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Completed

NCT Number: NCT05031182

Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.

During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. The surgeon will randomize the patient using RedCap computer software. The patient will then be referred either to the vNOTES group or to the laparoscopy group. The surgery will be performed by surgeons called "expert" in one of the ways first. For this, it will be necessary to have performed at least 25 hysterectomies by laparoscopy or vNOTES. The surgery will take place using the usual techniques. Per and postoperative complications will be studied and noted up to six months postoperatively.

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Key information

Conditions

Hysterectomy Laparoscopy vNOTES

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU clermont-ferrand, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult woman eligible for total hysterectomy for benign lesions with or without bilateral adnexectomy.
  • Able to give informed consent to participate in research.
  • Affiliation to a Social Security scheme.

Exclusion criteria

  • Pregnant or breastfeeding women
  • Contraindication to the laparoscopic approach
  • Contraindication to first vNOTES, in particular: virginity, history of rectal surgery, rectovaginal endometriosis, high active genital infection
  • Indications for another concomitant surgical procedure (other than procedure on the appendix)
  • Indication of hysterectomy for malignant lesion.
  • Any concomitant pathology deemed incompatible with the study.
  • COVID not cured or SARS-COv2 positivity dating less than 3 days before surgery.
  • Adult patient protected, under guardianship or curatorship or legal safeguard
  • Refusal of participation.

Treatment and study plan

Laparoscopy

Procedure

The hysterectomy is performed by laparoscopy as described in the EMC.

vNOTES

Procedure

The hysterectomy is performed by vNOTES as described Dr BAEKELANDT and this team.

Primary outcomes

  1. Complications per or post Operative

    Time frame: one month after surgery

    Appearance of a per or post operative complication: bleeding, digestive or urinary sore or infection

Secondary outcomes

  1. Measure of pain

    Time frame: Until one month

    Quantification of postoperative pain: 6 hours, 24 hours, day 2, 5, 7, 14 and at one month

  2. Duration of operation

    Time frame: one day

    From skin opening to skin or vaginal closure

  3. Assessment of quality of life

    Time frame: Six month

    Respond to SF-36 questionnaire to assess and compare quality of life before and after surgery

  4. Assessment of satisfaction

    Time frame: Six month

    Respond to FSFI questionnaire to assess and compare sexuality before and after surgery

  5. Duration of work stoppage

    Time frame: one month

    Patients will inquire if they needed to prolong the sick leave.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: VLAP

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2021
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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