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Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure

C

CES University

Status

Completed

Conditions

Gynecologic Surgical Procedures

Treatments

Other: 2/0 barbed suture
Other: 0/0 Vicryl suture

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 2 patient groups

2/0 barbed suture
Experimental group
Description:
Use barbed suture for the closure of the vaginal vault in patients with total Laparoscopic hysterectomy caused by a benign gynecologist pathology
Treatment:
Other: 2/0 barbed suture
Vicryl suture
Active Comparator group
Description:
Use VICRYL suture for the closure of the vaginal vault in patients with total Laparoscopic hysterectomy caused by a benign gynecologist pathology
Treatment:
Other: 0/0 Vicryl suture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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