The Effect of Vertical Versus Horizontal Vaginal Cuff Closure on Vaginal Length After Laparoscopic Hysterectomy

Not Applicable

Completed

• Conditions: Hysterectomy
• Interventions: Procedure: Vaginal cuff closure - vertical; Procedure: Vaginal cuff closure - horizontal

• Registration Number: NCT02276261
• Lead Sponsor: Bridgeport Hospital

Brief Summary

This study has been designed as a prospective randomized trial to be performed at Bridgeport Hospital. Patients planning to undergo a laparoscopic or robotically assisted total laparoscopic hysterectomy with or without removal of adnexal structures will be recruited by the Bridgeport Hospital Minimally Invasive Gynecologic Surgery fellows during their preoperative office visit at the Bridgeport Hospital Gynecologic Oncology office. If enrolled, they will be assigned a sequential study identification number. During their preoperative exam, a baseline POP-Q will be performed. Demographic information will be recorded from the electronic medical record.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-28
• Study Start: 2014-11
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

• Undergoing laparoscopic or robotic-assisted laparoscopic hysterectomy
• Under the care of Dr. Dan-Arin Silasi or Dr. Masoud Azodi at Bridgeport Hospital
• Planning to follow up at the Gynecologic Oncology office at Bridgeport Hospital
• Age 18 or older
• Able to give informed consent to participate in the research study

Exclusion Criteria

• Age less than 18
• Unable to give informed consent
• Patients undergoing radical hysterectomy
• Patients receiving vaginal cuff radiation within the study period
• Patients undergoing concomitant pelvic floor or vaginal suspension procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vertical	Vaginal cuff closure - vertical	Vaginal cuff closure performed in a vertical manner.
Horizontal	Vaginal cuff closure - horizontal	Vaginal cuff closure performed in a horizontal manner.

Primary Outcome Measures

Name	Time	Method
Vaginal length	1-3 weeks postop	Vaginal length will be measured in cm by standard POP-Q measurements

Secondary Outcome Measures

Name	Time	Method
Cuff closure time	intra-op	Time will be recorded by the circulating nurse in seconds
Vaginal length	3-4 months postop	Vaginal length will be measured in cm by standard POP-Q measurements

Trial Locations

Locations (1)

Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, United States