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Safety and tolerability of the new contraceptive sponge Protectaid.

OBJECTIVE: This study was undertaken to assess the efficacy, safety and acceptability of two different-dose regimens of the Protectaid contraceptive sponge. METHODS: The toxic effects of two forms of the new vaginal contraceptive sponge, Protectaid, in the cervical and vaginal tissues were studied. Both types were impregnated with F-5 gel containing different doses of nonoxynol-9 (NX9; 0.5% and 0.125%). The sponge was used by 35 women aged 20-35 years (mean 28.7 years) randomly allocated into two groups (Group A: 0.5% NX9, n = 20; Group B: 0.125% NX9, n = 15). RESULTS: During a 12-month period both regimens demonstrated a 91.4% overall contraceptive efficacy. Colposcopic examinations showed no significant cervical or vaginal lesions in either group, except for two cases at the 2-week and 3-month examinations in Group A women. In the former, inflammatory changes of little clinical significance were seen and the colposcopic appearance of the vagina was non-specific. In this case, the focal lesions were accompanied by dilated capillaries (hyperemia). In the second case, degenerative inflammatory changes, with the inflammatory foci varying in shape and distribution, were observed. Cervical cultures taken 6 months after the start of treatment showed the presence of Mycoplasma hominis and Candida albicans in one and two cases, respectively, in Group A. In Group B, cervical cultures taken at 3 months showed Gardnerella vaginalis and beta-hemolytic streptococci group B in one and two cases, respectively. CONCLUSION: The potent spermicidal and protective properties of this new contraceptive sponge may be of benefit to the sexually active female. Since the sponge was very well accepted by both the study participants and their sexual partners, it can be considered as a valuable barrier method.

Administration, Intravaginal↗

CO2 laser surgery for vulvar intraepithelial neoplasia. Excisional, destructive and combined techniques.

OBJECTIVE: To evaluate CO2 laser excision, vaporization and combined techniques for treatment of vulvar intraepithelial neoplasia (VIN). STUDY DESIGN: Thirty-nine cases of VIN 3, 15 cases of VIN 2 and 9 of VIN 1, for a total of 63 patients with histologically proven VIN, underwent laser excision or vaporization under colposcopic guidance, using local anesthesia, in an outpatient setting or after day-surgery admission. Clinical aspects, cervical intraepithelial neoplasia (CIN) and vaginal intraepithelial neoplasia (VaIN) association, types of CO2 laser treatment, follow-up, recurrences and second treatments were evaluated. RESULTS: Twenty-seven (41.3%) patients underwent laser vaporization, and 37 (58.7%) with VIN 3, underwent laser excision or the combined technique. Colposcopic and biopsy examinations of patients with VIN revealed three cases of CIN 3 and nine cases of VaIN 3; two patients had concomitant VIN 3, CIN 3 and VaIN 3. Local anesthesia, using 2% carbocaine, and outpatient or day-surgery treatments were possible in all cases. A small incidence of intraoperative complications (4.8%) and absence of postoperative complications were observed. A single session was curative in 76.9% of patients treated with laser vaporization and in 78.4% of those treated with laser excision. Eleven cases of recurrent VIN and two cases of invasive vulvar carcinoma were observed during follow-up. A second laser procedure was carred out in all cases of relapsed VIN, with an overall cure rate of 96.8% after two treatments. Radical vulvectomy associated with inguinal-femoral lymphadenectomy was performed in the two cases of invasive carcinoma. CONCLUSION: CO2 laser surgery permits treatment of VIN in an outpatient or day-surgery setting under local anesthesia with excellent cosmetic and functional results. The treatment can also be adjusted to the patient's specific needs, with the possibility of calibrating the depth of the vaporized and removed tissues. Excisional treatment is the preferred method because it permits histologic evaluation of the excised tissue and detection of possible occult early invasion.

Adult↗

Electrocoagulation diathermy for the treatment of cervical dysplasia and carcinoma in situ.

