Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Closure of Vaginal Cuff at Laparoscopic Hysterectomy
Intervention Procedure: Closure of vaginal cuff
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Barbed Smooth
Hide Arm/Group Description

Vaginal cuff closure with barbed suture

Closure of vaginal cuff: Closure of the vaginal cuff

Vaginal cuff closure with smooth suture

Closure of vaginal cuff: Closure of the vaginal cuff

Period Title: Overall Study
Started 32 32
Completed 32 31
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Barbed Smooth Total
Hide Arm/Group Description

Vaginal cuff closure with barbed suture

Closure of vaginal cuff: Closure of the vaginal cuff

Vaginal cuff closure with smooth suture

Closure of vaginal cuff: Closure of the vaginal cuff

Total of all reporting groups
Overall Number of Baseline Participants 32 31 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 31 participants 63 participants
46.1  (5.6) 43.2  (8.1) 44.7  (0.71)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 31 participants 63 participants
Female
32
 100.0%
31
 100.0%
63
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 31 participants 63 participants
White 19 19 38
Black 8 8 16
Hispanic 2 2 4
Asian 2 1 3
Other 0 1 1
Unknown 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 31 participants 63 participants
32 31 63
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 32 participants 31 participants 63 participants
29.1  (5.9) 26.9  (8.6) 28.0  (4.2)
Parity  
Mean (Standard Deviation)
Unit of measure:  Births
Number Analyzed 32 participants 31 participants 63 participants
1.7  (1.3) 1.7  (1.0) 1.7  (0)
Smoking Status - Smoker  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 31 participants 63 participants
2 7 9
Marital Status - Married  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 31 participants 63 participants
11 12 23
Hospital  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 31 participants 63 participants
Brigham and Women's Hospital 11 11 22
Faulkner Hospital 7 7 14
Army Hospital 14 13 27
Cuff closure performed by the Attending Surgeon or the Fellow/Resident  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 31 participants 63 participants
Attending 16 15 31
Fellow/Resident 16 16 32
Medical History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 31 participants 63 participants
Fibroids 21 20 41
Pelvic Pain 23 24 47
Infertility 3 2 5
Prolapse 0 0 0
Abnormal Uterine Bleeding 27 24 51
Prior Laparoscopy 15 12 27
Prior Laparotomy 12 19 31
Sexual Function  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 31 participants 63 participants
Any female dyspareunia reported 12 13 25
Any male dyspareunia reported 0 0 0
Ongoing problem 5 0 5
Other 0 0 0
1.Primary Outcome
Title Vaginal Cuff Closure Time
Hide Description Average time (measured in minutes)
Time Frame During the surgical procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Barbed Smooth
Hide Arm/Group Description:

Vaginal cuff closure with barbed suture

Closure of vaginal cuff: Closure of the vaginal cuff

Vaginal cuff closure with smooth suture

Closure of vaginal cuff: Closure of the vaginal cuff

Overall Number of Participants Analyzed 32 31
Mean (Standard Deviation)
Unit of Measure: minutes
10.4  (5.2) 9.6  (4.8)
2.Secondary Outcome
Title Dyspareunia
Hide Description Assessed preoperatively and up to 3 months postop
Time Frame Postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Barbed Smooth
Hide Arm/Group Description:

Vaginal cuff closure with barbed suture

Closure of vaginal cuff: Closure of the vaginal cuff

Vaginal cuff closure with smooth suture

Closure of vaginal cuff: Closure of the vaginal cuff

Overall Number of Participants Analyzed 32 31
Measure Type: Number
Unit of Measure: participants
Any female dyspareunia reported 2 1
Any male dyspareunia reported 1 0
Ongoing problem 0 1
Other 3 0
Time Frame Adverse event data was collected for 3 months after surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Barbed Smooth
Hide Arm/Group Description

Vaginal cuff closure with barbed suture

Closure of vaginal cuff: Closure of the vaginal cuff

Vaginal cuff closure with smooth suture

Closure of vaginal cuff: Closure of the vaginal cuff

All-Cause Mortality
Barbed Smooth
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Barbed Smooth
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/31 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Barbed Smooth
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/31 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jon Einarsson
Organization: Brigham and Women's Hospital
Phone: 617-525-8582
EMail: jeinarsson@partners.org
Layout table for additonal information
Responsible Party: Jon I. Einarsson, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01262573    
Other Study ID Numbers: 2010P001586
First Submitted: December 15, 2010
First Posted: December 17, 2010
Results First Submitted: April 27, 2015
Results First Posted: May 12, 2015
Last Update Posted: January 16, 2017