Pyomyoma after abortion: Uterus conserving surgery is possible to maintain fertility. Case report.

INTRODUCTION: Pyomyoma is a rare complication associated with high rates of morbidity and mortality. PRESENTATION OF CASE: We report the case of a 28-year-old nulligravida patient presenting pyomyoma following a spontaneous abortion at fourteen weeks and four days. Fourteen days following spontaneous miscarriage she was referred to the hospital with abdominal pain and fever. An antibiotic treatment was initiated. However, after ten days, the patient's condition deteriorated and a decision for an emergency laparotomy made. The pyomyoma was successfully resected and the patient's postoperative recovery was uneventful. A new pregnancy was confirmed two years later. DISCUSSION: The diagnosis of pyomyoma can be difficult but surgical treatment is often indicated. Performing a prompt myomectomy avoids the need for hysterectomy, preserving future fertility. CONCLUSION: Pregnancy is possible following uterine sparing treatment of pyomyoma.

Reliability of Endocervical Curettage in the Diagnosis of High-grade Cervical Neoplasia and Cervical Cancer in Selected Patients.

AIM: To analyze the reliability of endocervical curettage (ECC) in the diagnosis of high-grade cervical intraepithelial neoplasia and cervical cancer, and to identify risk factors associated with diagnostic underestimation. MATERIALS AND METHODS: A retrospective study was carried-out involving 445 patients who underwent ECC for: endocervical lesion incompletely visible on colposcopy or inaccessible to biopsy; atypical glandular cells on smear, or discrepancy between colposcopic impression and cytological abnormalities. RESULTS: Comparison between ECC and final diagnosis showed a perfect match in 362 patients (81.3%). For 189 patients with pre-cancerous or cancerous endocervical lesions, the sensitivity, specificity, and positive and negative predictive values were 87.3%, 96.9%, 95.4% and 91.9%, respectively. No clinical, cytological or colposcopic characteristics were associated with significantly increased risk of diagnostic underestimation with ECC. CONCLUSION: ECC is a very reliable tool for reducing the number of unnecessary treatments, without increasing the risk of allowing some lesions to evolve into cancer.

Equipment failure: causes and consequences in endoscopic gynecologic surgery.

STUDY OBJECTIVE: To determine the incidence of equipment failure in gynecologic endoscopy and investigate causes and consequences. DESIGN: A prospective observational single-center study between January and April 2006. SETTING: Gynecologic surgery department of a university hospital. INTERVENTIONS: In all, 116 endoscopic interventions were included: 62 laparoscopies, 51 operative hysteroscopies, and 3 fertiloscopies. Emergency and equipment testing procedures were excluded. MEASUREMENTS AND MAIN RESULTS: Equipment malfunctions were divided into 4 categories with regard to imaging, transmission of fluids and light, the electric circuit, and surgical instruments. We also found cases with faulty connections between elements. Factors including human error, loss of time, and actual or potential consequences were analyzed. At least 1 equipment failure was noted in 38.8% of operative procedures, 41.9% of laparoscopies, and 37.3% of hysteroscopies. Fluid, gas, and light transmission was faulty in 36.2%, surgical instruments in 29.3%, the electric circuit in 22.4%, and imaging in 12.1%. Of malfunctions, 46.6% were a result of faulty connection between 2 elements. The most common cause for concern was bipolar forceps and cables in laparoscopy (42.3%) and the assembly of small parts in hysteroscopy (47.4%). Personnel were implicated in 43% of cases (nurses in 72%, surgeons in 12%, both in 16%). One equipment failure increased the total duration of laparoscopy by 7% and of hysteroscopy by 20%. The mean delay was 5.6+/-4.0minutes by equipment failure. Of the incidences, 19% could have led to serious complications for the patient; however, no morbidity or mortality actually occurred in this series. CONCLUSION: Equipment malfunction is common in endoscopic surgery and concerns both laparoscopy and hysteroscopy. Consequences are potentially serious. It is mandatory to identify and rectify causes of equipment failure so as to optimize the daily use of endoscopic instruments and improve patient safety. The implementation of systematic checklists is currently under evaluation.

