Vaginal Cuff Dehiscence and Thermal Injury During TLH

Thermal Injury Clinical Trial

Official title:

Vaginal Cuff Dehiscence and Thermal Injury at the Time of Total Laparoscopic Hysterectomy: A Review of the Duke Experience and Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080546
• Other study ID #: Pro00019452
• Status: Completed
• Phase: N/A
• First received: March 3, 2014
• Last updated: September 24, 2015
• Start date: December 2009

Study information

• Verified date: November 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Purpose of the study Part 1: Retrospective Review: The purpose of part 1 is to establish the historical rate of vaginal cuff dehiscence following total laparoscopic hysterectomy compared to total abdominal hysterectomy (TAH), total vaginal hysterectomy (TVH), radical hysterectomy (RH) and laparoscopic-assisted vaginal hysterectomy (LAVH) at Duke University Medical Center.

Part 2: Prospective Randomized Controlled Trial: The purpose of part 2 is to determine if the mode of electrothermal colpotomy incision affects (1) the degree of thermal injury at the time of laparoscopic hysterectomy or (2) the incidence of clinical surrogates of compromised vaginal cuff healing. Women already scheduled for TLH will be randomized to colpotomy incision with the V mode or standard cut/coag form of electrothermal energy.

Prevalence of vaginal cuff injury will be calculated, and cross tabulation tables will be used to examine the association fo dehiscence with proposed risk factors in the retrospective part of the study. In the randomized controlled trial, depth of thermal injury will be compared between the two groups, and a chi-square test will be used to test for a difference in clinical outcomes between the two groups. There is little risk associated with this study above the normal surgical risks; however, the V mode has not been previously been studied for its use in making a colpotomy incision. Loss of confidentiality is a risk of the study, but all samples will be de-identified and given a unique study number, and only individuals directly involved in the study will be given access to the study information.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years

2. Patient scheduled for total laparoscopic hysterectomy (TLH)

3. Signed informed consent

Exclusion Criteria:

1. Known pelvic infection within 30 days prior to hysterectomy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thermal Injury
• Vaginal Cuff Dehiscence

Intervention

Procedure:
• Cut-Coag
Incision using electrothermal cautery, with an attempt made to use the "cut" (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the "coag" (pulsed high-voltage, low-current) mode.
• V-mode
Incision using electrothermal cautery in the "V mode". The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.

Device:
• Valleylab G3000 Electrosurgical Device
Use of surgical device Valleylab G3000 Electrosurgical Device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of thermal injury at the time of laparoscopic hysterectomy	distance in millimeters over which thermal tissue injury extends (henceforth referred to as "injury").	after slide preparation, each specimen is reviewed twice within 36 months of surgery	Yes
Secondary	incidence of clinical surrogates of compromised vaginal cuff healing	a difference between arms in the proportion of patients who have at least one of the following post-operatively: vaginal vault granulation tissue, vaginal cuff separation/dehiscence, or vaginal apex infection	4 weeks, 3 months, and 6 months after hysterectomy for a post-operative check and pelvic examination	Yes