Notes Adnexectomy for Benign Pathology Compared to Laparoscopic Excision

NCT02630329 | Completed DMC

• 1 other identifier: B689201526268
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To compare vNOTES (vaginal Natural Orifice Transluminal Endoscopic Surgery) and established laparoscopic removal of benign adnexal masses Study design: Randomized controlled/single center/single-blinded/parallel-group/non-inferiority/efficacy trial. Study population: Women aged 18 to 70 years with symptomatic or persistent benign adnexal masses detected by clinical examination and ultrasound. Randomization: Women will be randomly allocated to undergo one of two techniques for removal of the benign adnexal mass immediately before surgery by using a computer generated randomization list. The investigators will use stratified randomization according to the cyst diameter. Intervention: Women will be treated by a surgeon who is not blinded to the treatment allocation and who is equally skilled in performing both techniques. In the intervention group a vNOTES technique will be used. Control: In the control group surgery will be done by a classical laparoscopic technique. Participants, nursing staff and outcome assessors will be blinded. Main study parameters/endpoints: Primary outcomes: successful removal of a benign adnexal mass without spill. Secondary outcomes: the proportion of women discharged the same day based on their own preference; postoperative pain scores using a VAS (Visual Analogue Scale) measured between day 1 till 7 by the participating women following surgery and the total amount of analgesics used as described in the standardized pain treatment protocol between day 1 till 7; postoperative infection defined by lower abdominal pain with fever \> 38°C and positive clinical signs or laboratory findings; per- or postoperative complications according to the Clavien- Dindo classification detected during the first six weeks of surgery; duration of the surgical procedure; incidence and intensity of dyspareunia recorded by the participants at 3 and 6 months by self-reporting using a simple questionnaire and VAS scale; sexual wellbeing recorded by the participants at 3 and 6 months by SSFS (Short Sexual Functioning Scale); direct costs associated up to 6 weeks after the surgical intervention with both procedures.

Conditions

Natural Orifice Endoscopic Surgery; Disease, Adnexal; Laparoscopic Surgery

Keywords

NOTES; Benign adnexal disease; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Successful removal of adnexal mass without spill

  The proportion of women successfully treated by removing the adnexal mass without spill, using a dichotomous outcome measure, will be used as a measure of efficacy.

  Intraoperative

Secondary Outcomes (11)

• Discharge from the hospital the day of the surgical intervention

  Dichotomous outcome measured on the day of the surgical intervention

• Postoperative pain scores

  The first week after the surgical intervention

• The use of analgesics for postoperative pain

  The first week after the surgical intervention

• Postoperative infection

  The first six weeks after the surgical intervention

• Complications

  The first six weeks after the surgical intervention

Study Arms (2)

vNOTES adnexectomy

EXPERIMENTAL

Vaginal Natural Orifice Transluminal Endoscopic Surgery

Procedure: vNOTES adnexectomy

LSC adnexectomy

ACTIVE COMPARATOR

Laparoscopic adnexectomy

Procedure: Laparoscopic adnexectomy

Interventions

vNOTES adnexectomy PROCEDURE

Surgical removal of one or both adnexa by a natural orifice transluminal endoscopic surgical technique using a colpotomy (transvaginal incision)

vNOTES adnexectomy

Laparoscopic adnexectomy PROCEDURE

Surgical removal of one or both adnexa by transabdominal laparoscopy

LSC adnexectomy

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 symptomatic adnexal mass presumed to be benign based on ultrasound examination by applying the IOTA simple rules
• All women aged 18 to 70 years regardless of parity with an asymptomatic persistent adnexal mass presumed to be benign based on ultrasound examination by applying the IOTA simple rules
• Written informed consent obtained prior to surgery

You may not qualify if:

• History of hysterectomy by any technique
• History of rectal surgery
• Suspected rectovaginal endometriosis
• Suspected endometriotic cyst
• Solid adnexal mass
• High suspicion of adnexal malignancy based on clinical, ultrasound or biochemical findings
• 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
• Need for other uterine surgical intervention (i.e. endometrial ablation, resection, myomectomy or hysterectomy)
• Additional pathology necessitating hysterectomy
• 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 (6)

• Wang PH, Lee WL, Juang CM, Tsai WY, Chao HT, Yuan CC. Excision of mature teratoma using culdotomy, with and without laparoscopy: a prospective randomised trial. BJOG. 2001 Jan;108(1):91-4. doi: 10.1111/j.1471-0528.2001.00003.x.

  PMID: 11213011 BACKGROUND

• Baekelandt J. Poor man's NOTES: can it be a good approach for adhesiolysis? A first case report with video demonstration. J Minim Invasive Gynecol. 2015 Mar-Apr;22(3):319. doi: 10.1016/j.jmig.2014.11.001. Epub 2014 Nov 10.

  PMID: 25460516 RESULT

• Yang YS, Hur MH, Oh KY, Kim SY. Transvaginal natural orifice transluminal endoscopic surgery for adnexal masses. J Obstet Gynaecol Res. 2013 Dec;39(12):1604-9. doi: 10.1111/jog.12108. Epub 2013 Jul 22.

  PMID: 23875997 RESULT

• Ghezzi F, Cromi A, Uccella S, Bogani G, Serati M, Bolis P. Transumbilical versus transvaginal retrieval of surgical specimens at laparoscopy: a randomized trial. Am J Obstet Gynecol. 2012 Aug;207(2):112.e1-6. doi: 10.1016/j.ajog.2012.05.016. Epub 2012 May 23.

  PMID: 22704765 RESULT

• Medeiros LR, Rosa DD, Bozzetti MC, Fachel JM, Furness S, Garry R, Rosa MI, Stein AT. Laparoscopy versus laparotomy for benign ovarian tumour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD004751. doi: 10.1002/14651858.CD004751.pub3.

  PMID: 19370607 RESULT

• Baekelandt JF, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol BWJ, Bosteels JJA. Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) adnexectomy for benign pathology compared with laparoscopic excision (NOTABLE): a protocol for a randomised controlled trial. BMJ Open. 2018 Jan 10;8(1):e018059. doi: 10.1136/bmjopen-2017-018059.

  PMID: 29326183 DERIVED

MeSH Terms

Conditions

Adnexal Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Jan Baekelandt, MD

  Imelda Hospital, Bonheiden

  PRINCIPAL INVESTIGATOR

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 8, 2015
• First Posted: December 15, 2015
• Study Start: February 3, 2016
• Primary Completion: April 16, 2020
• Study Completion: April 16, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)