reduced following treatment with Connaught Bacillus of Calmette and Guérin (BCG) and Pasteur BCG: Mycobacterium smegmatis demonstrated a cytotoxic effect. Addition of the cytokines interferon (IFN)-gamma or tumour necrosis factor (TNF)-alpha at high concentrations led to a reduction in cell growth by 24 hr in two of three cell lines. A reduction in proliferation was also found when assessed by tritiated thymidine incorporation, which was statistically significant for Connaught BCG and M. smegmatis. CONCLUSIONS: Endometrial stromal cells are susceptible to the anti-proliferative effects of mycobacteria. The BCG and other mycobacteria are known immunomodulators in other disease conditions. Further work is required to assess whether these in vitro effects might translate into a useful therapy for endometriosis.

Cell Count↗
PubMed2004

EVALUATE hysterectomy trial: a multicentre randomised trial comparing abdominal, vaginal and laparoscopic methods of hysterectomy.

OBJECTIVES: To test the null hypothesis of no significant difference between laparoscopic hysterectomy (LH), abdominal hysterectomy (AH) and vaginal hysterectomy (VH) with regard to each of the outcome measures of the trial, and also to assess the cost-effectiveness of the alternatives. DESIGN: Patients were allocated to either the vaginal or abdominal trial by the individual surgeon according to their usual clinical practice. After allocation patients were then randomised to receive either LH or the default procedure in an unbalanced 2:1 manner. SETTING: Forty-three surgeons from 28 centres throughout the UK and two centres in South Africa took part in the study. PARTICIPANTS: Patients with gynaecological symptoms that, in the opinion of the gynaecologist and the patient, justified hysterectomy. INTERVENTIONS: Of 1380 patients recruited to the study, 876 were included in the AH trial and 504 in the VH trial. In the AH trial, 584 patients had a laparoscopic type of hysterectomy (designated ALH) and 292 had a standard AH. In the VH trial 336 had a VLH and 168 had a standard VH. A cost--utility analysis was undertaken based on a 1-year time horizon. Quality-adjusted life years (QALYs) were estimated using the EQ-5D. RESULTS: Compared with AH, LH was associated with a higher rate of major complications, less postoperative pain and shorter hospital stay, but took longer to perform. Securing the ovarian pedicles with laparoscopic sutures was used in only 7% of cases but was associated with 25% of the complications. At the 6 weeks postoperative point, ALH was associated with a significantly better physical component of the SF-12 (QoL questionnaire), better body image scale scores and a significantly increased frequency of sexual intercourse than AH. These differences were not observed at either 4 or 12 months after surgery. There were no significant differences in any measured outcome between LH and VH except that VLH took longer to perform and was associated with a higher rate of detecting unexpected pathology. Compared with VH, VLH had a higher mean cost per patient of GBP401 and higher mean QALYs of 0.0015, resulting in an incremental cost per QALY gained of GBP267,333. The probability that VLH is cost-effective was less than 50% for a large range of willingness to pay values for an additional QALY. Compared with AH, ALH had a higher mean cost per patient of GBP186 and higher mean QALYs of 0.007, resulting in an incremental cost per QALY gained of GBP26,571. CONCLUSIONS: ALH is associated with a significantly higher risk of major complications and takes longer to perform than AH. ALH is, however, associated with less pain, quicker recovery and better short-term QoL after surgery than AH. The cost-effectiveness of ALH is finely balanced and is also influenced by the choice of reusable versus disposable equipment. Individual surgeons must decide between patient-orientated benefits and the risk of severe complications. VLH was not cost-effective relative to VH. Recommendations for future research include the application and relevance of QoL measures following hysterectomy, and long-term follow-up; patient preferences; reducing complication rates; improving gynaecological surgical training; surgeon effect in surgery trials; care pathways for hysterectomy; additional pathology identification in LH and meta-analysis/further trial of VH versus LH.

Cost-Benefit Analysis↗
PubMed2003

The effects and effectiveness of laparoscopic excision of endometriosis: a prospective study with 2-5 year follow-up.

