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J B Trimbos

Publications and source records attributed to J B Trimbos.

At least 37 records · Page 2Linked to original sources

Effects of five different barrier materials on postsurgical adhesion formation in the rat.

Postsurgical adhesion formation is a significant clinical problem within every surgical specialism. Due to the problems that adhesions cause, a wide variety of adjunctive treatments to prevent the formation and reformation of adhesions have been proposed. One of the modalities that has been studied extensively and that has been showing the most promising results is the so-called barrier method. The purpose of the present study was to compare the efficacy of five of these barrier materials in the prevention of postsurgical adhesion formation in a standardized rat adhesion model. It was concluded that no beneficial effect of Ringer's lactate on adhesion formation was seen. Significant reductions (P < 0.0001) in adhesion percentages compared to control animals were seen with Polyactive((TM)), PRECLUDE Peritoneal Membrane((TM)), Seprafilm((TM)) and Tissucol((TM)), but only PRECLUDE Peritoneal Membrane and Seprafilm significantly reduced adhesions (P < 0.01) when the barrier-treated peritoneal defects were compared with contralateral control-side peritoneal defects. The results of our study suggest that Seprafilm and PRECLUDE Peritoneal Membrane are superior to Tissucol and Polyactive in preventing adhesion formation. When Polyactive was still attached to the site of application during the second laparotomy, similar results to Seprafilm and PRECLUDE Peritoneal Membrane were seen. Future studies on the efficacy of a material to decrease adhesion formation should always include a comparison of several control materials in the same model. Our study indicates that Seprafilm or PRECLUDE Peritoneal Membrane might be used as standards of control.

Analysis of Variance↗

The long learning curve of gynaecological cancer surgery: an argument for centralisation.

OBJECTIVE: To study the development of surgical performance of an unchanging surgical team over 13 years. DESIGN: Prospective, observational study. SETTING: A university hospital, The Netherlands. PARTICIPANTS: Three hundred and eight women who underwent surgical treatment for early cervical cancer. INTERVENTIONS: Radical hysterectomy and pelvic lymphadenectomy between 1 January 1984 and 31 December 1996. RESULTS: The surgical procedure and indication for treatment remained unchanged during the study period. This applied also to the surgical team. The women's age increased significantly during the study years, as was the case with the number of nodes removed. The depth of infiltration by the tumour increased steadily throughout the study, but this failed to reach statistical significance. The distribution of FIGO stages, percentage of positive lymph nodes, radicality of the surgical margins and post-operative morbidity remained the same. Overall, the five year survival rate was 83%; for women with negative nodes 91%, and for women with positive nodes 53%. Survival tended to improve during the course of the study, but this was not statistically significant. Blood loss during surgery decreased consistently during the whole study period, from a mean of 1,515 mL at the beginning of the study to a mean of 1,071 mL at the end (P < 0.0001). The operating time also diminished significantly by 8 minutes per year (P < 0.0001). In 1985 the average operating time was 270 minutes, compared with 187 minutes in 1996. CONCLUSIONS: These findings indicate that it takes a long time to acquire skill in the surgical treatment of early cervical cancer. Centralisation of relatively infrequent operations for cancer should be encouraged.

Adult↗

The case for completing the lymphadenectomy when positive lymph nodes are found during radical hysterectomy for cervical carcinoma.

