Operative Hysteroscopy vs Vacuum Aspiration for Incomplete Spontaneous Abortion: A Randomized Clinical Trial.

Importance: Vacuum aspiration is commonly used to remove retained products of conception in patients with incomplete spontaneous abortion. Scarring of the uterine cavity may occur, potentially impairing future fertility. A procedural alternative, operative hysteroscopy, has gained popularity with a presumption of better future fertility. Objective: To assess the superiority of hysteroscopy to vacuum aspiration for subsequent pregnancy in patients with incomplete spontaneous abortion who intend to have future pregnancy. Design, Setting, and Participants: The HY-PER randomized, controlled, single-blind trial included 574 patients between November 6, 2014, and May 3, 2017, with a 2-year duration of follow-up. This multicenter trial recruited patients in 15 French hospitals. Individuals aged 18 to 44 years and planned for surgery for an incomplete spontaneous abortion with plans to subsequently conceive were randomized in a 1:1 ratio. Interventions: Surgical treatment by hysteroscopy (n = 288) or vacuum aspiration (n = 286). Main Outcomes and Measures: The primary outcome was a pregnancy of at least 22 weeks' duration during 2-year follow-up. Results: The intention-to-treat analyses included 563 women (mean [SD] age, 32.6 [5.4] years). All aspiration procedures were completed. The hysteroscopic procedure could not be completed for 19 patients (7%), 18 of which were converted to vacuum aspiration (8 with inability to completely resect, 7 with insufficient visualization, 2 with anesthetic complications that required a shortened procedure, 1 with equipment failure). One hysteroscopy failed due to a false passage during cervical dilatation. During the 2-year follow-up, 177 patients (62.8%) in the hysteroscopy group and 190 (67.6%) in the vacuum aspiration (control) group achieved the primary outcome (difference, -4.8% [95% CI, -13% to 3.0%]; P = .23). The time-to-event analyses showed no statistically significant difference between groups for the primary outcome (hazard ratio, 0.87 [95% CI, 0.71 to 1.07]). Duration of surgery and hospitalization were significantly longer for hysteroscopy. Rates of new miscarriages, ectopic pregnancies, Clavien-Dindo surgical complications of grade 3 or above (requiring surgical, endoscopic, or radiological intervention or life-threatening event or death), and reinterventions to remove remaining products of conception did not differ between groups. Conclusions and Relevance: Surgical management by hysteroscopy of incomplete spontaneous abortions in patients intending to conceive again was not associated with more subsequent births or a better safety profile than vacuum aspiration. Moreover, operative hysteroscopy was not feasible in all cases. Trial Registration: ClinicalTrials.gov Identifier: NCT02201732.

Operative hysteroscopy versus vacuum aspiration for incomplete spontaneous abortion (HY-PER): study protocol for a randomized controlled trial.

BACKGROUND: Incomplete spontaneous abortions are defined by the intrauterine retention of the products of conception after their incomplete or partial expulsion. This condition may be managed by expectant care, medical treatment or surgery. Vacuum aspiration is currently the standard surgical treatment in most centers. However, operative hysteroscopy has the advantage over vacuum aspiration of allowing the direct visualization of the retained conception product, facilitating its elective removal while limiting surgical complications. Inadequately powered retrospective studies reported subsequent fertility to be higher in patients treated by operative hysteroscopy than in those treated by vacuum aspiration. These data require confirmation in a randomized controlled trial comparing fertility rates between women undergoing hysteroscopy and those undergoing vacuum aspiration for incomplete spontaneous abortion. METHODS: After providing written informed consent, 572 women with incomplete spontaneous abortion recruited from 15 centers across France will undergo randomization by a centralized computer system for treatment by either vacuum aspiration or operative hysteroscopy. Patients will not be informed of the type of treatment that they receive and will be cared for during their hospital stay in accordance with standard practices at each center. The patients will be monitored for pregnancy or adverse effects by a telephone conversation or questionnaire sent by e-mail or post over a period of two years. In cases of complications, failure of the intervention or diagnosis of uterine cavity disease, patient care will be left to the discretion of the medical center team. DISCUSSION: If our hypothesis is confirmed, this study will provide evidence that the use of operative hysteroscopy can increase the number of pregnancies continuing beyond 22 weeks of gestation in the two-year period following incomplete spontaneous abortion without increasing the incidence of morbidity and peri- and postoperative complications. The standard surgical treatment of this condition would thus be modified. This study would therefore have a large effect on the surgical management of incomplete spontaneous abortion. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02201732 ; registered on 17 July 2014.

Patient eligibility criteria for a surgical treatment that enhances tissue sealing by use of a medicated sponge: observational study ELITE.

RATIONALE: The application of a haemostatic agent in general surgery, in addition to its effect on bleeding, also provides tissue sealing and adhesion. A sponge drug is used with some actions of resection and wide dissection, without knowledge of the eligibility of patients. In this study, we sought to identify clusters of patients for which the medicated sponge enhances tissue sealing. METHODS: Observational study (ELITE), from a panel of selected surgeons from hospitals in France in several surgical areas: abdominal, gynaecology, urology and thoracic. The survey identified the criteria for using the sponge TachoSil® in their surgical practices involving n = 683 patients. A multiple correspondence analysis (MCA) followed by an ascending hierarchical classification (AHC) was used in order to identify the eligibility criteria for the application of the sponge for tissue sealing in addition to hemostasis. RESULTS: The most relevant classification was based on 9 groups of patients for which the sponge was used. 6 of them are mainly linked with the kind of lesion, 2 with the site of application and the latest one with the type of operation. CONCLUSIONS: The ELITE study revealed that the TachoSil® sponge was used mainly during surgery, requiring a reinforcement of the resection tissue sealing. The expected objective was successfully reached in 97% of the cases.

MRI anatomical study of the outside-in transobturator suburethral tape procedure.

BACKGROUND: This study aims to clarify the relationship between the outside-in transobturator suburethral tape and the anatomical structures at the blind passage of the obturator foramen, and to detail the tape position, shape, and the factors on which they are dependent. METHODS: MRI scans were performed on 30 patients operated on with a dermal porcine collagen suburethral tape, indicated for urodynamically proven stress incontinence. RESULTS: The lateral bladder wall was the closest structure to the tape at the passage of the obturator foramen, whereas vascular injuries appeared to be minimal using the outside-in technique. The distance from tape to bladder neck was correlated with the distance from tape to pubococcygeal line (PCL) (p=0.001), and with urethral length (p=0.049). From the obturator foramen to its passage under the urethra, the tape was U-shaped with a cranio-caudal and antero-posterior orientation. The cranio-caudal tape shape was correlated with the distance between the tape and the PCL (p=0.002), and to the patient's anatomical characteristics: distance between the bladder neck and the pubis (p=0.01), and the urethral length (p=0.01). The antero-posterior shape was correlated with the urethral length (p=0.02). CONCLUSION: The lateral bladder wall is the structure most at risk during the outside-in transobturator suburethral tape procedure. The distance from tape to bladder neck is dependent on the vertical position of the tape. The tape shape is dependent on both tape position under the urethra and the patient's anatomical characteristics.