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

NCT ID: NCT02197728

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hohl uterine manipulator ®

Total laparoscopic hysterectomy is performed using the Hohl uterine manipulator ®

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Colpo-Probe™ Vaginal Fornix Delineator

Total laparoscopic hysterectomy is performed using the Colpo-Probe™ Vaginal Fornix Delineator

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guylaine Lefebvre, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Michael´s Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

13-326

Identifier Type: -

Identifier Source: org_study_id