Clinical trial NCT01846858: Histological Characterization of Vaginal Cuff Tissue Using Different Energy Sources During Robotic Hysterectomy
Official title: Histological Characterization of Vaginal Cuff Tissue Using Different Energy Sources During Robotic Hysterectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extent of Thermal Injury Using Different Energy Sources at the Time of Robotic Hysterectomy Procedure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for a robotic hysterectomy for benign indications

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.


Eligibility criteria: 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

Primary outcomes:
measure: Extent of thermal injust grossly from free tissue edge (mm)
timeFrame: at 12 and 6 o'clock
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Rosanne M Kho, MD
role: PRINCIPAL_INVESTIGATOR
References: