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

ABSTRACT: 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.

SUBMITTER: Baekelandt J

PROVIDER: S-EPMC4985989 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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

Baekelandt Jan J De Mulder Peter A PA Le Roy Ilse I Mathieu Chantal C Laenen Annouschka A Enzlin Paul P Weyers Steven S Mol Ben Wj BW Bosteels Jan Ja JJ

BMJ open 20160812 8

<h4>Introduction</h4>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.<h4>Methods and analysis</h4>All women aged 18-70 years, regardless of parity, consult ...[more]

PMID: 27519922

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Project description:Objective: To evaluate feasibility and safety of hysterectomy and adnexal procedures by vaginal natural orifice transluminal endoscopic surgery (vNOTES). Study Design: This is a prospective observational study at a tertiary center and teaching University hospital. We enrolled prospectively 34 patients with benign diseases sequentially. Results: We measured baseline characteristics, surgical data, and pain score (VAS) after surgery. We surveyed before/after surgery. The time of port installation and each stage of surgery was measured. The learning curve was assessed through the graph according to the number of operations using linear and logarithmic regression curve estimation. The complications of surgery were investigated. The median age of the patients was 47.5 years (38-73). Median BMI was 22.4 (18.2-30.0). 20 cases of leiomyoma, four cases of adenomyosis, three cases of uterine prolapse, four cases of endometrial hyperplasia, and three cases of CIN were diagnosed. The median uterine weight was 180.0 g. The median port-installation time was 15.0 min (range, 4-35 min) and median total operation time was 85.5 min (range 43.0-132.0). Complications occurred in three patients. Two cases of bladder injury happened during vesicovaginal space dissection before the installation of the Wound Retractor (WR). One patient underwent transumbilical single-port surgery because of late-onset postoperative bleeding on the 13th postoperative day. The mean postoperative VAS scores were 3.36 immediately after surgery and 3.06, 2.79, and 2.45 at 6, 12, and 24 h after surgery, respectively. In continuous variable analysis, we detected a correlation between port-installation time and postoperative VAS ≥4 (pain score as need for medication). Based on a learning curve, port-installation time and total operation time appeared to reach the proficiency level by the 10th case. Conclusions: Although there were three complications, vNOTES offers advantages to patients and surgeons. More surgical techniques will be developed in vNOTES.

Dataset Information

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

Publications

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

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