Barbed Suture vs Smooth Suture for Vaginal Cuff Closure

NCT ID: NCT01262573

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-11-30

Brief Summary

This study compares outcomes among patients having a total laparoscopic hysterectomy. This involves removing the uterus and cervix using a laparoscopic or keyhole technique. The top of the vagina is routinely sutured closed after this procedure and this study is comparing two different suture materials for this purpose. One suture material is a barbed suture that has the advantage of maintaining good tension and closure on the wound. The other is a standard smooth suture that is commonly used for this procedure. The investigators are comparing the time it takes to close the vaginal cuff, as well as bleeding after surgery and the healing of the top of the vagina.

Detailed Description

Barbed suture has been used to close the vaginal vault for almost 3 years now, and a few preliminary studies report positive outcomes. Unfortunately, the retrospective nature of these studies may present outcomes in an overly positive light, since some of the patients may not be able to remember all the potential complications or problems they may have had in the immediate postoperative period (recall bias). The current standard of care for vaginal cuff closure appears to be to use Vicryl suture although practices vary widely.

The specific aim of this study is to evaluate whether the use of barbed suture facilitates the laparoscopic closure of the vaginal cuff during a total laparoscopic hysterectomy.

The inclusion criteria for our study include all patients who are planned for a total laparoscopic hysterectomy due to benign conditions such as symptomatic uterine fibroids, abnormal uterine bleeding, endometriosis and pelvic pain.

The laparoscopic hysterectomy will proceed as per routine. For vaginal cuff closure with barbed suture we will use a 0 polydioxanone (PDO) bidirectional barbed suture on a 36 mm half-circle taper point needle. For cuff closure with Vicryl, we plan to use 2/0 Vicryl with the vaginal cuff closure proceeding in a similar fashion as with the barbed suture. Regardless of suture material used it is important to obtain a full thickness bite with a 1 cm margin on the vagina mucosa on each bite.

Patients will be stratified to either closure by the attending or the resident or fellow under the supervision of the attending. The resident or fellow will have 15 minutes to complete the vaginal cuff closure. If they are not able to complete it within that time frame, the attending will take over and complete the vaginal cuff closure. This is to avoid adding excess operating time to the procedure due to having a trainee performing a portion of the procedure. Patients will also be asked to complete a short survey regarding dyspareunia as well as a standardized sexual function questionnaire (FSFI) prior to surgery and 3 months after surgery to evaluate if the use of barbed suture affects this in any way. Further we will also inquire about male dyspareunia before and after surgery for the same reason.

Patients will be examined at a postoperative visit 3 weeks after surgery and vaginal cuff granulation and any evidence of vaginal cuff infection or separation will be carefully examined and documented. Patients will be called 3 months after surgery to inquire about any dyspareunia, male dyspareunia, vaginal bleeding or readmissions to the hospital. We are interested in evaluating dyspareunia, since a concern has been raised that the use of barbed suture at the vaginal apex may result in dyspareunia and partner dyspareunia. Although we have not found this to be the case in our clinical experience we would like to evaluate this point, especially since the use of barbed suture for closing the vaginal cuff has become a common practice nationwide. Patients will be dismissed from the trial after the 3 month follow up.

Conditions

Closure of Vaginal Cuff at Laparoscopic Hysterectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Barbed

Vaginal cuff closure with barbed suture

Group Type: EXPERIMENTAL

Closure of vaginal cuff

Intervention Type: PROCEDURE

Closure of the vaginal cuff

Smooth

Vaginal cuff closure with smooth suture

Group Type: ACTIVE_COMPARATOR

Closure of vaginal cuff

Intervention Type: PROCEDURE

Closure of the vaginal cuff

Interventions

Closure of vaginal cuff

Closure of the vaginal cuff

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients having a total laparoscopic hysterectomy for benign conditions

Exclusion Criteria

• Malignancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jon I. Einarsson

Chief, Division of Minimally Invasive Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2010P001586

Identifier Type: -

Identifier Source: org_study_id