Completed

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

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What is being tested

Sealing tissue with the Enseal device

+ Conventional supracervical hysterectomy

DeviceProcedure
Who is being recruted

Urogenital Diseases+9

+ Genital Diseases

+ Female Urogenital Diseases and Pregnancy Complications

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2010
See protocol details

Summary

Principal SponsorUniversity Hospital Tuebingen
Last updated: March 6, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2010

Actual date on which the first participant was enrolled.

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.

NCT01806012
Principal SponsorUniversity Hospital Tuebingen
Last updated: March 6, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleNeoplasmsNeoplasms by Histologic TypeNeoplasms, Muscle TissueUterine DiseasesNeoplasms, Connective and Soft TissueFemale Urogenital DiseasesLeiomyomaAdenomyosis

Criteria

4 inclusion criteria required to participate
Age > 18 years
Capability of providing informed consent
Indication for supracervical hysterectomy without additional surgical procedures (i. e. oophorectomy)
Willingness and capability to comply with all study tests, procedures, and assessment tools
7 exclusion criteria prevent from participating
History of median laparotomy
History of, or evidence of, gynecologic malignancy within the past five years
Impaired coagulation parameters
Intraabdominal adhesions
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Tissue sealing with Enseal device

Group II

Active Comparator
Supracervical hysterectomy using conventional instruments

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University Women' Clinic Tübingen

Tübingen, GermanyOpen University Women' Clinic Tübingen in Google Maps
CompletedOne Study Center