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

NCT02276261 | Completed

• 1 other identifier: 111401
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Hysterectomy

Outcome Measures

Primary Outcomes (1)

• Vaginal length

  Vaginal length will be measured in cm by standard POP-Q measurements

  1-3 weeks postop

Secondary Outcomes (2)

• Vaginal length

  3-4 months postop

• Cuff closure time

  intra-op

Other Outcomes (1)

• Complications

  Up to 4 months post-op

Study Arms (2)

Vertical

EXPERIMENTAL

Vaginal cuff closure performed in a vertical manner.

Procedure: Vaginal cuff closure - vertical

Horizontal

ACTIVE COMPARATOR

Vaginal cuff closure performed in a horizontal manner.

Procedure: Vaginal cuff closure - horizontal

Interventions

Vaginal cuff closure - vertical PROCEDURE

Vaginal cuff is closed vertically.

Vertical

Vaginal cuff closure - horizontal PROCEDURE

Vaginal cuff is closed horizontally.

Horizontal

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bridgeport Hospital: lead

Study Sites (1)

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 28, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

US (1)