Procedural sedation and analgesia versus general anesthesia for hysteroscopic myomectomy (PROSECCO trial): A multicenter randomized controlled trial.

BACKGROUND: Hysteroscopic resection is the first-choice treatment for symptomatic type 0 and 1 fibroids. Traditionally, this was performed under general anesthesia. Over the last decade, surgical procedures are increasingly being performed in an outpatient setting under procedural sedation and analgesia. However, studies evaluating safety and effectiveness of hysteroscopic myomectomy under procedural sedation are lacking. This study aims to investigate whether hysteroscopic myomectomy under procedural sedation and analgesia with propofol is noninferior to hysteroscopic myomectomy under general anesthesia. METHODS AND FINDINGS: This was a multicenter, randomized controlled noninferiority trial conducted in 14 university and teaching hospitals in the Netherlands between 2016 and 2021. Inclusion criteria were age ≥18 years, maximum number of 3 type 0 or 1 fibroids, maximum fibroid diameter 3.5 cm, American Society of Anesthesiologists class 1 or 2, and having sufficient knowledge of the Dutch or English language. Women with clotting disorders or with severe anemia (Hb < 5.0 mmol/L) were excluded. Women were randomized using block randomization with variable block sizes of 2, 4, and 6, between hysteroscopic myomectomy under procedural sedation and analgesia (PSA) with propofol or under general anesthesia (GA). Primary outcome was the percentage of complete resections, assessed on transvaginal ultrasonography 6 weeks postoperatively by a sonographer blinded for the treatment arm and surgical outcome. Secondary outcomes were the surgeon's judgment of completeness of procedure, menstrual blood loss, uterine fibroid related and general quality of life, pain, recovery, hospitalization, complications, and surgical reinterventions. Follow-up period was 1 year. The risk difference between both treatment arms was estimated, and a Farrington-Manning test was used to determine the p-value for noninferiority (noninferiority margin 7.5% of incomplete resections). Data were analyzed according to the intention-to-treat principle, including a per-protocol analysis for the primary outcome. A total of 209 women participated in the study and underwent hysteroscopic myomectomy with PSA (n = 106) or GA (n = 103). Mean age was 45.1 [SD 6.4] years in the PSA group versus 45.0 [7.7] years in the GA group. For 98/106 women in the PSA group and 89/103 women in the GA group, data were available for analysis of the primary outcome. Hysteroscopic resection was complete in 86/98 women (87.8%) in the PSA group and 79/89 women (88.8%) in the GA group (risk difference -1.01%; 95% confidence interval (CI) -10.36 to 8.34; noninferiority, P = 0.09). No serious anesthesiologic complications occurred, and conversion from PSA to GA was not required. During the follow-up period, 15 serious adverse events occurred (overnight admissions). All were unrelated to the intervention studied. Main limitations were the choice of primary outcome and the fact that our study proved to be underpowered. CONCLUSIONS: Noninferiority of PSA for completeness of resection was not shown, though there were no significant differences in clinical outcomes and quality of life. In this study, hysteroscopic myomectomy for type 0 and 1 fibroids with PSA compared to GA was safe and led to shorter hospitalization. These results can be used for counseling patients by gynecologists and anesthesiologists. Based on these findings, we suggest that hysteroscopic myomectomies can be performed under PSA in an outpatient setting. TRIAL REGISTRATION: The study was registered prospectively in the Dutch Trial Register (NTR 5357; registration date: 11 August 2015; Date of initial participant enrollment: 18 February 2016).

Recurrence after surgery for endometrioma: a systematic review and meta-analyses.

IMPORTANCE: Endometriosis is an inflammatory disease, with different forms of expression and a variety of complaints. An endometrioma, an ovarian cyst with endometrium-like lining, is one of the most common expressions of abdominal endometriosis. These endometriomas can, in addition to medical treatment, be treated surgically. After surgery, hormonal therapy is still frequently used, for treatment of endometriosis in general and prevention of recurrence of endometriomas specifically. However, not all women want or can receive postoperative hormonal treatment. It is important for this group to know the risk of anatomical recurrence of ovarian endometrioma after surgery for an endometrioma. OBJECTIVE: To determine the recurrence rate for surgically treated endometrioma, without postoperative hormonal treatment. DATA SOURCES: We performed a systematic literature review and meta-analyses, according to the PRISMA guidelines. MEDLINE, EMBASE, and the Cochrane Library were searched until May 2023. The literature search was limited to women with endometrioma who received surgical treatment without postoperative hormonal treatment. STUDY SELECTION AND SYNTHESIS: A distinction was made in study design including randomised controlled trials, cohort and retrospective studies. For assessment of risk of bias, the Cochrane Handbook for Systematic Reviews of Interventions and The Risk of Bias in Non-randomized Studies - of interventions assessment tool were used. MAIN OUTCOMES: Outcome measure included in this review is endometrioma recurrence. RESULTS: We screened 5367 articles, of which ninety-seven articles were systematically reviewed and fifty-five included in this systematic review. Twelve of these were randomised controlled trials, eleven prospective cohort studies, and thirty-two retrospective studies. Nine randomised controlled trials (RCT's) were assigned as low risk of bias. For non-RCT's, only three studies had low risk of bias. Data of twenty-three studies were pooled in meta-analyses, performed for follow-up periods of 3, 6, 12 and 24 months. These studies showed a recurrence rate of 4%, 14%, 17% and 27% respectively. CONCLUSION: The meta-analysis, at 24 months after surgery the endometrioma recurrence rate showed a weighted average up to 27%. RELEVANCE: With this study, we aimed to determine the recurrence rate of endometrioma after surgical treatment in women without postoperative hormonal treatment use. Recurrence rates were up to 27%.

Comparing Methods to Determine Complete Response to Chemoradiation in Patients with Locally Advanced Cervical Cancer.

OBJECTIVES: There is no consensus on the most reliable procedure to determine remission of cervical cancer after chemoradiotherapy (CRT). Therefore, this study aims to assess the diagnostic performance of two different imaging techniques, MRI and 18F[FDG]-PET/CT, in determining the presence of locoregional residual disease after CRT in patients with locally advanced cervical cancer. METHODS: Patients diagnosed with locally advanced cervical cancer (FIGO 2009) treated with CRT were retrospectively identified from a regional cohort. The accuracy of MRI and 18F[FDG]-PET/CT in detecting locoregional residual disease was assessed with histology as the reference standard. RESULTS: The negative predictive value (NPV) and positive predictive value (PPV) for locoregional residual disease detection of MRI and 18F[FDG]-PET/CT combined were 84.2% (95% CI 73.2-92.1), and 70.4% (95% CI 51.8-85.2), respectively. The NPV and PPV of MRI alone were 80.2% (95% CI 71.2-87.5) and 47.7% (95% CI 35.8-59.7), respectively, and values of 81.1% (95% CI 72.2-88.3) and 55.8 (95% CI 42.2-68.7), respectively, were obtained for 18F[FDG]-PET/CT alone. CONCLUSION: In this study, the reliability of MRI and 18F[FDG]-PET/CT in detecting locoregional residual disease was limited. Combining MRI and 18F[FDG]-PET/CT did not improve predictive values. Routine use of both MRI and 18F[FDG]-PET/CT in the follow-up after CRT should be avoided. MRI during follow-up is the advised imaging technique. Pathology confirmation of the presence of locoregional residual disease before performing salvage surgery is warranted.