Hysterectomy by Transabdominal Laparoscopy or NOTES

NCT02631837 | Completed Results DMC

• 1 other identifier: B689201526261
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To randomly compare hysterectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) versus laparoscopy uterus in women with benign gynecological pathology. Study design: Randomized controlled/single center/single-blinded/parallel-group/non-inferiority/efficacy trial. Study population: All women aged 18 to 70 years regardless of parity with a non-prolapsed uterus and a benign indication for hysterectomy. Primary study outcome parameters: successful removal of the uterus by the intended technique. Secondary outcomes: the proportion of women admitted to the in-hospital ward; postoperative pain scores; the total amount of analgesics used; postoperative infection; per- or postoperative complications; hospital readmission rates; duration of the surgical procedure; incidence and intensity of dyspareunia; sexual wellbeing; health-related quality of life; costs.

Conditions

Uterine Diseases

Keywords

NOTES; Laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Successful Removal of the Uterus Without Conversion to Another Technique

  Successful removal of the uterus without conversion to another technique with or without morcellation

  Intraoperative

Secondary Outcomes (16)

• Admission in Hospital for at Least One Night Observation

  Measured on the day of the surgical intervention

• Postoperative Pain Scores

  The first seven days after the surgical intervention

• The Use of Analgetic Drugs for Postoperative Pain

  The first week after the surgical intervention

• Postoperative Infection

  The first six weeks after the surgical intervention

• Intra- Operative Complications

  At the time of the surgical intervention

Study Arms (2)

vNOTES hysterectomy

EXPERIMENTAL

vaginal Natural Orifice Transluminal Endoscopic Surgery

Procedure: vNOTES hysterectomy

LSC hysterectomy

ACTIVE COMPARATOR

Laparoscopic hysterectomy

Procedure: LSC hysterectomy

Interventions

vNOTES hysterectomy PROCEDURE

Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy

vNOTES hysterectomy

LSC hysterectomy PROCEDURE

Surgical removal of the uterus by transabdominal laparoscopy

LSC hysterectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All women aged 18 to 70 years regardless of parity, with a non-prolapsed uterus in need of a hysterectomy for benign indication
• Written informed consent obtained prior to surgery

You may not qualify if:

• History of rectal surgery
• Suspected rectovaginal endometriosis
• Suspected malignancy
• History of pelvic inflammatory disease, especially prior tubo-ovarian or pouch of Douglas abscess
• Active lower genital tract infection e.g. Chlamydia, N. gonorrhoeae
• Virgo
• Pregnancy
• Failure to provide written informed consent prior to surgery

Sponsors & Collaborators

• Imelda Hospital, Bonheiden: lead

Study Sites (1)

Imelda Hospital

Bonheiden, Antwerp, 2820, Belgium

Location

Related Publications (10)

• Reynders A, Baekelandt J. Adnexectomy by Poor Man's Transvaginal NOTES. Gynecol Surg 2015; 12: 207-11

  BACKGROUND

• Van Peer S, Baekelandt J. Natural orifice transluminal endoscopic surgery (NOTES) salpingectomy for ectopic pregnancy: a first series demonstrating how a new surgical technique can be applied in a low-resource setting. Gynecol Surg 2015; 12: 299-302

  BACKGROUND

• Baekelandt J, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol BW, Bosteels JJ. HALON-hysterectomy by transabdominal laparoscopy or natural orifice transluminal endoscopic surgery: a randomised controlled trial (study protocol). BMJ Open. 2016 Aug 12;6(8):e011546. doi: 10.1136/bmjopen-2016-011546.

  PMID: 27519922 BACKGROUND

• Baekelandt JF, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol B, Bosteels J. Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial. BJOG. 2019 Jan;126(1):105-113. doi: 10.1111/1471-0528.15504.

  PMID: 30325565 BACKGROUND

• Su H, Yen CF, Wu KY, Han CM, Lee CL. Hysterectomy via transvaginal natural orifice transluminal endoscopic surgery (NOTES): feasibility of an innovative approach. Taiwan J Obstet Gynecol. 2012 Jun;51(2):217-21. doi: 10.1016/j.tjog.2012.04.009.

  PMID: 22795097 RESULT

• Lee CL, Wu KY, Su H, Wu PJ, Han CM, Yen CF. Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (NOTES): a series of 137 patients. J Minim Invasive Gynecol. 2014 Sep-Oct;21(5):818-24. doi: 10.1016/j.jmig.2014.03.011. Epub 2014 Mar 25.

  PMID: 24681063 RESULT

• Atallah S, Martin-Perez B, Albert M, Schoonyoung H, Quinteros F, Hunter L, Larach S. Vaginal Access Minimally Invasive Surgery (VAMIS): A New Approach to Hysterectomy. Surg Innov. 2015 Aug;22(4):344-7. doi: 10.1177/1553350614560273. Epub 2014 Nov 27.

  PMID: 25432882 RESULT

• Yang YS, Kim SY, Hur MH, Oh KY. Natural orifice transluminal endoscopic surgery-assisted versus single-port laparoscopic-assisted vaginal hysterectomy: a case-matched study. J Minim Invasive Gynecol. 2014 Jul-Aug;21(4):624-31. doi: 10.1016/j.jmig.2014.01.005. Epub 2014 Jan 21.

  PMID: 24462594 RESULT

• Wang CJ, Huang HY, Huang CY, Su H. Hysterectomy via transvaginal natural orifice transluminal endoscopic surgery for nonprolapsed uteri. Surg Endosc. 2015 Jan;29(1):100-7. doi: 10.1007/s00464-014-3639-y. Epub 2014 Oct 1.

  PMID: 25270610 RESULT

• Baekelandt J. Total Vaginal NOTES Hysterectomy: A New Approach to Hysterectomy. J Minim Invasive Gynecol. 2015 Sep-Oct;22(6):1088-94. doi: 10.1016/j.jmig.2015.05.015. Epub 2015 May 22.

  PMID: 26009278 RESULT

MeSH Terms

Conditions

Uterine Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Limitations and Caveats

Data on sexual well-being will be analysed at a later date. We received the 6 month study questionnaire of the last recruited participant A53 on 15-07-2017. We noted this date as the actual study completion date in the trial register. Although the secondary outcomes at 6 months of this last patient were received one month earlier due to the very timely sending of the questionnaire by our study secretary we decided to consider them as valid, since only secondary outcomes were collected.

Results Point of Contact

• Title: Dr Jan Baekelandt
• Organization: Imelda ziekenhuis Bonheiden

jan.baekelandt@imelda.be

+ 32 15 505208

Study Officials

• Jan Baekelandt, MD

  Imelda Hospital, Bonheiden

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 16, 2015
• Study Start: December 1, 2015
• Primary Completion: February 24, 2017
• Study Completion: July 15, 2017
• Last Updated: April 11, 2023
• Results First Posted: June 11, 2020

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)