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

Hysterectomy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02276261
• Other study ID #: 111401
• Status: Completed
• Phase: N/A
• First received: October 20, 2014
• Last updated: July 18, 2016
• Start date: November 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Bridgeport Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Procedure:
• Vaginal cuff closure - vertical
Vaginal cuff is closed vertically.
• Vaginal cuff closure - horizontal
Vaginal cuff is closed horizontally.

Locations

Country	Name	City	State
United States	Bridgeport Hospital	Bridgeport	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Bridgeport Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	Including urinary retention, bladder injury, ureteral injury, cuff dehiscence, cuff bleeding requiring further procedures or cauterization	Up to 4 months post-op	Yes
Primary	Vaginal length	Vaginal length will be measured in cm by standard POP-Q measurements	1-3 weeks postop	No
Secondary	Vaginal length	Vaginal length will be measured in cm by standard POP-Q measurements	3-4 months postop	No
Secondary	Cuff closure time	Time will be recorded by the circulating nurse in seconds	intra-op	No