Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy

NCT ID: NCT02293369

Last Updated: 2016-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-11-30

Brief Summary

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American Congress of Obstetricians and Gynecologists (ACOG) advises minimally invasive methods in gynecological surgery to ensure increased benefits to the patient and reduce potential hospitalization costs.

Laparoscopic hysterectomy has become the standard approach in gynecological benign disorders. During laparoscopic hysterectomy, vaginal cuff can be closed with different sutures, techniques and approaches, which is one of the challenges of this surgery. Data is limited on potential impact of different sutures, techniques and approaches for vaginal cuff closure on female sexual function in relation to vaginal length.

Various studies in the literature evaluated different approaches (abdominal, vaginal, laparoscopic, robotic-assisted laparoscopic). In addition, for cuff closure, different techniques (interrupted, continuous) and sutures (barbed, Vicryl) were compared. Measures like operation time, cuff healing, complications, cost effectiveness, etc. were usually measured. However, there is no prospective randomized clinical study in the literature that compares laparoscopic approach with vaginal route for cuff closure in terms of female sexual function in relation to vaginal length.

Detailed Description

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Conditions

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Total Laparoscopic Hysterectomy Benign Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cuff closure via vaginal route

For vaginal cuff closure both in laparoscopic approach and vaginal route, we will use the same horizontal method, which can be described as closing the vagina anterior to posterior by leaving a horizontal scar. The repair will start at one end of the vaginal cuff, taking care to incorporate the uterosacral ligament into the initial bite and will continue toward the surgeon until the other uterosacral ligament will be incorporated into the repair, using a continuous 0-Vicryl suture in the vaginal route.

Group Type ACTIVE_COMPARATOR

Cuff closure via vaginal route

Intervention Type PROCEDURE

Vaginal cuff will be closed via vaginal route during total laparoscopic hysterectomy.

Cuff closure via laparoscopic route

For vaginal cuff closure both in laparoscopic approach and vaginal route, we will use the same horizontal method, which can be described as closing the vagina anterior to posterior by leaving a horizontal scar. In the laparoscopic approach, needles will be introduced through the umbilical trocar and removed through the peripheral trocars and intracorporeal knots will be utilized.

Group Type ACTIVE_COMPARATOR

Cuff closure via laparoscopic route

Intervention Type PROCEDURE

Vaginal cuff will be closed via laparoscopic route during total laparoscopic hysterectomy.

Interventions

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Cuff closure via vaginal route

Vaginal cuff will be closed via vaginal route during total laparoscopic hysterectomy.

Intervention Type PROCEDURE

Cuff closure via laparoscopic route

Vaginal cuff will be closed via laparoscopic route during total laparoscopic hysterectomy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled to have total laparoscopic hysterectomy because of benign conditions only

Exclusion Criteria

* Suspicion of malignancy
* Presence of large adnexal masses (maximum diameter \>10 cm at preoperative ultrasonography)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Surrey

OTHER

Sponsor Role collaborator

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Ercan Bastu

Associate Professor of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Faruk Buyru, M.D.

Role: STUDY_CHAIR

Istanbul University School of Medicine

Locations

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Department of Obstetrics and Gynecology, Istanbul University School of Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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1424

Identifier Type: -

Identifier Source: org_study_id

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