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OpenTrials
Completed

NCT Number: NCT02197728

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael´s Hospital

Toronto, Ontario, M5B 1W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Primary outcomes

  1. Detachment of the uterus

    Time frame: 45 minutes to 3 hours

    Operative time from skin incision to detachment of uterus. Times are routinely collected by operating room nursing staff.

  2. Thermal Damage

    Time frame: 2 weeks post surgery

    Lateral thermal damage to the vagina will be measured on the specimen (in mm) at the time of pathologic evaluation.

  3. Colpotomy

    Time frame: 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.

Secondary outcomes

  1. Blood Loss

    Time frame: 45 minutes to 3 hours

    Total amount of blood lost throughout surgery. Measured in cc.

  2. Pain

    Time frame: 24h post surgery

    Amount of post operative pain measured using a pain sensitivity scale.

  3. Manipulator Installment

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 23, 2014
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.