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CompletedNCT02276261Updated Jul 20, 2016

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

An interventional study of Vaginal cuff closure - vertical and Vaginal cuff closure - horizontal in Hysterectomy, sponsored by Bridgeport Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-20.

Sponsored by Bridgeport Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Hysterectomy
03

In context

Lead sponsor

Bridgeport Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Vertical

    Vaginal cuff closure performed in a vertical manner.

    Procedure: Vaginal cuff closure - vertical

  • Active comparator
    Horizontal

    Vaginal cuff closure performed in a horizontal manner.

    Procedure: Vaginal cuff closure - horizontal

Interventions

  • ProcedureVaginal cuff closure - vertical

    Vaginal cuff is closed vertically.

  • ProcedureVaginal cuff closure - horizontal

    Vaginal cuff is closed horizontally.

06

What researchers measure

Primary outcomes

  1. Vaginal length

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

    Time frame: 1-3 weeks postop

Secondary outcomes

  1. Vaginal length

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

    Time frame: 3-4 months postop

  2. Cuff closure time

    Time will be recorded by the circulating nurse in seconds

    Time frame: intra-op

Other outcomes

  1. Complications

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

    Time frame: Up to 4 months post-op

07

Study locations

1 site
  • Bridgeport Hospital
    Bridgeport, Connecticut 06610, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02276261
Lead sponsor
Bridgeport Hospital
Responsible party
Amanda Tower (Fellow, Bridgeport Hospital) — Principal investigator
First posted
Oct 28, 2014
Start date
Nov 2014
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Jul 20, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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