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

NCT03753516 — Not applicable, Terminated, 58 participants, Walter Reed National Military Medical Center
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RegistryNCT03753516
StatusTerminated - Difficulty with follow up 2/2 COVID-19 Pandemic
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment58 (Actual)
SponsorWalter Reed National Military Medical Center (Fed)
ConditionsPelvic Organ Prolapse
InterventionsLaparoscopic - Vaginal Cuff Closure, Vaginal- Vaginal Cuff Closure (Procedure)
Datesstart 2017-07-01, primary completion 2020-12-30, completion 2020-12-30, first posted 2018-11-27, last updated 2024-10-15
Locations1 site in United States

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Laparoscopic - Vaginal Cuff ClosureActive comparatorProcedure: Laparoscopic - Vaginal Cuff Closure
Vaginal - Vaginal Cuff ClosureActive comparatorProcedure: Vaginal- Vaginal Cuff Closure
  • 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.
  • 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.

+Outcome measures

Primary outcomes

  • Pelvic Organ Prolapse - Quantification Point C [6-8 weeks post op]: 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 [1 year post op]: 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 outcomes

  • Vaginal Cuff Dehiscence [1 year]
  • Vaginal Cuff Abscess [1 year]
  • Vaginal Cuff Cellulitis [1 year]
  • Vaginal Cuff bleeding [1 year]

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Walter Reed National Military Medical CenterBethesda, MarylandUnited States

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