BACKGROUND: In the present study we report on the results of a retrospective study on the effect on survival of the pelvic lymphadenectomy in a group of 294 patients with stage Ia2-IIa cervical carcinoma treated by radical hysterectomy from 1984 through 1996 at the Leiden University Medical Center. METHODS: Lymphadenectomy was called 'complete' when lymph node bearing tissue had been removed from 5 or 6 lymph node stations and 'not-complete' when this was the case in 1-4 stations. RESULTS: A radical hysterectomy was carried out in 294 patients. In 63 patients positive lymph nodes were found. Patients with positive nodes showed poorer 5 year survival: 64.5% compared to 90% in patients with negative nodes. In the univariate analysis the following factors were found to affect the presence of node metastases in a statistically significant way: age, tumor size, depth of infiltration, vaso-invasion, surgical margins, parametrial infiltration, stage and place of referral. In 63 patients with positive nodes, a complete lymphadenectomy was carried out in 23 patients, and in 40 patients the procedure was incomplete. All 63 patients were treated by adjuvant radiation therapy; those with complete lymphadenectomy had significantly less recurrences (25%) compared to those with incomplete lymphadenectomy (56%): the relative risk (RR) was 2.9 (95% ci: 1.3-6.7), p=0.012. After adjustment for other prognostic factors including tumor size, depth of infiltration and parametrial involvement, the complete lymphadenectomy showed an independent effect on disease free survival: RR= 3.2 (95% ci: 1.3-7.7), p=0.011. Prognostic factors were not significantly different for patients with complete or incomplete lymphadenectomy. CONCLUSIONS: From the results of this study, although retrospective and non randomized, it can be concluded that to complete removal of lymph nodes in combination with radical hysterectomy seems to have a beneficial effect on prognosis in case of positive nodes. The policy of aborting the procedure when lymph node metastases are found in frozen section should be questioned.

Carcinoma↗

Short-term effect of surgical trauma on rat peritoneal fibrinolytic activity and its role in adhesion formation.

BACKGROUND: Fibrin deposition, the primary step in the formation of post-surgical adhesions, is the result of a disbalance between the fibrin-forming and the fibrin-dissolving capacity of the peritoneum. Literature data suggest a transient reduction in local plasminogen activator activity after peritoneal trauma, which results in a reduction of fibrinolysis and permits deposited fibrin to become organized into fibrous, permanent adhesions. In the present study, the fibrinolytic parameters tissue-type plasminogen activator (tPA; antigen and activity) and plasminogen activator inhibitor type-1 (PAI-1; antigen and activity) were measured in peritoneal fluid, in peritoneal biopsies and in plasma to establish the time course of changes in fibrinolytic activity. DESIGN: A standardized peritoneal adhesion model in the rat. OUTCOME MEASURES: Analysis, over a 72-h period following surgical trauma. of the main fibrinolytic parameters in peritoneal lavage, in biopsies of damaged and undamaged peritoneum, and in plasma, and determination of fibrin and fibrin(ogen)-degradation products in peritoneal lavage fluid. RESULTS: At all time intervals, tPA antigen was found to be about six-fold increased in peritoneal lavage after surgical trauma. This significant rise in tPA antigen was accompanied by a large increase in its main inhibitor PAI-1, resulting in tPA activity levels similar to, or slightly higher than, those found in control animals. tPA activity was lowest at 4 h and increased thereafter. Also in biopsies from damaged peritoneum, tPA antigen was significantly increased. Tissue tPA activity was also lowest at 4 h, after which it increased, significantly so at 24 and 72 h. Similar, though smaller, changes were seen in the biopsies from undamaged areas of the peritoneal wall in operated rats. PAI-1 (antigen and activity) was not detected in peritoneal biopsies. Fibrin-related material (especially fibrin monomer/fibrinogen, an indicator of forming fibrin) in peritoneal fluid was slightly increased at 4 h, and abundantly present at 16 and 24 h, returning to control levels at 72 h. Fibrin degradation products were always present. From 2 h onward, adhesions were found. CONCLUSIONS: In contrast to the view that adhesions are formed as a result of a reduced fibrinolytic activity, our results demonstrate that tPA activity remained unchanged or slightly increased after surgical trauma, and point to increased fibrin formation rather than diminished fibrinolytic activity as the main cause of fibrin deposition after peritoneal trauma. Therapies directed at prevention of adhesion formation should therefore aim at avoiding massive fibrin production and at promoting fibrinolytic activity during the early period after trauma.