This report presents further experience in the use of electrocoagulation diathermy for the treatment of patients with cervical intraepithelial disease. By means of the colposcope it was possible to select a group of nonpregnant patients, in whom a proven noninvasive lesion was located entirely within range of the colposcope. This group, comprising 450 patients, has been treated by means of electrocoagulation diathermy, and with followup, only 28 patients have shown evidence of a residual lesion; in 8 of these the residual lesion has been eradicated subsequently by repeat diathermy treatment. Significant complications following electrocoagulation diathermy occurred in 13 patients (3%). The overall apparent cure rate for electrocoagulation diathermy was 95.4%.

Biopsy↗

The making of a colposcopist. A safe and sensible approach.

A program was established to determine the accuracy of colposcopy at our institution. Forty-three patients with cytologic or histologic evidence of severe dysplasia or worse underwent diagnostic conization following satisfactory colposcopy. Thirty patients subsequently had either therapeutic conization or hysterectomy preceded by biopsy only. In all 73 cases, the surgical specimen did not reveal a more advanced lesion. However, when the colposcopy was unsatisfactory, the rate of error was 20.8%. It is our opinion that colposcopy is a safe and valuable technique as long as one recognizes the need for training and understands the indications for further diagnostic studies. The use of the colposcope for the evaluation of abnormal cervical cytology has increased steadily over the last few years, and several excellent courses are now offered throughout the United States. Armed with a certificate from such a course, many gynecologists then become self-proclaimed colposcopists in spite of warnings to the contrary by the instructors. In addition, supervision by experienced personnel is not always available. How, then, does one indeed become an accomplished colposcopist to the point that he or she can safely spare the patient the risk, inconvenience and expense of diagnostic cervical conization? Although several recent publications 2,5,6,9,11 document the diagnostic accuracy of colposcopically directly biopsies, we feel each individual should develop and evaluate his or her own skill before altering or abandoning conventional methods of diagnosis and management. The purpose of this report is to present our experience with colposcopy utilizing a program which can perhaps serve as a model to other clinicians.

Biopsy↗

Colposcopy, cervical cytology and human papillomavirus detection as screening tools for cervical cancer.

A cohort of 77 women referred for routine screening or investigation of Pap test abnormality underwent colposcopic examination. Pap-stained liquid-based preparations were diagnosed and categorized according to the Bethesda system. Residual material on the sampling device was used to detect high-risk oncogenic human papillomavirus DNA. Although the colposcopic failure rate was higher than that of cytology, no lesion was missed when both methods were used together. High-risk types were recorded in 24% of patients with atypical squamous cells of undetermined significance, 45% with low-grade squamous intraepithelial lesions and 79% with high-grade squamous intraepithelial lesions--indicating that the efficacy of cytological screening can be improved by papillomavirus detection.

Adult↗

[Wait-and-see policy versus loop excision after two consecutive Pap-2 cervical smears: over time less surgery and an equivalent outcome; no substantial contribution to be expected from the detection of high risk human papillomavirus].

OBJECTIVE: To determine the number interventions and outcomes in patients referred with two consecutive Pap 2 cervical smear results who were managed either by a wait-and-see policy or aggressively, and to determine whether triage with high-risk human papillomavirus (hr-HPV) detection, resulting in the referral of only hr-HPV positive patients, would lead to the detection of all patients with cervical intraepithelial neoplasia (CIN). DESIGN: Retrospective comparison and retrospective cohort study. METHOD: 282 patients referred in 1997/'99 with 2 consecutive Pap 2 cervical smears in the screening program were included. Patients referred to the UMC St Radboud Hospital (n = 140; mean age: 45 years) underwent a colposcopy during which only lesions suggestive for CIN 3 were treated. All other colposcopic lesions (CIN 2 or less) were not treated but followed prospectively. Patients referred to the Canisius Wilhelmina Hospital (CWZ) (n = 142; mean age: 44 years) underwent colposcopy during which all colposcopic lesions (including CIN 2 or less) were treated directly. The two groups were compared in terms of the final cytological follow-up, the number of loop excisions, and the number of patients with CIN. The mean follow up was 40 months. In the first group, the effect of triage using hr-HPV detection was also investigated retrospectively. RESULTS: With the wait-and-see approach, statistically significantly fewer diathermic loop excisions were done: 13 versus 124. After the follow-up period there was no statistically significant difference between the two groups in terms of the number of patients with persisting Pap 2: 16 (11%) versus 12 (8%). Triage with hr-HPV detection would identify all patients with CIN 3, 50% of the patients with CIN 2, and none of the patients with CIN 1; of the 48 hr-HPV-positive women, 1 had a CIN 3 lesion and 3 had a CIN 2 lesion; of the remaining 92 women, 2 had a CIN 1 lesion and 3 had a CIN 2 lesion. CONCLUSION: The wait-and-see approach led to fewer interventions, while the number of women with persisting Pap 2 smears was not higher than with the aggressive approach. Triage with hr-HPV may reduce the number of referrals and colposcopies, but follow-up remains necessary in all women regardless of hr-HPV status.

