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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02276261
Other study ID # 111401
Secondary ID
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


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
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