Animals↗

Influence of abdominal-wound closure technique on complications after surgery: a randomised study.

BACKGROUND: Wound complications that occur after closure of midline laparotomy remain challenging. A new continuous double-loop closure (CDLC) technique was developed to avoid wound rupture through resistance to high intra-abdominal pressure and continued approximation of wound edges. We investigated the efficacy of this technique. METHODS: We randomly assigned 390 patients undergoing midline laparotomy-wound closure with the commonly used continuous running suture (CRS) technique (n=204) or with the CDLC technique (n=186). We assessed the influence of closure technique on the rate of wound and other complications, with emphasis on wound dehiscence, pulmonary complications, and death. FINDINGS: The rate of wound complications did not differ significantly between groups. Pulmonary complications were seen in 11 patients (5.4%) in the CRS group, and in 32 patients (17.2%) in the CDLC group (p=0.0002). In the CRS group, 17 (8.3%) patients died, compared with 39 (21.0%) patients in the CDLC group (p=0.0004). INTERPRETATION: The CDLC technique should not be used. The lessened compliance of the abdominal wall, which raises intra-abdominal pressure for long periods, may increase the risk of postoperative pulmonary complications and death. The ideal closure technique should combine strength to prevent wound rupture with elasticity to adapt to increased intra-abdominal pressure.

Aged↗

Detection and typing of human papillomavirus in cervical carcinomas in Russian women: a prognostic study.

BACKGROUND: The correlation between human papillomavirus (HPV) infection and tumor prognosis in 159 Russian women with cervical carcinoma was investigated. The presence of various HPV types was correlated with the histologic parameters of the carcinomas and with their immunoreactivity with antibodies to p53, Ki-67-Ag, and bcl-2. METHODS: Formalin fixed, paraffin embedded tissue specimens representing 159 cases of International Federation of Gynecology and Obstetrics Stage I and II were used. HPV DNA was detected by polymerase chain reaction (PCR) using a general primer set that targets the L1 region and synthesizes a product of only 65 base pairs. The HPV types were determined by direct sequencing and compared with known HPV types. RESULTS: All 159 carcinomas were positive for HPV. HPV 16 (64.8%) was most frequently found, followed by HPV 18 (10.7%) and HPV 45 (8.2%). In 6 patients (3.8%), HPV types could not been further classified, and these cases were therefore categorized as HPV X. Although a trend was noted toward poorer prognosis for women with carcinomas harboring HPV types 16, 18, and 45 than for patients with carcinomas harboring HPV types 31, 33, 35, 52, 56, 58, and 68, the differences were not statistically significant. The prevalence of adenocarcinoma and adenosquamous carcinoma was higher among HPV 18 positive patients than among patients with the other known HPV types (P=0.0002). CONCLUSIONS: The rate of HPV positivity in these 159 cervical carcinomas was 100%. These findings challenge the assumption that HPV negative cervical carcinomas exist. This high rate might be attributed to the use of a new broad-spectrum HPV PCR test. HPV typing in cervical carcinoma was not significantly related to clinical outcome. HPV 18 was significantly more frequently found in adenocarcinoma and adenosquamous carcinoma. The possibility of classifying HPV 45 as an oncogenic high risk type should be considered.

Adult↗

Lymphedema and lymphocysts following lymphadenectomy may be prevented by omentoplasty: A pilot study.