Adult↗

[The value of local application of a vasoconstrictive peptide during colposcopy (author's transl)].

The vasoconstrictive peptide (Ornithin-Vasopressin, experimental name POR 8) was tested regarding its usefulness in colposcopic diagnosis and differential diagnosis. In a concentration of 5 IE/2 ml of normal saline the compound resulted in good hemostasis in 88% of the cases. The differential diagnosis of the atypical transformation zone was much easier because of the difference in constriction between normal and abnormal vessels. The local application of "POR 8" is a valuable aid in the colposcopic diagnosis and differential diagnosis of the bleeding cervix in the cervix with an atypical transformation zone.

Administration, Topical↗

Diagnostic value of cytology and colposcopy for squamous and glandular cervical intraepithelial lesions.

The main objective of work was to determine a diagnostic value of cytology and colposcopy as a method of screening and differential diagnosis, as well as to determine the relative value of some colposcopic features of squamous and glandular cervical intraepithelial lesions. Cytological diagnosis and colposcopy findings is compared with histological ones for 187 patients with intraepithelial lesions (142 squamous and 45 glandular ones with or without squamous components) and determined the sensitivity and positive predictive value of cytology and colposcopy, including the types of colposcopic abnormalities associated with squamous/glandular intraepithelial lesions. The sensitivity of cytology as a screening method for SIL (squamous intraepithelial lesions) is 89% and for GIL (glandular intraepithelial lesions) 98%. Positive predictive value of differential cytology for SIL is 59% and for GIL 53%. Sensitivity of colposcopy for both lesions' type is 87%. Acetowhite epithelium occurs for more often with SIL, whereas atypical vessels and unequal, dilated gland openings with GIL (p < 0.05). Cytology and colposcopy as screening methods have a high sensitivity. Nevertheless, cytology is far more accurate in determining differential diagnosis of SIL than GIL and some colposcopy abnormalities suspicious of GIL should be further tested in praxis.

Carcinoma, Squamous Cell↗

Human papillomavirus in women. A three-year experience in a county hospital colposcopy clinic.

The human papillomavirus (HPV) has been associated with cervical dysplasia and carcinoma. This report summarizes the authors' experience with HPV-related problems over three years, 1987-89, while managing 1,644 women at a county hospital colposcopy clinic. Probes for HPV DNA were not used, and the diagnoses were made with cytologic and histologic criteria alone. The percentage of patients referred to the clinic with HPV found on routine Papanicolaou smears rose significantly, from 3 in 1987 to 18 in 1989. Fifteen percent of those referred because of HPV on a Papanicolaou smear were found to have cervical intraepithelial neoplasia (CIN) grade II or III after they were evaluated at the clinic. Of the 367 cases of biopsy-proven cervical HPV, only 33 (9%) were recorded on Papanicolaou smears performed immediately before the biopsy, and 140 (38%) also had concomitant, biopsy-proven CIN, grade II or III. Of the 195 instances in which the colposcopic impression was simple HPV without CIN, 46 (24%) had high-grade CIN on biopsy. We conclude that the proportion of patients with HPV-associated problems is increasing, that the Papanicolaou smear is not sensitive in detecting cervical HPV infections, that patients with HPV changes found on Papanicolaou smears should be evaluated with colposcopy and that lesions that appear colposcopically to be simple HPV should undergo biopsy to rule out the presence of high-grade CIN.

