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Completed

NCT Number: NCT02276261

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

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.

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Key information

Conditions

Hysterectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal cuff closure - vertical

Procedure

Vaginal cuff is closed vertically.

Vaginal cuff closure - horizontal

Procedure

Vaginal cuff is closed horizontally.

Primary outcomes

  1. Vaginal length

    Time frame: 1-3 weeks postop

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

Secondary outcomes

  1. Vaginal length

    Time frame: 3-4 months postop

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

  2. Cuff closure time

    Time frame: intra-op

    Time will be recorded by the circulating nurse in seconds

Other outcomes

  1. Complications

    Time frame: Up to 4 months post-op

    Including urinary retention, bladder injury, ureteral injury, cuff dehiscence, cuff bleeding requiring further procedures or cauterization

Sponsors and collaborators

Lead sponsor

Bridgeport Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 28, 2014
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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