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

Not Applicable

Completed

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

• Registration Number: NCT02197728
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-05-23
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-23
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 91

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colpo-Probe™ Vaginal Fornix Delineator	Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy	Total laparoscopic hysterectomy is performed using the Colpo-Probe™ Vaginal Fornix Delineator
Hohl uterine manipulator ®	Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy	Total laparoscopic hysterectomy is performed using the Hohl uterine manipulator ®

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Michael´s Hospital; 🇨🇦 Toronto, Ontario, Canada