Biopsy↗

[Viral and/or intraepithelial lesions of the lower female genital tract: diagnostic and prognostic value of in situ molecular hybridization].

Fourteen patients (mean age 37 years) suffering from viral and/or intraepithelial cervico-vagino-vulvar pathologies underwent colposcopic and cyto-histological tests and molecular hybridization. The following types of HPV were assayed: 6/11-16/18-31/35/51 in cytological tissues (exocervical scraping) and biopsy material immersed in paraffin and fixed in formalin buffered with 10% PBS. The aim of the study was to identify different types of HPV using molecular hybridisation in situ. The paper reports the results and correlations with colposcopic, cytological and histological diagnosis, and then discuss the clinico-biological and prognostic aspects of this method.

Adult↗

Abnormal Papanicolaou smears. Comparison of cytology, colposcopy and cervical swab DNA hybridization.

Cervical swab sampling for DNA hybridization was performed on 89 women attending a colposcopy clinic. In situ hybridization studies for human papillomavirus (HPV) types 6/11, 16/18 and 31/33/35 were performed on the specimens. Biopsy specimens were obtained from 65 patients. The cytologic, colposcopic and histologic results were classified into five groups and assigned a score of 0-5, depending upon the diagnosis. An increasing score correlated positively with the presence of HPV, especially types 16/18 and 31/33/35. A comparison was made of the sensitivity, specificity, and positive and negative predictive values for the standard method of colposcopic evaluation versus the standard method combined with DNA cervical swab sampling. No significant changes in the parameters were found when the DNA cervical swab was added.

Colposcopy↗

An evaluation of human papillomavirus testing as part of referral to colposcopy clinics.

OBJECTIVE: To determine the usefulness of human papillomavirus (HPV) testing as a triage method for predicting which women referred to a colposcopy clinic were most likely to have histologically confirmed cervical intraepithelial neoplasia (CIN). METHODS: Papanicolaou tests, ViraPap tests for HPV infection, and colposcopically directed biopsies were performed concurrently on 482 women referred to a student health colposcopy clinic. RESULTS: The results demonstrated that HPV positivity was associated with a greatly increased likelihood of histologic confirmation of CIN, especially among women with concurrent cytologic findings that were negative or showed only atypical squamous cells of undetermined significance. CONCLUSIONS: Testing for HPV appears to have a role in the triage of students now being referred to our colposcopy clinic. A combination of HPV testing and repeated cytologic screening would provide reasonably sensitive screening for cervical neoplasia while limiting the use of colposcopic services, which are currently overburdened. The eventual usefulness of HPV testing will depend on the cost and availability of colposcopy services, the cost of Papanicolaou tests, the cost and accuracy of HPV tests, and the predictive value of HPV detection in the population being screened.

Adult↗

[Role of colposcopy in the diagnosis of human papillomavirus infection of the uterine cervix].

Among 6706 women screened by cytology, only 9 (0.13%) showed evidence of human papillomavirus infection (HPVI). In 133 women examined by colposcopy for abnormal cytology or/and suspected lesions on the cervix, 41 (30.8%) showed subclinical papillomavirus infection (SPI) while 17.4% and 5.3% showed HPVI by histopathology and cytology, respectively. The conformation rate between colposcopy and pathology was 69.6%. Sixty-nine specimens out of 133 colposcopy guided biopsies were assayed by HPV-DNA dot hybridization with 6B/11, 16, 18 probes to detect the presence of HPV-DNA in the cervical specimens. Thirty-nine (56.5%) gave a positive result. The colposcopic predictive value of positive result for HPVI was 76.7%. The difference between colposcopy (59%) and pathology (20.5%) is statistically significant (P less than 0.01). These results suggest that colposcopy is superior to cytology and histopathology for the detection of SPI in the cervix. In colposcopy HPV-DNA positive women, aceto-while-epithelium was most common (28.2%). As it is difficult to differentiate SPI from cervical intraepithelial neoplasia especially the Grade I lesion by colposcopy, discrimination criteria are proposed together with the chief colposcopic features of SPI.

