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Barbed Suture vs Smooth Suture for Vaginal Cuff Closure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01262573
Recruitment Status : Completed
First Posted : December 17, 2010
Results First Posted : May 12, 2015
Last Update Posted : January 16, 2017
Sponsor:
Information provided by (Responsible Party):
Jon I. Einarsson, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE December 15, 2010
First Posted Date  ICMJE December 17, 2010
Results First Submitted Date  ICMJE April 27, 2015
Results First Posted Date  ICMJE May 12, 2015
Last Update Posted Date January 16, 2017
Study Start Date  ICMJE December 2010
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2016)
Vaginal Cuff Closure Time [ Time Frame: During the surgical procedure ]
Average time (measured in minutes)
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2010)
Vaginal Cuff Closure Time [ Time Frame: During the surgical procedure ]
Measured in minutes
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2016)
Dyspareunia [ Time Frame: Postoperative ]
Assessed preoperatively and up to 3 months postop
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2010)
Dyspareunia [ Time Frame: Postoperative ]
Assessed preoperatively and 3 months postop
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Barbed Suture vs Smooth Suture for Vaginal Cuff Closure
Official Title  ICMJE Barbed Suture vs Smooth Suture for Vaginal Cuff Closure, a Randomized Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Closure of Vaginal Cuff at Laparoscopic Hysterectomy
Intervention  ICMJE Procedure: Closure of vaginal cuff
Closure of the vaginal cuff
Study Arms  ICMJE
  • Experimental: Barbed
    Vaginal cuff closure with barbed suture
    Intervention: Procedure: Closure of vaginal cuff
  • Active Comparator: Smooth
    Vaginal cuff closure with smooth suture
    Intervention: Procedure: Closure of vaginal cuff
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2010)
64
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients having a total laparoscopic hysterectomy for benign conditions

Exclusion Criteria:

  • Malignancy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01262573
Other Study ID Numbers  ICMJE 2010P001586
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jon I. Einarsson, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Brigham and Women's Hospital
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP