Postoperative outcomes and quality of life following hysterectomy by natural orifice transluminal endoscopic surgery (NOTES) compared to laparoscopy in women with a non-prolapsed uterus and benign gynaecological disease: a systematic review and meta-analysis.

OBJECTIVE: To critically appraise studies comparing benefits and harms in women with benign disease without prolapse undergoing hysterectomy by natural orifice transluminal endoscopic surgery (NOTES) versus laparoscopy. STUDY DESIGN: We followed the PRISMA guidelines. We searched MEDLINE, EMBASE and CENTRAL for randomised controlled trials (RCTs), controlled clinical trials (CCTs) and cohort studies comparing NOTES with laparoscopy assisted vaginal hysterectomy (LAVH) or total laparoscopic hysterectomy (TLH) in women bound to undergo removal of a non-prolapsed uterus for benign disease. Two authors searched and selected studies, extracted data and assessed the risk of bias independently. Any disagreement was resolved by discussion or arbitration. RESULTS: We did not find RCTs but retrieved two retrospective cohort studies comparing NOTES with LAVH. The study quality as assessed by the Newcastle-Ottawa scale was acceptable. Both studies reported no conversions. The operative time in women treated by NOTES was shorter compared to LAVH: the mean difference (MD) was -22.04min (95% CI -28.00min to -16.08min; 342 women; 2 studies). There were no differences for complications in women treated by NOTES compared to LAVH: the risk ratio (RR) was 0.57 (95% CI 0.17-1.91; 342 women; 2 studies). The length of stay was shorter in women treated by NOTES versus LAVH: the MD was -0.42days (95% CI -0.59days to -0.25days; 342 women; 2 studies). There were no differences for the median VAS scores at 12h between women treated by NOTES (median 2, range 0-6) or by LAVH (median 2, range 0-6) (48 women, 1 study). There were no differences in the median additional analgesic dose request in women treated by NOTES (median 0, range 0-6) or by LAVH (median 1, range 0-5) (48 women, 1 study). The hospital charges for treatment by NOTES were higher compared to LAVH: the mean difference was 137.00 € (95% CI 88.95-185.05 €; 294 women; 1 study). CONCLUSIONS: At the present NOTES should be considered as a technique under evaluation for use in gynaecological surgery. RCTs are needed to demonstrate its effectiveness.

HALON-hysterectomy by transabdominal laparoscopy or natural orifice transluminal endoscopic surgery: a randomised controlled trial (study protocol).

INTRODUCTION: Natural orifice transluminal endoscopic surgery (NOTES) uses natural body orifices to access the cavities of the human body to perform surgery. NOTES limits the magnitude of surgical trauma and has the potential to reduce postoperative pain. This is the first randomised study in women bound to undergo hysterectomy for benign gynaecological disease comparing NOTES with classical laparoscopy. METHODS AND ANALYSIS: All women aged 18-70 years, regardless of parity, consulting at our practice with an indication for hysterectomy due to benign gynaecological disease will be eligible. After stratification according to uterine size on clinical examination, participants will be randomised to be treated by laparoscopy or by transvaginal NOTES. Participants will be evaluated on day 0, days 1-7 and at 3 and 6 months. The following data will be collected: the proportion of women successfully treated by removing the uterus by the intended approach as randomised; the proportion of women admitted to the inpatient hospital; postoperative pain scores measured twice daily by the women from day 1 to 7; the total amount of analgesics used from day 1 to 7; readmission during the first 6 weeks; presence and intensity of dyspareunia and sexual well-being at baseline, 3 and 6 months (Short Sexual Functioning Scale (SSFS) scale); duration of surgery; postoperative infection or other surgical complications; direct and indirect costs incurred up to 6 weeks following surgery. The primary outcome will be the proportion of women successfully treated by the intended technique; all other outcomes are secondary. ETHICS AND DISSEMINATION: The study was approved on 1 December 2015 by the Ethics Committee of the Imelda Hospital, Bonheiden, Belgium. The first patient was randomised on 17 December 2015. The last participant randomised should be treated before 30 November 2017. The results will be presented in peer-reviewed journals and at scientific meetings within 4 years after starting recruitment. TRIAL REGISTRATION NUMBER: NCT02631837; Pre-results.