Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure

Study Overview
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Brief Summary
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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.

Official Title
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Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure

Conditions
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Gynecologic Surgical Procedures

Intervention / Treatment
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* Other: 2/0 barbed suture
* Other: 0/0 Vicryl suture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2/0 barbed suture<br>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<br>* Close vaginal vault 2 planes with 2/0 barbed suture in patients with total laparoscopic hysterectomy in benign pathology<br>|
| Active Comparator: Vicryl suture<br>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<br>* Close vaginal vault 2 planes with 0/0 Vicryl suture in patients with total laparoscopic hysterectomy in benign pathology<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra or postoperative complications | Clinical follow-up to complications during the surgery and ten days after, through questions and clinical exam. | 10 days | 
| Dyspareunia | the visual scale was used to analyze the dyspareunia | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Hysterectomy, Suture Techniques