BACKGROUND: This study investigates the outcomes for women up to 5 years after laparoscopic excision of endometriosis. METHODS: In this prospective observational cohort study, 254 women with chronic pelvic pain were referred to two units specializing in minimal access surgical management of endometriosis. Of these, 216 women underwent surgical assessment and 176 were confirmed to have endometriosis. Questionnaires and visual analogue scale (VAS) scores for dysmenorrhoea, non-menstrual pelvic pain, dyspareunia and dyschesia as well as quality of life instruments; the EQ-5Dindex and EQ-5Dvas, Short-Form 12 (SF-12) and sexual activity questionnaires were completed pre-operatively. Intra-operative details of revised American Fertility Society (rAFS) stage, site of disease, associated tests, duration of surgery and complications were noted. Follow-up was performed by postal questionnaire and chart review. For women who had further surgery, rAFS stage, site of disease, other procedures and histology were all recorded. RESULTS: Pain scores were all significantly reduced at 2-5 years for dysmenorrhoea (median VAS baseline versus follow-up 2-5 years); 9 versus 3.3 (P < 0.0001), non-menstrual pelvic pain 8 versus 3 (P < 0.0001), dyspareunia 7 versus 0 (P < 0.0001) and dyschesia 7 versus 2 (P < 0.0001). Quality of life was improved for the EQ-5Dindex (P = 0.008 and the EQ-5Qvas (P = 0.03) and for sexual function with pleasure (P = 0.001) and habit (P = 0.012) being improved and discomfort being decreased (P = 0.001). The chance of requiring further surgery as determined by the Kaplan-Meier survival curve was 36%. A rAFS score of >70 was predictive of requiring further surgery (P = 0.03). Of women who had further surgery, endometriosis was found histologically in 68%. CONCLUSIONS: Laparoscopic excision of endometriosis significantly reduces pain and improves quality of life for up to 5 years. The probability of requiring further surgery is 36%. Return of pain following laparoscopic excision is not always associated with clinical evidence of recurrence.

Adult↗
PubMed2001

Laparoscopic surgery for pelvic pain associated with endometriosis.

OBJECTIVES: To assess the efficacy of laparoscopic surgery in the treatment of pelvic pain associated with endometriosis. The review aims to compare the effectiveness of any laparoscopic procedure versus any other treatment modality, including expectant management. SEARCH STRATEGY: The search strategy of the Menstrual Disorders and Subfertility Review Group was used to identify all publications that described or might have described randomised trials of laparoscopic surgery in the treatment of symptomatic endometriosis. For a full description of the Review Group strategy see the Review Group details. SELECTION CRITERIA: Trials were selected if they were randomised and compared the effectiveness of laparoscopic surgery in the treatment of pelvic pain associated with endometriosis, with other treatment modalities or placebo. DATA COLLECTION AND ANALYSIS: One study had data appropriate for inclusion within the review. This study compared laparoscopic laser surgery with diagnostic laparoscopy. Pain relief was the primary outcome measure. The data was extracted independently by two reviewers. MAIN RESULTS: In comparison to expectant treatment there is a significant degree of pain relief at six months after surgery with laser laparoscopic surgery for minimal, mild and moderate endometriosis. Odds Ratio (OR) 4.97, 95% Confidence Interval (CI) 1.85,13.39 REVIEWER'S CONCLUSIONS: The combined surgical approach of laparoscopic laser ablation, adhesiolysis and uterine nerve ablation is likely to be a beneficial treatment for pelvic pain associated with minimal, mild and moderate endometriosis. As only one trial is included in the analysis, this conclusion should be interpreted with caution.

Endometriosis↗
PubMed2001

Intraperitoneal gas drain to reduce pain after laparoscopy: randomized masked trial.

OBJECTIVE: To determine whether a drain placed in the peritoneal cavity during laparoscopy is both a clinical and cost-effective method of reducing postoperative pain. METHODS: Two hundred twenty-five women undergoing diagnostic or minor operative laparoscopic procedures were recruited. Women were assigned to receive either an intraperitoneal gas drain or a dummy drain during surgery. Sample size to detect a two-point difference in visual analogue score was estimated at 158 subjects, with 79 in each arm. The patients and nursing staff were unaware of the position of the drain. A visual analogue score was used to assess pain preoperatively and at 4, 24, and 48 hours postoperatively. Data on the experience of nausea, frequency of vomiting, and site of pain were collected. The analgesic and antiemetic use was recorded. An economic evaluation of the analgesic use and the material costs for the two groups was performed. RESULTS: One hundred sixty-one complete sets of data (72%) were available for analysis. The two groups were well matched for age, parity, previous surgery, body mass index, volume of carbon dioxide used, and operative time. No significant differences were found between the two groups with regard to the overall pain scores preoperatively (8 versus 7) or at 4 (30 versus 34), 24 (40 versus 44), and 48 (26 versus 26) hours postoperatively, after adjusting for multiple point testing. On assessment at different sites, the dummy drain group experienced shoulder pain more frequently at 4 (19 of 79 versus 10 of 82, P =.05) and 48 (16 of 79 versus 7 of 82, P =.03) hours postoperatively compared with the drain group. The placebo group had a 33% greater usage of oral analgesia after discharge, but this was $2.50 cheaper than the use of an intraperitoneal drain. No statistically significant differences were found between the groups with regard to nausea and vomiting postoperatively. CONCLUSION: An intraperitoneal drain after minor gynecologic laparoscopy decreases the frequency of shoulder pain and reduces postoperative analgesia requirements. However, it is less cost-effective to reduce pain using an intraperitoneal gas drain than simple oral analgesia after minor gynecologic laparoscopy.

