title: Vaginal cuff thermal injury by mode of colpotomy at total laparoscopic hysterectomy: a randomized clinical trial.
abstract: OBJECTIVE
  To evaluate if the use of Valleylab mode ("V mode") (Covidien, Mansfield, MA) electrothermal energy for colpotomy during total laparoscopic hysterectomy (LH) results in a smaller margin of thermal injury to the upper vagina compared with traditional cut/coagulate (cut/coag) electrothermal energy.
  
  
  METHODS
  Prospective randomized clinical trial (Canadian Task Force classification I).
  
  
  METHODS
  University medical center.
  
  
  METHODS
  A total of 101 subjects who underwent LH between June 2010 and August 2012.
  
  
  METHODS
  Subjects were randomized to colpotomy by V mode electrothermal energy or cut/coag electrothermal energy.
  
  
  RESULTS
  The primary end point was the median depth of thermal injury measured in millimeters. The secondary end points included the proportion of subjects who developed granulation tissue, induration, infection, or dehiscence at the vaginal cuff at 4 weeks, 3 months, or 6 months postoperatively. There was no significant difference in the median depth of thermal injury in the cut/coag and V mode arms (anterior margin: 0.68 mm vs 0.63 mm [p = .94], posterior margin: 0.66 mm vs 0.70 mm [p = .87], respectively). Twenty-seven percent of subjects in each arm developed at least 1 of the clinical end points at 4 weeks, 3 months, or 6 months postoperatively (granulation tissue: 6%-18% vs 8%-21%, induration: 0%-2% vs 4%-5%, infection: 0%-4% vs 0%-10%, dehiscence: 2% vs 0% in the cut/coag and V mode arms, respectively), with no difference between arms (p = 1.0).
  
  
  CONCLUSIONS
  The V mode does not reduce the depth of thermal injury compared with cut/coag electrothermal energy when used for colpotomy incision during total laparoscopic hysterectomy (Clinical Trials.gov ID: NCT02080546).
authors.affiliation: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Duke University, Durham, North Carolina. Electronic address: dkteoh@umn.edu.
authors.forename: Deanna
authors.initials: D
authors.lastname: Teoh
authors.affiliation: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Duke University, Durham, North Carolina.
authors.forename: William J
authors.initials: WJ
authors.lastname: Lowery
authors.affiliation: Department of Pathology, Duke University, Durham, North Carolina.
authors.forename: Xiaoyin
authors.initials: X
authors.lastname: Jiang
authors.affiliation: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Duke University, Durham, North Carolina.
authors.forename: Jessie
authors.initials: J
authors.lastname: Ehrisman
authors.affiliation: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Duke University, Durham, North Carolina.
authors.forename: Paige
authors.initials: P
authors.lastname: Halvorson
authors.affiliation: Cancer Institute Biostatistics, Duke University, Durham, North Carolina.
authors.forename: Gloria
authors.initials: G
authors.lastname: Broadwater
authors.affiliation: Department of Pathology, Duke University, Durham, North Carolina.
authors.forename: Rex
authors.initials: R
authors.lastname: Bentley
authors.affiliation: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Duke University, Durham, North Carolina.
authors.forename: Angeles Alvarez
authors.initials: AA
authors.lastname: Secord
authors.affiliation: Department of Obstetrics and Gynecology, Division of Minimally Invasive Gynecologic Surgery, Duke University, Durham, North Carolina.
authors.forename: Craig
authors.initials: C
authors.lastname: Sobolewski
authors.affiliation: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Duke University, Durham, North Carolina.
authors.forename: Andrew
authors.initials: A
authors.lastname: Berchuck
authors.affiliation: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Duke University, Durham, North Carolina.
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Havrilesky
authors.affiliation: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Duke University, Durham, North Carolina.
authors.forename: Fidel A
authors.initials: FA
authors.lastname: Valea
authors.affiliation: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Duke University, Durham, North Carolina.
authors.forename: Paula S
authors.initials: PS
authors.lastname: Lee
mesh_terms: D020884:Colpotomy; D004598:Electrosurgery / Q000009:adverse effects*; D016889:Endometrial Neoplasms / Q000473:pathology* / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007045:Hysterectomy, Vaginal / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods; D010535:Laparoscopy / Q000379:methods; D008875:Middle Aged; D009367:Neoplasm Staging; D011183:Postoperative Complications / Q000209:etiology; D011247:Pregnancy; D011446:Prospective Studies; D016896:Treatment Outcome; D014621:Vagina / Q000293:injuries* / Q000473:pathology / Q000601:surgery
keywords: Electrothermal injury; Total laparoscopic hysterectomy; Vaginal cuff dehiscence