Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy

Study Overview
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Brief Summary
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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.

Official Title
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Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy: a Randomized, Single-Blinded Study Comparing the Efficacy to the Routine Procedure

Conditions
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Indications for Laparoscopic Supracervical Hysterectomy

Intervention / Treatment
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* Device: Sealing tissue with the Enseal device
* Procedure: Conventional supracervical hysterectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enseal<br>Tissue sealing with Enseal device | Device: Sealing tissue with the Enseal device<br> <br> |
| Active Comparator: Supracervical hysterectomy using conventional instruments<br>Supracervical hysterectomy using conventional instruments | Procedure: Conventional supracervical hysterectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | 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. | Day 2 | 
| Post-operative pain | Post-operative pain was documented according to a visual analog pain scale from 1 (no pain) to 10 (maximum pain) during hospital stay. | Day 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supracervical Hysterectomy, Leiomyomas, Adenomyosis