Colposcopy↗

Colposcopy findings of CIN and cancer-like lesions of the cervix in pregnancy.

In the course of routine colposcopy evaluation of the cervix in all the cases examined and treated in our clinic we pay attention to the cervical lesions accompanying pregnancy, which are macroscopically and/or colposcopically, and even frequently histologically suspected of CIN and/or cancer. These lesions include findings connected with HPV-infection, i.e. fully developed papillomas, subclinical forms of this infection, as well as the decidual ectopy of the cervix. Fully developed papillomas estimated not only macroscopically and colposcopically, but sometimes also histologically yield falsely positive pictures of cancer, and the decidual transformations on the cervix can be misinterpreted as non-epithelial malignant changes. The incidence rate of cervical papillomas is about 1% in non-selected material; one half of these cases occurs in pregnancy. Decidual ectopy was diagnosed in our material in 6.2% of pregnant women, chiefly between 21 and 30 years of age, and only in single cases in non-pregnant women. On the basis of our routine colposcopy examinations of the cervix in pregnancy conducted for over 30 years, the authors present the colposcopy-clinical signs of these CIN and carcinoma-like changes of the cervix in pregnancy. These observations are colpophotographically documented and allow us to differentiate between these changes and pre- and neoplastic lesions of the cervix in pregnancy.

Carcinoma in Situ↗

Natural history of the minimally abnormal Papanicolaou smear.

OBJECTIVE: We sought to determine the natural history of the cytologic and colposcopic changes in patients with minimal abnormalities on their Papanicolaou smears (atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion [SIL]). METHODS: Between November 1988 and November 1990, 632 women with abnormal Papanicolaou smears as listed above were evaluated at Los Angeles County-Olive View Medical Center. Each had review of cytology, repeat Papanicolaou smear, and colposcopy of the lower genital tract. We excluded those who were pregnant or had findings demonstrative of moderate dysplasia or worse, or had a cervical biopsy for any other indication. Women with symptomatic vaginal discharge were treated and remained in the study. Subjects were followed every 3 months with repeat Papanicolaou smear and colposcopy for a minimum of 9 months. If at any time the Papanicolaou smear or colposcopy was consistent with moderate dysplasia or worse, directed biopsies and endocervical curettage were performed, and treatment was given accordingly. Two hundred ninety-four patients fulfilled all inclusion criteria and had adequate follow-up data. RESULTS: Nine months after enrollment, 42 of 91 women (46.2%) with atypical squamous cells had persistent changes, none had progression, and 49 (53.8%) had regression to normal. In those with low-grade SIL, 37 of 203 cases (18.2%) persisted, seven (3.4%) progressed, and 159 (78.3%) regressed by 9 months. Patients in the first group were more likely to have persistence of the cytologic abnormalities than were those in the second (P less than .01). Only the latter group progressed to high-grade dysplasia during the 9-month study interval. CONCLUSION: The majority of women with confirmed minimal cytologic changes on Papanicolaou smear will have complete colposcopic and cytologic regression over a short interval.

Adult↗

[Stage IA1 squamous cell carcinoma of the uterine cervix: a report of 30 cases].

