- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01262573
Barbed Suture vs Smooth Suture for Vaginal Cuff Closure
Barbed Suture vs Smooth Suture for Vaginal Cuff Closure, a Randomized Trial
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients having a total laparoscopic hysterectomy for benign conditions
Exclusion Criteria:
- Malignancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Barbed
Vaginal cuff closure with barbed suture
|
Closure of the vaginal cuff
|
Active Comparator: Smooth
Vaginal cuff closure with smooth suture
|
Closure of the vaginal cuff
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vaginal Cuff Closure Time
Time Frame: During the surgical procedure
|
Average time (measured in minutes)
|
During the surgical procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspareunia
Time Frame: Postoperative
|
Assessed preoperatively and up to 3 months postop
|
Postoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2010P001586
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Closure of Vaginal Cuff at Laparoscopic Hysterectomy
-
Heracure Medical Ltd.RecruitingVaginal or Laparoscopic HysterectomyIsrael
-
The Cleveland ClinicRecruitingVaginal Hysterectomy | Laparoscopic Supracervical HysterectomyUnited States
-
Ethicon, Inc.CompletedBariatric - Sleeve Gastrectomy Staple Line Reinforcement | Gynecology - Vaginal Cuff ClosureItaly, United States, Germany
-
Unity Health TorontoUniversity of TorontoCompletedEvaluation of Laparoscopic Hysterectomy SimulatorUnited States, Canada, Netherlands
-
Spital Limmattal SchlierenUniversity of ZurichTerminatedVaginal Infection | Laparoscopic HysterectomySwitzerland
-
University of LouisvilleKARL STORZ Endoscopy-America, Inc.CompletedFistula | Pelvic Organ Prolapse | Incontinence | Prolapse of Vaginal Vault After Hysterectomy | Bulging of Vaginal WallUnited States
-
Chinese University of Hong KongCompletedLaparoscopic Suturing | Surgical Suturing for Closure of Gastrotomy | Robotic Surgical SuturingChina
-
Kaiser PermanenteMassachusetts General HospitalUnknownProlapse of Vaginal Vault After HysterectomyUnited States
-
Mayo ClinicCompletedExtent of Thermal Injury Using Different Energy Sources at the Time of Robotic Hysterectomy ProcedureUnited States
-
Federal University of São PauloUnknownUterovaginal Prolapse | Prolapse of Vaginal Vault After Hysterectomy | Complete Tear, Sacrospinous Ligament | Uterosacral Ligament; RuptureBrazil
Clinical Trials on Closure of vaginal cuff
-
Walter Reed National Military Medical CenterUnknown
-
Bridgeport HospitalCompleted
-
Cairo UniversityUnknown
-
Istanbul UniversityUniversity of SurreyCompletedTotal Laparoscopic Hysterectomy | Benign ConditionsTurkey
-
Aesculap AGB.Braun Surgical SARecruitingCervical Cancer | Endometriosis | Ovarian Cancer | Fallopian Tube Cancer | Endometrial Cancer | Uterine Prolapse | Uterine Cancer | Abnormal Uterine BleedingGermany, Spain
-
Ethicon, Inc.CompletedBariatric - Sleeve Gastrectomy Staple Line Reinforcement | Gynecology - Vaginal Cuff ClosureItaly, United States, Germany
-
Mansoura UniversityRecruitingUterine DiseasesEgypt
-
El-Galaa Military Medical ComplexCompletedVaginal Infection | Vaginal Cuff Dehiscence | Vaginal HematomaEgypt
-
Brigham and Women's HospitalWithdrawnPain | Dyspareunia | Surgical Mesh
-
Milton S. Hershey Medical CenterCompletedHysterectomyUnited States