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OpenTrials
Completed

NCT Number: NCT03038945

Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure

Total laparoscopic hysterectomy is a procedure that is performed each time more often. One of the problems described for this procedure has to do with the closure of the vaginal vault, increased surgical time when suture laparoscopically, complications such as dehiscence of the dome, infections, hematomas and dyspareunia. A prospective study will be conducted to compare two different techniques for closure of the vaginal vault.

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Key information

Conditions

Gynecologic Surgical Procedures

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Claudia Lopez

Medellín, Antioquia, Colombia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients scheduled for total laparoscopic hysterectomy without other simultaneous procedures , for benign causes , who were agree to participate in the trial and give their written consent.
  • Patients ASA (American Society of Anesthesiologists) 1 and 2
  • Patients who are able to communicate by telephone and answer questions

Exclusion criteria

  • Patients with coagulation disorders, chronic use of corticosteroids, COPD (chronic obstructive pulmonary disease), collagen diseases, diabetes.
  • Endometriosis III / IV
  • Patients who can not be reached by phone

Treatment and study plan

2/0 barbed suture

Other

Close vaginal vault 2 planes with 2/0 barbed suture in patients with total laparoscopic hysterectomy in benign pathology

0/0 Vicryl suture

Other

Close vaginal vault 2 planes with 0/0 Vicryl suture in patients with total laparoscopic hysterectomy in benign pathology

Primary outcomes

  1. Cuff closure time

    Time frame: 20 minutes

    time spend for vaginal Cuff closure (in minutes)

Secondary outcomes

  1. Intra or postoperative complications

    Time frame: 10 days

    Clinical follow-up to complications during the surgery and ten days after, through questions and clinical exam.

  2. Dyspareunia

    Time frame: 12 weeks

    the visual scale was used to analyze the dyspareunia

Sponsors and collaborators

Lead sponsor

CES University

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 1, 2017
Registry last updated
Feb 24, 2017

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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