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

B

Bridgeport Hospital

Status

Completed

Conditions

Hysterectomy

Treatments

Procedure: Vaginal cuff closure - horizontal
Procedure: Vaginal cuff closure - vertical

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

43 participants in 2 patient groups

Vertical
Experimental group
Description:
Vaginal cuff closure performed in a vertical manner.
Treatment:
Procedure: Vaginal cuff closure - vertical
Horizontal
Active Comparator group
Description:
Vaginal cuff closure performed in a horizontal manner.
Treatment:
Procedure: Vaginal cuff closure - horizontal

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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