Adult↗
PubMed2001

Inducible model to study negative strand RNA synthesis and assembly of hepatitis C virus from a full-length cDNA clone.

An inducible in vitro cell culture system was developed to assay HCV replication by direct biochemical means. A transcription plasmid containing a T7 promoter at the 5' end, full-length cDNA of the HCV genome, a ribozyme sequence from the antigenomic strand of hepatitis delta virus and a T7 terminator was prepared. To facilitate high-level transcription of HCV RNA, HepG2 cells were infected with replication deficient adenovirus containing the T7 RNA polymerase gene and later transfected with the transcription plasmid containing the full-length HCV genome. This transfection-based cell culture system expressed high levels of HCV structural (core, El and E2) and non-structural proteins (NS3 and NS5B) detectable by Western blot and immunofluorescence assays. Production of HCV RNA transcripts and presence of replicative negative strand of HCV was confirmed by ribonuclease protection assay indicating replication of HCV in the transfected HepG2 cell. The transfected HepG2 cells assembled 50-60 nm virus-like particles, which could be aggregated by anti-E2 antibodies. This model can be utilized for studying mechanisms of HCV replication, assembly of HCV particles and to test potential anti-HCV compounds.

Cloning, Molecular↗
PubMed2001

Endometrial laser intrauterine thermotherapy for the treatment of dysfunctional uterine bleeding: the first British experience.

Forty patients due to undergo endometrial ablation as a treatment for dysfunctional uterine bleeding were recruited to assess the efficacy and safety of endometrial laser intrauterine thermo-therapy using the gynelase. At 12 months the average menstrual score reduction was 88%, the amenorrhoea rate was 70%, and the hypomenorrhoea rate 16%. Four women (10%) have had a hysterectomy for persistent menorrhagia, and one (3%) for pelvic pain. One patient (3%) has had a further endometrial laser ablation. There were no major complications. and 34 patients (85%) were most satisfied with the treatment. The system is easy to use and has a short learning curve.

Adult↗
PubMed2000

The effect of endometriosis and its radical laparoscopic excision on quality of life indicators.

OBJECTIVE: To assess the effect of endometriosis and radical laparoscopic excision on the quality of life of women with this condition. DESIGN: A prospective study. SETTING: The Northern Endometriosis Centre at South Cleveland Hospital, Middlesbrough and St. James's University Hospital, Leeds. POPULATION: Fifty-seven consecutive patients undergoing laparoscopic excision of invasive endometriosis. METHODS: Questionnaires, both pre-operatively and four-month post-operatively, for a number of different symptoms associated with endometriosis were completed by patients. Details of fertility, previous treatments and quality of life as measured by SF12 and EuroQOL (EQ-5D) and sexual activity questionnaire, as well as linear pain scores for several symptoms, were recorded. Details of intra-operative findings was also collected. MAIN OUTCOME MEASURES: Effect of laparoscopic excision on pain scores and quality of life, operative findings, type of surgery, length of surgery and incidence of intra- and post-operative complications. RESULTS: Patients with endometriosis were severely ill with significant pain and impairment of quality of life and sexual activity. Four months after radical laparoscopic excision for deep endometriosis there was significant improvement in all the parameters measured including their quality of life based on EuroQOL evaluation: EQ-5D (0 x 595:0 x 729, P = 0 x 002) and EQ thermometer (68 x 9:77 x 7, P = 0 x 008); SF12 physical score (44 x 8:51 x 9, P = 0 x 015); sexual activity (habit P = 0 x 002, pleasure P = 0 x 002 and discomfort P < or = 0 x 001). Only the mental health score of SF12 failed to show any statistical improvement (47 x 1:48 x 4, P = 0 x 84). Symptomatically, there was a significant reduction in dysmenorrhoea (median 8 x 0:4 x 0, P < or = 0 x 001), pelvic pain (median 7 x 0:2 x 0, P < or = 0 x 001), dyspareunia (median 6 x 0:0 x 0, P < 0 x 001) and rectal pain scores (median 4 x 0:0 x 0, P < 0 x 001). Complications were noted, but were deemed to be acceptable for the extent of the surgery. CONCLUSIONS: This is an early analysis of the first 57 cases studied, but structured evaluation suggests that meaningful improvements in clinical symptoms and quality of life can be obtained with this approach with acceptable levels of operative morbidity. Further follow up of this series is required, but early evidence would suggest that the technique should be further evaluated as part of a randomised trial.

Endometriosis↗
PubMed2000

A cost effectiveness analysis of goserelin compared with danazol as endometrial thinning agents.

