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Obstetrics and gynaecology
Protocol
HALON—hysterectomy by transabdominal laparoscopy or natural orifice transluminal endoscopic surgery: a randomised controlled trial (study protocol)
  1. Jan Baekelandt1,
  2. Peter A De Mulder2,
  3. Ilse Le Roy2,
  4. Chantal Mathieu3,
  5. Annouschka Laenen4,
  6. Paul Enzlin5,
  7. Steven Weyers6,
  8. Ben WJ Mol7,
  9. Jan JA Bosteels1,8
  1. 1Department of Gynaecology, Imelda Hospital, Bonheiden, Belgium
  2. 2Department of Anaesthesiology, Imelda Hospital, Bonheiden, Belgium
  3. 3Clinical and Experimental Endocrinology, UZ Gasthuisberg, Leuven, Belgium
  4. 4Leuven Biostatistics and Statistical Bioinformatics Centre (L-BioStat), Leuven, Belgium
  5. 5Department of Neuroscience, Interfaculty Institute for Family and Sexuality Studies, KU Leuven, Leuven, Belgium
  6. 6Universitaire Vrouwenkliniek, University Hospital Gent, Gent, Belgium
  7. 7The Robinson Institute, School of Paediatrics and Reproductive Health, The University of Adelaide, North Adelaide, Australia
  8. 8CEBAM, The Centre for Evidence-based Medicine, Cochrane Belgium, Academic Centre for General Practice, Leuven, Belgium
  1. Correspondence to Dr Jan J A Bosteels; Jan.bosteels{at}hotmail.com

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.

  • NOTES
  • Hysterectomy

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-011546

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