Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy: a Randomized, Single-Blinded Study Comparing the Efficacy to the Routine Procedure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Operation time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Enseal
Tissue sealing with Enseal device
Intervention: Sealing tissue with the Enseal device (Device)
Supracervical hysterectomy using conventional instruments
Supracervical hysterectomy using conventional instruments
Intervention: Conventional supracervical hysterectomy (Procedure)
Outcomes
Primary Outcomes
Operation time
Time Frame: 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 Outcomes
- Post-operative pain(Day 2)
- Blood loss(Day 2)
Investigators
Bernhard Kraemer
Principal Investigator
University Hospital Tuebingen