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

Laparoscopic Hysterectomy for Benign Conditions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197728
• Other study ID #: 13-326
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2019
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Hysterectomy for Benign Conditions

Intervention

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

Locations

Country	Name	City	State
Canada	St. Michael´s Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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