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

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Laparoscopic - Vaginal Cuff Closure; Procedure: Vaginal- Vaginal Cuff Closure

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scott Endicott, MD; Phone Number: 301-400-2140; Email: scott.p.endicott.mil@mail.mil

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Recruiting
      • Walter Reed National Military Medical Center
      • Contact: Scott Endicott, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Laparoscopic - Vaginal Cuff Closure	Procedure: Laparoscopic - 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.
ACTIVE_COMPARATOR: Vaginal - Vaginal Cuff Closure	Procedure: Vaginal- 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Vaginal Cuff Dehiscence	1 year
Vaginal Cuff Abscess	1 year
Vaginal Cuff Cellulitis	1 year
Vaginal Cuff bleeding	1 year

Collaborators and Investigators

• Sponsor: Walter Reed National Military Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (ACTUAL): November 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: WRNMMC-2017-0055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No