Trial Outcomes & Findings for Barbed Suture vs Smooth Suture for Vaginal Cuff Closure (NCT NCT01262573)
NCT ID: NCT01262573
Last Updated: 2017-01-16
Results Overview
Average time (measured in minutes)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
64 participants
Primary outcome timeframe
During the surgical procedure
Results posted on
2017-01-16
Participant Flow
Participant milestones
| Measure |
Barbed
Vaginal cuff closure with barbed suture
Closure of vaginal cuff: Closure of the vaginal cuff
|
Smooth
Vaginal cuff closure with smooth suture
Closure of vaginal cuff: Closure of the vaginal cuff
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Barbed
Vaginal cuff closure with barbed suture
Closure of vaginal cuff: Closure of the vaginal cuff
|
Smooth
Vaginal cuff closure with smooth suture
Closure of vaginal cuff: Closure of the vaginal cuff
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Barbed Suture vs Smooth Suture for Vaginal Cuff Closure
Baseline characteristics by cohort
| Measure |
Barbed
n=32 Participants
Vaginal cuff closure with barbed suture
Closure of vaginal cuff: Closure of the vaginal cuff
|
Smooth
n=31 Participants
Vaginal cuff closure with smooth suture
Closure of vaginal cuff: Closure of the vaginal cuff
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.1 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 0.71 • n=5 Participants
|
|
Gender
Female
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
31 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
BMI
|
29.1 kg/m^2
STANDARD_DEVIATION 5.9 • n=5 Participants
|
26.9 kg/m^2
STANDARD_DEVIATION 8.6 • n=7 Participants
|
28.0 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Parity
|
1.7 Births
STANDARD_DEVIATION 1.3 • n=5 Participants
|
1.7 Births
STANDARD_DEVIATION 1.0 • n=7 Participants
|
1.7 Births
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Smoking Status - Smoker
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Marital Status - Married
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Hospital
Brigham and Women's Hospital
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Hospital
Faulkner Hospital
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Hospital
Army Hospital
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Cuff closure performed by the Attending Surgeon or the Fellow/Resident
Attending
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Cuff closure performed by the Attending Surgeon or the Fellow/Resident
Fellow/Resident
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Medical History
Fibroids
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Medical History
Pelvic Pain
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Medical History
Infertility
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Medical History
Prolapse
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Medical History
Abnormal Uterine Bleeding
|
27 participants
n=5 Participants
|
24 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Medical History
Prior Laparoscopy
|
15 participants
n=5 Participants
|
12 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Medical History
Prior Laparotomy
|
12 participants
n=5 Participants
|
19 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Sexual Function
Any female dyspareunia reported
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Sexual Function
Any male dyspareunia reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Sexual Function
Ongoing problem
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Sexual Function
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the surgical procedureAverage time (measured in minutes)
Outcome measures
| Measure |
Barbed
n=32 Participants
Vaginal cuff closure with barbed suture
Closure of vaginal cuff: Closure of the vaginal cuff
|
Smooth
n=31 Participants
Vaginal cuff closure with smooth suture
Closure of vaginal cuff: Closure of the vaginal cuff
|
|---|---|---|
|
Vaginal Cuff Closure Time
|
10.4 minutes
Standard Deviation 5.2
|
9.6 minutes
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: PostoperativeAssessed preoperatively and up to 3 months postop
Outcome measures
| Measure |
Barbed
n=32 Participants
Vaginal cuff closure with barbed suture
Closure of vaginal cuff: Closure of the vaginal cuff
|
Smooth
n=31 Participants
Vaginal cuff closure with smooth suture
Closure of vaginal cuff: Closure of the vaginal cuff
|
|---|---|---|
|
Dyspareunia
Any female dyspareunia reported
|
2 participants
|
1 participants
|
|
Dyspareunia
Any male dyspareunia reported
|
1 participants
|
0 participants
|
|
Dyspareunia
Ongoing problem
|
0 participants
|
1 participants
|
|
Dyspareunia
Other
|
3 participants
|
0 participants
|
Adverse Events
Barbed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Smooth
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place