OBJECTIVE: To analyse the cost, effectiveness and cost effectiveness of two endometrial thinning agents prior to laser ablation for dysfunctional uterine bleeding: danazol and goserelin. SETTING: A district general hospital. DESIGN: A retrospective cost effectiveness analysis, from the perspective of the health service, based on data from an open, randomised, parallel group comparative study of 160 pre-menopausal women with dysfunctional uterine bleeding. METHODS: Within the trial, length of operation and duration of hospital stay was recorded for each woman. Resource use due to complications of surgery and adverse drug events was evaluated by one of the authors (R.G.). Additional surgery after completion of the study was collected using a postal questionnaire which was distributed to every woman who had undergone surgery. Resource use was costed using detailed unit costs from a specific NHS trust and from published sources. A cost effectiveness analysis was undertaken relating differential cost to differential rates of amenorrhoea at women's last point of follow up. RESULTS: Information on amenorrhoea was available from 138 women, of whom 111 had completed the questionnaire to indicate longer term follow up. Women who did not complete the clinical trial were not included in this economic evaluation. On average, women randomised to goserelin spent less time in theatre and on the ward. Based on longer term follow up, rates of retreatment were similar in the two groups. The mean (SD) health service cost of women in the goserelin group was pound sterling 323.84 (pound sterling 309.94), compared with pound sterling 243.45 (pound sterling 265.23) in the danazol group; median (range) costs were pound sterling 220.29 (pound sterling 191-pound sterling 2127) and pound sterling 159.76 (pound sterling 140-pound sterling 1426) in the two groups, respectively. These costs were significantly higher for goserelin (P = 0.0001). The goserelin group also had a higher rate of amenorrhoea (38.8% vs 28.6%, P = 0.23). Based on mean differences in cost, the incremental cost of goserelin per additional woman with amenorrhoea was pound sterling 788; based on median differences in cost the ratio was pound sterling 590. CONCLUSIONS: The shorter duration in theatre and stay in hospital provided a modest offset of the higher acquisition cost of goserelin, but the overall cost of management remained significantly higher than managing women with danazol. The rates of amenorrhoea indicated that goserelin was more effective at 24 weeks and approximately two years after surgery, although statistical significance was only achieved at 24 weeks. The economic impact of women withdrawn from treatment was not considered, but sensitivity analysis indicates that these women may have had a large effect on the overall result of this study. Purchasers will need to decide whether the additional cost of management with goserelin is justified by the increased rates of amenorrhoea and the reduced withdrawals from treatment.

Adult↗
PubMed1999

Laparoscopic hysterectomy.

The first laparoscopic hysterectomy using only laparoscopic techniques was performed around 10 years ago by Harry Reich. Such total laparoscopic hysterectomy (TLH) approach is surgically elegant but technically difficult. A number of alternative laparoscopic techniques to perform all or some of the hysterectomy have since been introduced to simplify the surgical technique but retain the major advantages of the approach, which is to avoid the use of a large laparotomy wound. The advantages of this approach have been well documented, but so far the laparoscopic route has been little used by the general gynecologic surgical community. Although it has been possible in some units to reduce the laparotomy rate for hysterectomy to 10%, there is evidence from the United Kingdom and the United States that still more than 70% of all hysterectomies are still being performed by the laparotomy approach. This chapter seeks to explain why this should be so and how appropriate training and acquisition of the necessary skills in operative laparoscopy and vaginal surgery can be achieved to ensure that all patients who may benefit by avoiding a laparotomy incision are given the opportunity to do so.

Costs and Cost Analysis↗
PubMed1999

Sexual activity questionnaires in clinical trials: acceptability to patients with gynaecological disorders.

OBJECTIVE: To assess the feasibility and acceptability of including sexual activity questionnaires in gynaecological clinical trials. DESIGN: A longitudinal quality of life study during the Maintenance Interferon Trial and the EVALUATE Hysterectomy Trial. SETTING: Gynaecology clinics and women's homes. SAMPLE: Ninety-six women with advanced ovarian cancer participating in the Maintenance Interferon Trial and 542 women undergoing a hysterectomy in the EVALUATE Hysterectomy Trial. METHODS: Quality of life questionnaires, including the sexual activity questionnaire, were completed by women prior to randomisation and periodically after randomisation. MAIN OUTCOME MEASURES: Compliance rates of the sexual activity questionnaire, both overall and with respect to the level of sexual functioning and age of the women. Attitudes of the women towards completing the questionnaire, and suitability of using the sexual activity questionnaire in clinical trials. RESULTS: Compliance rates of over 80% were achieved in both trials, both overall and for each questionnaire completed. The age of the woman did not appear to influence the completion of the questionnaire, nor did her level of sexual functioning. Women were supportive of the research and did not find the questionnaire intrusive. CONCLUSIONS: It is feasible to include sexual activity questionnaires in gynaecological clinical trials requiring repeated assessment of quality of life over a long period of time. The sexual activity questionnaire is an appropriate tool to carry out investigations of sexual functioning and is worth considering for use in future clinical trials.

Adult↗