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NCT01846858 · ClinicalTrials.gov registry record

Histological Characterization of Vaginal Cuff Tissue Using Different Energy Sources During Robotic Hysterectomy

A clinical trial, sponsored by Mayo Clinic.

Completed
Registry status
31
Enrollment target

NCT01846858: Completed study, sponsored by Mayo Clinic.

NCT01846858 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 31 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01846858 has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
31 participants
Enrollment target

Study Summary

Vaginal cuff dehiscence, a rare complication of gynecologic surgeries, can be devastating, particularly when associated with bowel evisceration. A review of records from 1970 - 2001 at the Mayo Clinic in Rochester, MN revealed a low incidence (0.032%) of vaginal cuff dehiscence after pelvic operation via both abdominal and vaginal approaches3. At a single, large, tertiary care facility, total laparoscopic hysterectomy (TLH) was associated with an increased incidence of vaginal cuff dehiscence compared to other approaches (4.93% vs. 0.29% TVH, and 0.12% TAH)1. A review of our robotic experience revealed a vaginal cuff dehiscence incidence of 4.1%, which is comparable to the previously reported incidence for TLH2. An increasing number of laparoscopic hysterectomies are being performed in the United States with the rate of laparoscopic procedures increasing from 0.3% in 1990 to 11.8% in 20034. With 11.8% of 600,000 annual hysterectomies being performed via the laparoscopic route in the United States, there would be an estimated 3,400 cases of vaginal cuff dehiscence per year. The cause of the higher rate of vaginal cuff dehiscence in both laparoscopic and robotic hysterectomies is currently unknown. One of the major differences between the laparoscopic and robotic approach as compared to the vaginal/abdominal route is the method by which the cervix is amputated from the vagina. With the vaginal and abdominal approaches, a colpotomy is made sharply with a knife or scissors. In contrast, the colpotomy is performed with electrocoagulation with the laparoscopic and robotic routes. One theory to explain the increased dehiscence incidence is the lateral thermal effects of electrocoagulation on the vaginal cuff which may adversely affect tissue healing. This study aims primarily to shed light on the etiology of vaginal cuff healing after a robotic total hysterectomy. This will be done by comparing the extent of thermal injury at the cellular level using monopolar vs CO2 las

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2013-04
Est. Completion 2014-08
Mayo Clinic

2,844 total trials

What the finished NCT01846858 record still lists

NCT01846858 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 31 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01846858 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01846858 about?

NCT01846858 is a clinical study titled "Histological Characterization of Vaginal Cuff Tissue Using Different Energy Sources During Robotic Hysterectomy". Vaginal cuff dehiscence, a rare complication of gynecologic surgeries, can be devastating, particularly when associated with bowel evisceration. A review of records from 1970 - 2001 at the Mayo Clinic in Rochester, MN revealed a low incidence (0.032%) of vaginal cuff dehiscence after pelvic operatio...

What is the current status of trial NCT01846858?

This trial is currently completed. The enrollment target is 31 participants. The study started on 2013-04. Estimated completion is 2014-08.

Who is sponsoring clinical trial NCT01846858?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01846858, the US trial registry maintained by the National Library of Medicine. NCT01846858 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.