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

Primary Purpose

Pelvic Organ Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic - Vaginal Cuff Closure
Vaginal- Vaginal Cuff Closure
Sponsored by
Walter Reed National Military Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Walter Reed National Military Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Laparoscopic - Vaginal Cuff Closure

Vaginal - Vaginal Cuff Closure

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Vaginal Cuff Dehiscence
Vaginal Cuff Abscess
Vaginal Cuff Cellulitis
Vaginal Cuff bleeding

Full Information

First Posted
November 20, 2018
Last Updated
May 26, 2020
Sponsor
Walter Reed National Military Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03753516
Brief Title
Pelvic Floor Support After Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial Comparing Vaginal Cuff Closure Techniques
Official Title
Pelvic Floor Support After Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial Comparing Vaginal Cuff Closure Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Walter Reed National Military Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic - Vaginal Cuff Closure
Arm Type
Active Comparator
Arm Title
Vaginal - Vaginal Cuff Closure
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic - Vaginal Cuff Closure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Vaginal- Vaginal Cuff Closure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pelvic Organ Prolapse - Quantification Point C
Description
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.
Time Frame
6-8 weeks post op
Title
Pelvic Organ Prolapse - Quantification Point C
Description
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.
Time Frame
1 year post op
Secondary Outcome Measure Information:
Title
Vaginal Cuff Dehiscence
Time Frame
1 year
Title
Vaginal Cuff Abscess
Time Frame
1 year
Title
Vaginal Cuff Cellulitis
Time Frame
1 year
Title
Vaginal Cuff bleeding
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Endicott, MD
Phone
301-400-2140
Email
scott.p.endicott.mil@mail.mil
Facility Information:
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Endicott, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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