Clinical trial NCT03038945: Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure
Official title: Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Surgical Procedures
Keywords: Laparoscopy
Hysterectomy
Suture Techniques
Lead sponsor: CES University
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cuff closure time
timeFrame: 20 minutes
Secondary outcomes:
measure: Intra or postoperative complications
timeFrame: 10 days
measure: Dyspareunia
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Claudia Lopez
state: Antioquia
Study officials:
affiliation: CLINICA DEL PRADO
name: CLAUDIA LOPEZ, Gynecologist
role: PRINCIPAL_INVESTIGATOR
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