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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03753516
• Other study ID #: WRNMMC-2017-0055
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 2020

Study information

• Verified date: May 2020
• Source: Walter Reed National Military Medical Center
• Contact: Scott Endicott, MD
• Phone: 301-400-2140
• Email: scott.p.endicott.mil[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Vaginal Cuff Dehiscence		1 year
Secondary	Vaginal Cuff Abscess		1 year
Secondary	Vaginal Cuff Cellulitis		1 year
Secondary	Vaginal Cuff bleeding		1 year