Phase 4
N=64
Barbed Suture vs Smooth Suture for Vaginal Cuff Closure
Closure of Vaginal Cuff at Laparoscopic Hysterectomy
Bottom Line
View on ClinicalTrials.gov: NCT01262573 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Vaginal Cuff Closure Time — 10.4; 9.6 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Closure of vaginal cuff (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vaginal Cuff Closure Time |
10.4; 9.6 | — |
| SECONDARY Dyspareunia |
2; 1; 1; 0; 0; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients having a total laparoscopic hysterectomy for benign conditions
Exclusion Criteria
- Malignancy
Data sourced from ClinicalTrials.gov (NCT01262573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.