OBJECTIVES: Pelvic lymph node dissection as part of the staging surgery for cervical carcinoma interrupts the afferent lymphatics, so the lymph drains retroperitoneally. New surgical techniques designed to leave the peritoneum open after the retroperitoneal dissection, in particular the application of a pedicled omentoplasty along the dissection route, have been advocated to prevent the formation of lymphocysts and lymphedema. We investigated the possible benefit of pedicled omentoplasty in preventing lymphocysts and lymphedema following pelvic lymph node dissection. METHODS: In this pilot study with historical controls we compared the formation of lymphocysts and lymphedema following two different surgical techniques for pelvic node dissection: group I (historical controls), in which the dorsal peritoneum was left open, and group II, in which the dorsal peritoneum was left open with application of a pedicled omentoplasty. In these two groups of gynecologic patients, we compared the lymph flow patterns and the occurrence of lymphedema following systemic pelvic lymphadenectomy. The two groups were of comparable clinical status and consisted of 12 (group I) and 10 (group II) patients. Lymphocysts, if any, were detected by CT scan, the lymph flow patterns were visualized by dynamic lymphscintography, and lymphedema was visualized by physical examination and magnetic resonance imaging of the groin and the upper leg. RESULTS: In both groups a distinct intraperitoneal absorption of the lymph fluid was observed. Pedicled omentoplasty seemed to facilitate the absorption or transport of lymph fluid, resulting in less lymphedema in the upper leg. CONCLUSION: It appeared that leaving the dorsal peritoneum open to give the lymph stream the opportunity to pour into the abdominal cavity is important in preventing lymphocysts and lymphedema. The dynamic lymphscintigraphy described in this paper showed that the intraabdominal lymph flow is absorbed by the peritoneum and even more quickly by the pedicled omentum.

Adult↗

Adjuvant radiotherapy following radical hysterectomy for patients with early-stage cervical carcinoma (1984-1996).

BACKGROUND AND PURPOSE: The aim of this study was to assess the results of treatment (surgery alone or surgery and postoperative radiotherapy) for early-stage cervical carcinoma and to determine the morbidity associated with adjuvant radiotherapy. A subset of these patients (n = 10) was irradiated postoperatively for tumor related negative prognostic factors only and this retrospective analysis was also performed to determine if this decision was right and if the selection for this treatment was based on the right criteria. MATERIAL AND METHODS: From 1984 to 1996, 233 women underwent radical hysterectomy as primary treatment of stage I or IIA cervical carcinoma. One hundred and fifty-six patients were treated with surgery alone (67%) and 77 patients (33%) received adjuvant radiotherapy for a, tumor related negative prognostic factors: the combination CLS(+), tumor size > or = 40 mm and poor differentiation grade or the combination tumor size > or = 40 mm and depth of invasion > or = 15 mm (n = 10), or b, positive surgical margins (n = 17), and/or c. lymphnode metastases (n = 42) and/ or d. parametrial involvement (n = 6). RESULTS: For the entire group the most important prognostic factor for survival and disease free survival was node positivity. Additional factors were depth of invasion and positive surgical margins. Thirty-five patients recurred of which 12 after surgery alone. In all these cases the relapse was in the pelvis (100%). Of the 23 recurrences after surgery and adjuvant radiotherapy 13 were seen in the pelvis (56%) (P = 0.003). All patients with negative prognostic factors and N0, received adjuvant radiotherapy (n = 10) and none of these patients recurred. The incidence of severe gastrointestinal radiation related side effects was low (2%). The incidence of lymphedema of the leg was 11% which was similar in the surgery alone group. CONCLUSIONS: The relatively low percentage of radiation related side effects together with 0% recurrence in a subgroup of node negative patients with high risk of recurrence, and a relatively low percentage of recurrence in the surgery alone group lead us to the conclusion that postoperative radiotherapy in special subsets of node negative patients is justified.

Adult↗

Vaccination with HPV16 peptides of patients with advanced cervical carcinoma: clinical evaluation of a phase I-II trial.