Efficiency of MR imaging to orientate surgical treatment of posterior deep pelvic endometriosis.

OBJECTIVE: The purpose of this retrospective study was to evaluate the accuracy of MRI using pelvic-phased-array and endocavitary coils in detecting intestinal wall invasion by an endometriotic nodule. MATERIALS AND METHODS: Forty-seven patients (32.1 +/- 4.2 years) who were planned for a surgical cure of deep endometriosis underwent MRI with conventional sequences using both coils. A thin bright layer on T(2)-w with enhancement on post-Gd T(1)-w defined our MR pattern for muscular layer involvement. MR results were correlated with surgical and pathological findings of the removed nodule. RESULTS: MR results for Group 1 (both coils) achieved a sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 100-63%, 96-92%, 90-70%, 100-85%, and 97-83% for endovaginal coil and phased-array coil, respectively. Group 2 (phased-array coil) had a sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 73%, 93%, 84%, 88%, and 87% for this coil, respectively. CONCLUSION: Combined pelvic-phased-array and endovaginal coils are better than phased array alone in the detection of intestinal wall invasion. Easy to perform, it has to be considered as a preoperative staging for deep posterior endometriosis to orientate the surgical management.

Methodological and ethical quality in phase III--breast cancer trials.

OBJECTIVE: The gold standard of Evidence Based Medicine remains the randomised controlled trial (RCT), which is the only tool that allows an approach to the "therapeutic truth". To reach credible conclusions, these trials need to be perfect in methodological and ethical quality. The purpose of this study is to evaluate methodological quality (MQ), ethical quality (EQ) and compliance with ethical requirements in phase III randomized clinical trials of breast cancer treatment. STUDY DESIGN: MQ was evaluated by the Jadad-scale and EQ by the Berdeu-score for all the randomised controlled clinical trials (RCT) (n = 137), published between January 2001 and December 2005 in 11 international journals. RESULTS: Mean MQ was 9.88 +/- 1.43. MQ was insufficient (Jadad score pound 9) for 49 RCT (35,8%). Mean EQ was 0.45 +/- 0.12. Mean EQ for RCT with insufficient MQ (n = 49) was 0.43 +/- 0.12; Mean EQ for RCT with good MQ (Jadad score > 9)(n = 88) was 0.46 +/- 0.11. There was significant improvement in MQ depending on the year in which the study was started (p = 0.002). EQ was independent of the year of study's start (p = 0.134).There was no relationship between MQ or EQ and the number of patients included in the study (p = 0.53 and p = 0.1). There was a tendency towards correlation between MQ and EQ (p = 0.052), but the correlation between these two variables could not be considered as significant (r = 0.67). Informed consent from patients (ICP) was not obtained in 5.8% (n = 8) of the RCTs and the approval of a research ethics committee (REC) was not mentioned in 26.3% (n = 36) of the RCTs. CONCLUSIONS: Good MQ and reporting of ethical requirements (EQ) reflects the respect shown to the patients during the whole research process. There are still deficiencies in EQ and MQ. Quality improvement requires education and appropriation by the scientific community, in particular, medical staff, of methodological and ethical basic rules concerning trials involving human beings.

Disseminated intravascular coagulation after laparoscopic multiple myomectomy with use of icodextrin: a case report.

Uterine leiomyomas are by far the most common benign genital tumors. The prevalence rates vary from 20% to 50%. Myomectomy is a standard surgical treatment and is prescribed for patients who wish to preserve their fertility. The laparoscopic approach allows a shorter hospital stay, faster recovery, less intraoperative blood loss, less postoperative pain, and possibly fewer adhesions than abdominal myomectomy when performed by skilled surgeons. Myomectomy is associated with the risk of excessive blood loss and adhesions formation. Reports of disseminated intravascular coagulation complicating this type of surgery are rare, and no prior cases have been reported in the literature after the use of 4% icodextrin. Randomized trials support the use of absorbable adhesion barriers to reduce adhesion formation. A case of disseminated intravascular coagulation after laparoscopic multiple myomectomy with the use of 4% icodextrin solution is described.

