Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy

University Hospital Tuebingen

Status: Completed

Conditions: Indications for Laparoscopic Supracervical Hysterectomy

Treatments: Procedure: Conventional supracervical hysterectomy; Device: Sealing tissue with the Enseal device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01806012

05022013

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Enseal

Experimental group

Description:

Tissue sealing with Enseal device

Treatment:

Device: Sealing tissue with the Enseal device

Supracervical hysterectomy using conventional instruments

Active Comparator group

Description:

Supracervical hysterectomy using conventional instruments

Treatment:

Procedure: Conventional supracervical hysterectomy