Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Retrospective Review of Enseal Laparoscopic Vaginal Assisted Hysterectomy (LAVH) Versus Traditional LAVH

NCT01217866

Benign Uterine Disease

COMPLETED

Electrosurgery Wars;Ligasure or Enseal in Total Laparoscopic Hysterectomy

NCT03433209

Task Performance

COMPLETED NA

Study of Conventional Laparoscopic Hysterectomy Versus Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution

NCT01581905

Menorrhagia Dysfunctional Uterine Bleeding Leiomyoma +2 more

TERMINATED NA

Impact of a Minimally Invasive Approach to Laparoscopic Hysterectomy on Postoperative Recovery

NCT05102032

Uterus Disease

UNKNOWN NA

Minimally Invasive Benign Hysterectomy

NCT01865929

Menorrhagia Metrorrhagia Uterine Fibroids +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Indications for Laparoscopic Supracervical Hysterectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Enseal

Tissue sealing with Enseal device

Group Type EXPERIMENTAL

Sealing tissue with the Enseal device

Intervention Type DEVICE

Supracervical hysterectomy using conventional instruments

Group Type ACTIVE_COMPARATOR

Conventional supracervical hysterectomy

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sealing tissue with the Enseal device

Intervention Type DEVICE

Conventional supracervical hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No