Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure

February 23, 2017 updated by: Claudia López, CES University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Claudia Lopez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2/0 barbed suture
Use barbed suture for the closure of the vaginal vault in patients with total Laparoscopic hysterectomy caused by a benign gynecologist pathology
Other: 2/0 barbed suture
Close vaginal vault 2 planes with 2/0 barbed suture in patients with total laparoscopic hysterectomy in benign pathology
Active Comparator: Vicryl suture
Use VICRYL suture for the closure of the vaginal vault in patients with total Laparoscopic hysterectomy caused by a benign gynecologist pathology
Other: 0/0 Vicryl suture
Close vaginal vault 2 planes with 0/0 Vicryl suture in patients with total laparoscopic hysterectomy in benign pathology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cuff closure time
Time Frame: 20 minutes
time spend for vaginal Cuff closure (in minutes)
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 days
Dyspareunia
Time Frame: 12 weeks
the visual scale was used to analyze the dyspareunia
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CES University

Investigators

  • Principal Investigator: CLAUDIA LOPEZ, Gynecologist, Clinica del Prado

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

January 19, 2017

First Submitted That Met QC Criteria

January 31, 2017

First Posted (Estimate)

February 1, 2017

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 377

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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