BACKGROUND & OBJECTIVE: The preoperative diagnosis and management of stage IA(1) squamous carcinoma of the cervix remains a controversial subject. The aim of this study was to discuss diagnosis and appropriate management options of this disease. METHODS: Clinical data and pathological materials of 30 patients with stage IA(1) squamous carcinoma of the cervix, who were treated in Cancer Hospital, Chinese Academy of Medical Science, Peking Union Medical College between 1992 to 2001, were reviewed. RESULTS: Seven of 30 patients (23.3%) had neither specific symptoms nor signs. Twenty-three patients had cytological examination with the positive rate of 86.9% (20/23). Colposcopy was performed in 23 of the women; the accuracy of colposcopical impression was 78.2%(18/23). Of 10 endocervical curettage (ECC) specimens, 4 cases had abnormal pathology. Among 30 patients, 22 (73.3%) were treated with radical hysterectomy, 6 with simple hysterectomy, and 2 with cold conization only. There was no parametrical involvement and no positive vaginal margin in any of 28 patients who had hysterectomy. Lymphadenectomy was performed in 8 cases; the mean number of lymph nodes removed was 22, and no metastasis was found. The two conization specimens had free surgical margin. The preoperative diagnosis agreed with final diagnosis in only 56.7% (17/30); there was statistically significant difference between them (P< 0.01). During median 34 months follow-up (range, 17-111 months), no developed recurrences and no died from cancer. CONCLUSION: The diagnostic accuracy of colposcopically directed biopsy is quite poor for stage IA(1) cervical carcinoma. Cervical cold conization may increase the diagnostic accuracy and may be recommended for patients who desire conservation of fertility.

Adult↗

Diethylstilbestrol exposure.

Diethylstilbestrol is a synthetic nonsteroidal estrogen that was used to prevent miscarriage and other pregnancy complications between 1938 and 1971 in the United States. In 1971, the U.S. Food and Drug Administration issued a warning about the use of diethylstilbestrol during pregnancy after a relationship between exposure to this synthetic estrogen and the development of clear cell adenocarcinoma of the vagina and cervix was found in young women whose mothers had taken diethylstilbestrol while they were pregnant. Although diethylstilbestrol has not been given to pregnant women in the United States for more than 30 years, its effects continue to be seen. Women who took diethylstilbestrol during pregnancy have a slightly higher risk of breast cancer than the general population and therefore should be encouraged to have regular mammography. Women who were exposed to diethylstilbestrol in utero may have structural reproductive tract anomalies, an increased infertility rate, and poor pregnancy outcomes. However, the majority of these women have been able to deliver successfully. Recommendations for gynecologic examinations include vaginal and cervical digital palpation, which may provide the only evidence of clear cell adenocarcinoma. Initial colposcopic examination should be considered; if the findings are abnormal, colposcopy should be repeated annually. If the initial colposcopic examination is normal, annual cervical and vaginal cytology is recommended. Because of the higher risk of spontaneous abortion, ectopic pregnancy, and preterm delivery, obstetric consultation may be required for pregnant women who had in utero diethylstilbestrol exposure. The male offspring of women who took diethylstilbestrol during pregnancy have an increased incidence of genital abnormalities and a possibly increased risk of prostate and testicular cancer. Routine prostate cancer screening and testicular self-examination should be encouraged.

Breast Neoplasms↗

Access to colposcopy services for high-risk Canadian women: can we do better?

BACKGROUND: Despite overall decreasing mortality from cervical cancer, selected groups of Canadian women continue to have suboptimal access to diagnostic and treatment interventions for cervical cancer. In this paper, we present an evaluation of a colposcopy program developed to improve attendance for colposcopy in a lower socio-economic and immigrant population. METHODS: All women attending the North Hamilton Community Health Centre (CHC) who required colposcopic assessment and were referred to a newly developed colposcopy program based at the CHC were evaluated. Attendance rates for consultation, follow up and treatment in women referred for colposcopy were compared retrospectively for the CHC-based colposcopy program and concurrently with the regional colposcopy clinic (RCC). RESULTS: Women referred to the CHC colposcopy program had a significant reduction in their no-show rate after the introduction of the locally based colposcopy program (17.2% vs. 1.3%, p<0.01). Comparing the same time periods, there was no significant reduction in the default rate at the RCC (2.5% vs. 3.3%, p=0.21). Despite serving a population of women who were at higher risk for non-attendance, patients at the CHC had a default rate for appointments similar to that of the RCC (1.3% vs. 3.3%, p=0.55) after the introduction of the local colposcopy program. CONCLUSIONS: Lower socio-economic status and immigrant women receiving care from a CHC-based colposcopy program had a significant decrease in their no-show rate for colposcopic evaluation after the introduction of the on-site program. Consideration must be given to locating diagnostic colposcopy programs in settings more accessible to women who require these services the most.

Adolescent↗