Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy

Not Applicable

Completed

• Conditions: Indications for Laparoscopic Supracervical Hysterectomy
• Interventions: Device: Sealing tissue with the Enseal device; Procedure: Conventional supracervical hysterectomy

• Registration Number: NCT01806012
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

The use of the EnSeal® instrument for laparoscopic supracervical hysterectomy in a randomized, single-blinded comparison to the conventional procedure. The objective of the study is to investigate if the use of the Enseal sealing instrument for supracervical hysterectomy leads to a shortening of the operation time.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Study First Submitted: 2013-02-19
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-05
• Last Update Submitted: 2013-03-05
• Study First Posted: 2013-03-06
• Last Update Posted: 2013-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• Age >18 years
• Indication for supracervical hysterectomy without additional surgical procedures (i. e. oophorectomy)
• Willingness and capability to comply with all study tests, procedures, and assessment tools
• Capability of providing informed consent.

Exclusion Criteria

• History of, or evidence of, gynecologic malignancy within the past five years
• Pace maker, internal defibrilator/cardioconverter
• Impaired coagulation parameters
• Unwillingness to be randomized to treatment
• History of median laparotomy
• Intraabdominal adhesions
• Requirement for open laparoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enseal	Sealing tissue with the Enseal device	Tissue sealing with Enseal device
Supracervical hysterectomy using conventional instruments	Conventional supracervical hysterectomy	Supracervical hysterectomy using conventional instruments

Primary Outcome Measures

Name	Time	Method
Operation time	Day 1	The following times were documented: total operation time; T1 = start of the operation until cornual structures were ready to be dissected; T2 = the time from the first coagulation and cutting of the cornual structures until the complete preparation of each parametrial side directly before cervical detachment; T3 = time needed for the cervical detachment and subsequent steps (morcellation, closure of trocar sites) until the end of the surgical procedure.

Secondary Outcome Measures

Name	Time	Method
Post-operative pain	Day 2	Post-operative pain was documented according to a visual analog pain scale from 1 (no pain) to 10 (maximum pain) during hospital stay.
Blood loss	Day 2	The perioperative blood loss (ΔHb) was calculated using the comparison of the preoperative red blood cells (RBC) versus the RBC on the first post-operative day. The intraoperative blood loss was measured by the suction unit (categories: \< 50 ml, 50 - 100 ml, \> 100 ml) and by the number of applied blood transfusions.

Trial Locations

Locations (1)

University Women' Clinic Tübingen; 🇩🇪 Tübingen, Germany