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

NCT03753516 | Terminated DMC

• 1 other identifier: WRNMMC-2017-0055
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (2)

• Pelvic Organ Prolapse - Quantification Point C

  The 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.

  6-8 weeks post op

• Pelvic Organ Prolapse - Quantification Point C

  The Pelvic Organ Prolapse - Quantification system is a validated way to measure pelvic organ prolapse. The investigators will measure this post op at 1 year to see if prolapse is better using one method vs the other.

  1 year post op

Secondary Outcomes (4)

• Vaginal Cuff Dehiscence

  1 year

• Vaginal Cuff Abscess

  1 year

• Vaginal Cuff Cellulitis

  1 year

• Vaginal Cuff bleeding

  1 year

Study Arms (2)

Laparoscopic - Vaginal Cuff Closure

ACTIVE COMPARATOR

Procedure: Laparoscopic - Vaginal Cuff Closure

Vaginal - Vaginal Cuff Closure

ACTIVE COMPARATOR

Procedure: Vaginal- Vaginal Cuff Closure

Interventions

Laparoscopic - Vaginal Cuff Closure PROCEDURE

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.

Laparoscopic - Vaginal Cuff Closure

Vaginal- Vaginal Cuff Closure PROCEDURE

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.

Vaginal - Vaginal Cuff Closure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 27, 2018
• Study Start: July 1, 2017
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)