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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01846858
Collaborator
(none)
31
1
16
1.9

Study Details

Study Description

Brief 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 laser at the time of the colpotomy.

Study Design

Study Type:
Observational
Actual Enrollment :
31 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Histological Characterization of Vaginal Cuff Tissue Using Different Energy Sources During Robotic Hysterectomy
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
CO2 Laser

Monopolar energy

Outcome Measures

Primary Outcome Measures

  1. Extent of thermal injust grossly from free tissue edge (mm) [at 12 and 6 o'clock]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Female

  • Patient over age of 18 years undergoing a robotic total hysterectomy

  • Patients in Mayo Clinic (Arizona)

Exclusion Criteria:
  • Patients with gynecologic malignancy involving the vagina

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Arizona Phoenix Arizona United States 50854

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Rosanne M Kho, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rosanne M. Kho, M.D., Associate Professor of Obstetrics-Gynecology, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01846858
Other Study ID Numbers:
  • 10-001538
First Posted:
May 3, 2013
Last Update Posted:
Dec 19, 2014
Last Verified:
Dec 1, 2014

Study Results

No Results Posted as of Dec 19, 2014