A phase I-II clinical trial was performed involving vaccination with HPV16 E7 peptides of patients suffering from HPV16 positive cervical carcinoma which was refractory to conventional treatment. Patients receiving the vaccine were HLA-A*0201 positive with HPV16 positive cervical carcinoma. The clinical trial was designed as a dose-escalation study, in which successive groups of patients received 100 micrograms, 300 micrograms or 1000 micrograms of each peptide, respectively. The vaccine consisted of two HPV16 E7 peptides and one helper peptide emulsified in Montanide ISA 51 adjuvant. 19 patients were included in the study, no adverse side-effects were observed. 2 patients showed stable disease for 1 year after vaccination; 15 patients showed progressive disease of whom 1 died during the vaccination treatment due to progressive disease; and 2 patients showed tumour-regression after chemotherapy following vaccination. A relative low count of lymphocytes before and after vaccination was present in 11/19 patients indicating that these patients were immunocompromised. This study shows that HPV16 E7 peptide vaccination is feasible, even in a group of patients with terminal disease. This paves the way for vaccinating patients with less advanced disease, whose immune system is less compromised by progressive disease.

Adult↗

Cervical carcinoma: can dynamic contrast-enhanced MR imaging help predict tumor aggressiveness?

PURPOSE: To determine whether fast dynamic contrast agent-enhanced magnetic resonance (MR) imaging can demonstrate tumor aggressiveness of cervical carcinoma in patients who are eligible for surgical treatment. MATERIALS AND METHODS: Dynamic contrast-enhanced MR imaging of cervical carcinoma was performed in 82 consecutive patients with stage I or IIA disease who were referred for radical hysterectomy. The maximum slope and amplitude of dynamic first-pass contrast enhancement were quantified. These parameters were correlated with histologic measures of tumor aggressiveness (tumor invasion depth, pelvic lymph node status). RESULTS: The analysis was based on tumors in 62 patients: 30 aggressive and 32 relatively nonaggressive tumors. Twenty patients were excluded from analysis owing to insufficient surgical data, tumor too small for accurate assessment, or technical problems. There were no significant differences between aggressive and nonaggressive tumors in terms of the first-pass contrast-enhancement parameters of slope (2.0 vs 2.1 arbitrary signal intensity units per second, P > .5) or amplitude (24.8 vs 27.8 arbitrary units, P > .2). CONCLUSION: Dynamic contrast-enhanced MR imaging does not facilitate differentiation between aggressive and nonaggressive tumors and therefore has no clinical role in assisting in treatment decisions in patients who are candidates for radical hysterectomy.

Adult↗

p53 protein overexpression is common and independent of human papillomavirus infection in squamous cell carcinoma of the vulva.

BACKGROUND: Human papillomavirus (HPV) infection and p53 abnormalities might both play a role in the carcinogenesis of subtypes of squamous cell carcinoma of the vulva. In this study, the authors investigated the prevalence of and the relationship between p53 overexpression and HPV infection in patients with vulvar carcinoma. METHODS: Immunohistochemical methods for the detection of p53 protein and consensus primer polymerase chain reaction (PCR) were used, followed by direct sequencing of the PCR product for the evaluation of HPV subtype infection. Sixty-six patients with squamous cell carcinoma of the vulva were available for this study. RESULTS: DO7, an anti-p53 monoclonal antibody, showed p53 overexpression in 35 carcinomas (53%). Consensus primer PCR showed HPV infection in 12 carcinomas (18%). No significant association was observed between p53 overexpression or HPV infection and tumor subtype. Approximately 57% of the HPV negative carcinomas and 33% of the HPV positive carcinomas had p53 overexpression. With regard to the patients with DO7 positivity in > or =50% of the nuclei only, significantly more HPV negative carcinomas were DO7 positive compared with HPV positive carcinomas (41% vs. 0%, respectively; P = 0.018). No relation was found between either HPV infection or p53 overexpression and disease free survival. CONCLUSIONS: p53 overexpression is common in both HPV positive and HPV negative carcinomas of the vulva. These findings indicate that these two both play a role in the pathogenesis of vulvar carcinoma, but do not influence disease free survival.

Adult↗

Human papillomavirus infection in squamous cell carcinoma of the vulva, in various synchronous epithelial changes and in normal vulvar skin.

