Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure

CES University150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Gynecologic Surgical Procedures

Interventions

2/0 barbed sutureOTHER

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

0/0 Vicryl sutureOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Claudia Lopez

Medellín, Antioquia, Colombia

Outcomes

Primary Outcomes

Cuff closure time

time spend for vaginal Cuff closure (in minutes)

Time frame: 20 minutes

Secondary Outcomes

Intra or postoperative complications

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

Time frame: 10 days

Dyspareunia

the visual scale was used to analyze the dyspareunia

Time frame: 12 weeks

Data from ClinicalTrials.gov

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