Tubal perforation by ESSURE microinsert.

Female tubal sterilization remains the most widely used method of permanent contraception worldwide. Recent studies have shown the new sterilization technique by ESSURE microinsert to be an effective method with decided advantages for the patient in terms of morbidity associated to a quick recovery. We discuss the possible hysteroscopic signs of tubal perforation and the right measures to take if a perforation is suspected, with respect to the possible complications and contraceptive failure.

Disclosure of competing financial interests and role of sponsors in phase III cancer trials.

Financial relationships between industry, researchers and academic institutions are becoming increasingly complex, raising concern about sponsors' involvement in the conduct of biomedical research. A review of published randomised trials (RCTs) in cancer research was performed to assess adherence to the 1997 disclosure requirements and to document the nature of the disclosed interests. Source(s) of study support, author-sponsor relationships and the role of the study sponsor were assessed for all RCTs published between 1999 and 2003 in 12 international journals. A total of 655 cancer RCTs were identified. Of these, 516 (78.8%) disclosed the source of sponsorship. The nature of the relationship between the authors and the study sponsor was included in 219 of the 227 industry-sponsored studies. The most commonly cited relationships were (131 studies had multiple relations): grants (93.6%); employment (39.2%); consultant/honorarium (12.7%) and stock ownership and participation in a speaker's bureau (12, 5.5% each). Only 41 (18%) of the 227 industry-sponsored RCTs reported the role of the sponsor. Of these, 20 explicitly stated that the sponsor had no role in the study. Twenty-one papers described the sponsor's role, the degree of sponsor involvement was variable and usually described vaguely. Among these papers, four stated that researchers had full access to all data, one that the researchers had no limits on publication and one that 'the decision to submit the paper for publication was determined by the study sponsor'. In conclusion, no researcher should be expected to produce 'findings' without full access to the data, freedom from interference in analysis and interpretation and liberty to publish all results, however disappointing to the stakeholder they may be. In the meantime, researchers do well to arm themselves with the rules for research partnerships and editors to take on the role of watchdog.

[Methodological and ethical quality in phase III cancer trials: role of the cooperative group]. / Rôle des groupes coopérateurs dans la qualité éthique et méthodologique des essais de phase III en cancérologie.

Phase III clinical trials (CT) are carried out more and more often in a multicentric way, under the aegis of one or more cooperative groups (CG). The goal of this study was to analyze the influence of the GC on ethical quality (EQ) and methodological quality (MQ) in phase III cancer CT. EQ (Berdeu-score) and MQ (Jadad scale) were assessed for all CTs (n=231) published between 1999 and 2001 in 10 international journals. The impact of CG on EQ and MQ was evaluated with an univariate analysis. 140 ECR (60.6%) were carried out under the aegis of a CG. There was no improvement of the MQ and EQ for the trials carried out under the aegis of a CG. The methodological score (Jadad) was of 9.9 +/- 1.15 for the CT-CG (+) and of 9.8 +/- 1.28 for the CT-GC (-) (p=0.7). The ethical score (Berdeu) was of 0.43 +/- 0.14 for the CT-CG (+) and of 0.40 +/- 0.11 for the CT-CG (-) (p=0.08). Interim analysis, defined stopping rules and independent monitoring were more frequent for the CT-CG (+) and were respectively 37.8% vs 15.4%, 20.7% vs 8.8%, 19.3 vs 6.6%. 31.9% of the CT-CG (-) and 19.3% of the CT-CG (+) were financed by industry (p=0.03). The CG have a major role to play in the protection of the patient in CT, because they monitored trials from the conception to the publication and communication of results.