OBJECTIVE: To investigate the prevalence of human papillomavirus (HPV) infection in various vulvar lesions. METHODS: HPV infection using consensus primer-PCR was studied in 66 patients with vulvar carcinoma and in the synchronous epithelial lesions. RESULTS: HPV infection was present in 13/66 carcinoma, in 1/33 VIN I, in 3/11 VIN II, in 8/16 VIN III, in 2/30 lichen sclerosus, in 1/37 squamous cell hyperplasia, and in 2/55 normal skin specimens. Normal skin from healthy controls showed HPV-negative specimens only. Patients with HPV-positive carcinomas were younger, presented in lower stages, and had high-grade VIN more often than those with HPV-negative carcinomas. CONCLUSIONS: In sum we found that all types of epithelial changes synchronous with carcinoma of the vulva showed HPV infection, indicating that they all might have malignant potential.

Adult↗

The relevance of various vulvar epithelial changes in the early detection of squamous cell carcinoma of the vulva.

The objective of this study is to evaluate the possible relevance of vulvar epithelial changes as a risk factor for squamous cell carcinoma of the vulva. The data of 66 women surgically treated for squamous cell carcinoma of the vulva have been analyzed. More than 6500 slides from the resection specimens were revised with special emphasis on concurrent epithelial changes. Synchronous epithelial changes were seen in 63 patients. Thirty-nine patients had synchronous vulvar intra-epithelial neoplasia grade 1 (VIN I), 10 VIN II and 13 VIN III. Thirty-one patients had synchronous lichen sclerosus and 49 squamous cell hyperplasia. The difference between the percentage of patients with epithelial changes diagnosed preceding their carcinoma (30%) and the percentage of patients that had synchronous epithelial changes after reviewing the specimen (95%) was striking. It was concluded that more careful diagnosis, treatment and follow-up of these conditions might lead to an earlier recognition of squamous cell carcinoma of the vulva and therefore to a better prognosis.

Journal Article↗

Complications of laparoscopy: a prospective multicentre observational study.

OBJECTIVE: To determine the incidence and describe the complications of laparoscopic procedures in The Netherlands. DESIGN: A nationwide prospective multicentre observational study. METHODS: Data on complications were registered from 1 January to 31 December 1994 by 72 hospitals. Any unexpected or unplanned event requiring intra-operative or post-operative intervention was defined as a complication. Complications were classified in two groups: approach and technique related complications. Complication rates were compared with these already published. RESULTS: Of 25,764 laparoscopic procedures, 145 complications occurred (rate 5.7 per 1000 [/1000]); two deaths occurred. In 84 women laparotomy was necessary (rate 3.3/1000). In 83 cases (57%; 95% CI for approach = 49-65%) the complication was caused by the surgical approach; in 62 cases (43%) the technique was at fault. Haemorrhage of the epigastric vein and intestinal injury, often requiring laparotomy (90% of cases) were the most frequently observed complications. The complication rate was 2.7/1000 for diagnostic laparoscopic procedures, 4.5/1000 for sterilisation and 17.9/1000 (chi 2 = 127; dF = 2; P < 0.001) for operative laparoscopy. The highest incidence was registered for complications occurring during laparoscopic (assisted) hysterectomy. Stepwise logistic regression analysis showed that previous laparotomy and surgical experience were associated with complications requiring laparotomy. CONCLUSIONS: Most complications occurred during operative laparoscopic procedures (rate 17.9/1000). Residents in training are required to learn diagnostic laparoscopy and sterilisation and this training programme results in a fall in the risk of the complications. However, operative laparoscopic procedures are still hazardous, especially laparoscopic hysterectomy. Women with a previous laparotomy are particularly at risk.

Female↗

Continuous double loop closure: a new technique for repair of laparotomy wounds.

