Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy

Istanbul University

Status: Completed

Conditions: Total Laparoscopic Hysterectomy; Benign Conditions

Treatments: Procedure: Cuff closure via vaginal route; Procedure: Cuff closure via laparoscopic route

Study type: Interventional

Funder types: Other

Identifiers

NCT02293369

1424

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: Female

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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58 participants in 2 patient groups

Cuff closure via vaginal route

Active Comparator group

Description:

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.

Treatment:

Procedure: Cuff closure via vaginal route

Cuff closure via laparoscopic route

Active Comparator group

Description:

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.

Treatment:

Procedure: Cuff closure via laparoscopic route