Vaginal Cuff Dehiscence and Thermal Injury During TLH

NCT02080546 | Completed Results

• 1 other identifier: Pro00019452
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose of this randomized control study 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.

Conditions

Vaginal Cuff Dehiscence; Thermal Injury

Keywords

Vaginal cuff dehiscence; Thermal Injury; Total laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (1)

• Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy

  distance in millimeters over which thermal tissue injury extends (henceforth referred to as "injury").

  up to 36 months

Secondary Outcomes (1)

• Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing

  4 weeks, 3 months, and 6 months after hysterectomy for a post-operative check and pelvic examination

Study Arms (2)

Cut/Coag

ACTIVE COMPARATOR

Procedure: Cut-Coag; Device: Valleylab G3000 Electrosurgical Device

V-mode

EXPERIMENTAL

Procedure: V-mode; Device: Valleylab G3000 Electrosurgical Device

Interventions

Cut-Coag PROCEDURE

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.

Also known as: Valleylab G3000 Electrosurgical Device

Cut/Coag

V-mode PROCEDURE

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.

Also known as: Valleylab G3000 Electrosurgical Device

V-mode

Valleylab G3000 Electrosurgical Device DEVICE

Use of surgical device Valleylab G3000 Electrosurgical Device

Cut/Coag; V-mode

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Patient scheduled for total laparoscopic hysterectomy (TLH)
• Signed informed consent

You may not qualify if:

• \. Known pelvic infection within 30 days prior to hysterectomy

Sponsors & Collaborators

• Duke University: lead

Related Publications (1)

• Teoh D, Lowery WJ, Jiang X, Ehrisman J, Halvorson P, Broadwater G, Bentley R, Secord AA, Sobolewski C, Berchuck A, Havrilesky LJ, Valea FA, Lee PS. Vaginal cuff thermal injury by mode of colpotomy at total laparoscopic hysterectomy: a randomized clinical trial. J Minim Invasive Gynecol. 2015 Feb;22(2):227-33. doi: 10.1016/j.jmig.2014.10.002. Epub 2014 Oct 8.

  PMID: 25305572 DERIVED

Results Point of Contact

• Title: Dr Paula S Lee
• Organization: Duke University Medical Center

paula.s.lee@duke.edu

919-684-3765

Study Officials

• Paula S Lee, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 6, 2014
• Study Start: December 1, 2009
• Primary Completion: February 1, 2014
• Last Updated: June 3, 2016
• Results First Posted: June 3, 2016

Record last verified: 2016-01