Comparing Two Devices of Uterine Manipulation and Vaginal Fornix Delineation at Total Laparoscopic Hysterectomy

We hypothesize, that the use of the Hohl manipulator® at total laparoscopic hysterectomy reduces operative time (from skin incision to detachment of the uterus) and lateral termal damage of the vaginal wall during colpotomy due to the following reasons: (1) Uterine manipulation is better with the Hohl manipulator®, thereby facilitating dissection during all aspects of the surgery, (2) more tension can be applied on the vagina during colpotomy, thereby hastening electrosurgical transection, reducing activation time and reduce lateral thermal damage and (3) tension on the vagina can be applied until the colpotomy is finished, due to the tight connection between the Hohl manipulator® and the cervix of the uterus, which also affects speed of transection, electrosurgical device activation time and lateral thermal damage.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Hysterectomy for Benign Conditions
• Intervention / Treatment: Device: Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael´s Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All women aged over 18 years, scheduled for a laparoscopic hysterectomy for a benign disorder will be asked to participate and included after written informed consent.

Exclusion Criteria:

• pregnancy
• malignancy
• if uterine size exceeds 20 weeks of gestation
• or if the uterus could be removed by a vaginal approach

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hohl uterine manipulator ®; Total laparoscopic hysterectomy is performed using the Hohl uterine manipulator ®	Device: Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy
Active Comparator: Colpo-Probe™ Vaginal Fornix Delineator; Total laparoscopic hysterectomy is performed using the Colpo-Probe™ Vaginal Fornix Delineator	Device: Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detachment of the uterus	Operative time from skin incision to detachment of uterus. Times are routinely collected by operating room nursing staff.	45 minutes to 3 hours
Thermal Damage	Lateral thermal damage to the vagina will be measured on the specimen (in mm) at the time of pathologic evaluation.	2 weeks post surgery
Colpotomy	Time from first monopolar energy activation to completion of colpotomy. Operative times are routinely collected by operating room nursing staff.	3 minutes to 20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Loss	Total amount of blood lost throughout surgery. Measured in cc.	45 minutes to 3 hours
Pain	Amount of post operative pain measured using a pain sensitivity scale.	24h post surgery
Manipulator Installment		intraoperative

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Guylaine Lefebvre, MD, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 23, 2014
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (Estimate): July 23, 2014

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: hysterectomy, uterine manipulator, thermal damage, laparoscopy, colpotomy
• Other Study ID Numbers: 13-326