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

NCT02197728 | Completed

• 1 other identifier: 13-326
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Hysterectomy for Benign Conditions

Keywords

hysterectomy, uterine manipulator, thermal damage, laparoscopy, colpotomy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Blood Loss

  45 minutes to 3 hours

• Pain

  24h post surgery

• Manipulator Installment

  intraoperative

Study Arms (2)

Hohl uterine manipulator ®

ACTIVE COMPARATOR

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

Colpo-Probe™ Vaginal Fornix Delineator

ACTIVE COMPARATOR

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

Interventions

Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy DEVICE

Colpo-Probe™ Vaginal Fornix Delineator; Hohl uterine manipulator ®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael´s Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Study Officials

• Guylaine Lefebvre, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: July 23, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 22, 2019

Record last verified: 2019-02

Locations

CA (1)