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Pelvic Floor Support After Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial Comparing Vaginal Cuff Closure Techniques

Pelvic Floor Support After Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial Comparing Vaginal Cuff Closure Techniques

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03753516
Enrollment
58
Registered
2018-11-27
Start date
2017-07-01
Completion date
2020-12-30
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Brief summary

The purpose of this study is to learn about the effect of different vaginal cuff closure techniques on pelvic support after laparoscopic hysterectomy and robotic assisted laparoscopic hysterectomy for benign gynecologic conditions.

Interventions

PROCEDURELaparoscopic - Vaginal Cuff Closure

All participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close laparoscopically using an 0-Barbed suture.

PROCEDUREVaginal- Vaginal Cuff Closure

All participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close vaginally using an 0-Vicryl suture in a vertical fashion.

Sponsors

Walter Reed National Military Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Women over 18 years of age undergoing total laparoscopic hysterectomy and robotic assisted total laparoscopic hysterectomy for benign disease. * Subjects must be able to self-consent. * Department of Defense beneficiary

Exclusion criteria

* Patients will be excluded if they undergo a concurrent procedure for prolapse. * If the indication for the procedure is a malignancy. * Those that plan to leave the area in less than 1 year will not be included. * Pop-Q Point C of \>-4

Design outcomes

Primary

MeasureTime frameDescription
Pelvic Organ Prolapse - Quantification Point C6-8 weeks post opThe Pelvic Organ Prolapse - Quantification system is a validated way to measure pelvic organ prolapse. The investigators will measure this post op at 6-8 weeks to see if prolapse is better using one method vs the other.

Secondary

MeasureTime frame
Vaginal Cuff Dehiscence1 year
Vaginal Cuff Abscess1 year
Vaginal Cuff Cellulitis1 year
Vaginal Cuff bleeding1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026