BACKGROUND: Wound dehiscence after midline laparotomy is a life threatening complication, most frequently caused by sutures cutting through the fascia. Increasing the strength of the sutured wound could prevent wound rupture. METHODS: In an experimental study in the rat, the simple continuous suture (SCS), loop suture (LS), interrupted double loop closure and continuous double loop closure (CDLC) techniques were evaluated. Dehiscence pressure and volume were measured after closing a standard laparotomy. RESULTS: Laparotomies closed with the newly developed CDLC technique could withstand by far the highest intra-abdominal pressure before dehiscence (P < 0.0002). Wounds closed with this technique remained well approximated regardless of the intra-abdominal pressure, unlike wounds closed with the frequently used SCS and LS methods. CONCLUSION: In all animals sutured with the CDLC technique the intact abdominal wall ruptured lateral to the wound at dehiscence pressure, indicating that the bursting strength of the sutured wound was higher than that of the intact abdominal wall.

Animals↗

DNA index reflects the biological behavior of ovarian carcinoma stage I-IIa.

The prognostic significance of histologic grade, morphometric analysis, and DNA flow cytometry was evaluated in 64 patients with well-differentiated (group A) and 30 patients with moderately and poorly differentiated (group B) early-stage (FIGO stages Ia, Ib, Ic, and IIa) epithelial ovarian cancer. The extent of the well-defined staging procedure was assessed strictly in every patient. Of 94 patients, 13 had recurrent ovarian cancer (5 from group A and 8 from group B) and 12 of these patients died. A significant difference was found between groups A and B for 5-year disease-free survival (91% versus 75%), the menopausal status, surgical staging procedure, volume percentage epithelium (VPE), morphometric category, DNA ploidy, and DNA index, but not for histologic cell type. For the 94 patients from groups A and B together, a significant difference was observed between diploid and aneuploid tumors with regard to mean mitotic activity index (MAI), mean VPE, and the morphometric categories that combined MAI and VPE characteristics. Prognostic reliability for the occurrence of tumor relapse was highest for DNA index class, followed by tumor grade and DNA ploidy pattern. With multivariate analysis the primary prognostic factor for disease-free survival appeared to be the DNA index. DNA index class was the only parameter that added prognostic information when histologic grade was selected as the primary prognostic factor. If the DNA index was taken as primary prognostic factor, none of the tested parameters including tumor grade added useful information. It was concluded that the DNA index is a primary prognostic factor for disease-free survival in early-stage ovarian cancer patients. Morphometric measurements do not add supplementary prognostic information.

Adult↗

Pain relief during and following outpatient curettage and hysterosalpingography: a double blind study to compare the efficacy and safety of tramadol versus naproxen. Cobra Research Group.

OBJECTIVE: To compare the analgetic efficacy and side-effects of Naproxen and Tramadol following the outpatient VABRA aspiration or hysterosalpingography. SETTING: Ninety-one patients from the gynaecology clinics of two university hospitals and one municipal-teaching hospital. DESIGN: Multicentre double blind randomized clinical trial. Computerised randomisation, stratification per-centre. METHODS: Semiquantitative assessment of the two drugs was performed by the patient and the gynaecologist using a 1- to 6-point scale. Pain, stress and well-being was scored by the patient using the visual analog scale (VAS) and the verbal description scale (VDS), ranging from 0 (good) to 100 (bad). Side-effects during the first 24 h postoperatively were recorded by the patient in a diary. RESULTS: The analgetic efficacy (pain, stress and well-being) of Naproxen and Tramadol was identical. Subjective assessment by the patient and the doctor also revealed no differences between Naproxen and Tramadol. Side-effects of Tramadol, however, were significantly more severe than those of Naproxen and this phenomenon was responsible for a lower ability to proceed with normal activities in the Tramadol group. CONCLUSION: Tramadol is a good alternative for Naproxen at outpatient VABRA or HSG procedures when Naproxen is contra-indicated.

Adult↗