Electrosurgery Wars;Ligasure or Enseal in Total Laparoscopic Hysterectomy

February 14, 2018 updated by: Burak Karadag, MD, Antalya Training and Research Hospital

Electrosurgery Wars;Ligasure or Enseal in Total Laparoscopic Hysterectomy: A Randomised Controlled Trial

The effect of two different bipolar instruments were compared in terms of operative time, total operative time, intra-operative blood loss and intra-operative and postoperative complications. Devices included the LigaSure™ Maryland Jaw 5 mm laparoscopic instrument (LigaSure; LF 1737, Covidien, Mansfield, MA, USA) and ENSEAL™ G2 Articulating Straight 5mm Tissue Sealer (ENSEAL; NSLG2S35A, Ethicon Endo-surgery, US, LLC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a single-center, single-blinded, randomized control trial that was conducted at the University of Health Sciences Antalya Training and Research Hospital.

The study was single-blinded in that the patient was not informed of their group assignment; it is impossible to blind the surgeon using the devices.

Methods and Procedures:

Patients were recruited from outpatient clinics and informed about the study before enrollment. Women aged over 18 years scheduled for laparoscopic hysterectomy for benign indications between June 2016 and November 2017 were included in the study after obtaining written consent.

Women who had given consent were randomized one day before surgery to one of two groups:

Group 1: The Ligasure device used during the hysterectomy. Group 2: The articulating Enseal device used during the hysterectomy.

Inclusion Criteria:

  • Age 18 or older
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Under 18 years of age
  • Suspected malignancy

Surgical technique:

All laparoscopic procedures were performed under general anesthesia. An experienced surgeon, who has an experience of over 100 cases of TLH with both LigaSure and Enseal, performed all the procedures. Because both devices have long been used in the operations, they are always ready for use in our operation rooms. During the study, the first assistant was always a second or a third year assistant surgeon and the second assistant holding the uterine manipulator was a first year assistant surgeon. Operative time was recorded in minutes with a digital watch by a first year resident by dictation of the primary surgeon of the start and stop times.

After positioning the patient in lithotomy position and placement of a Foley catheter, a Rumi II (CooperSurgical, Inc, Trumbull, CT, USA) uterine manipulator with Koh cup (Bard Medical, Covington, GA, USA) of appropriate size was placed. The first assistant stood on the right side of the patient and held the camera. The second assistant held the uterine manipulator. The abdominal cavity was entered by direct trocar insertion. The site of insertion varied, being the umbilicus or Lee-Huang point, according to the size of the uterus. After pneumoperitoneum was obtained, the patient was positioned in the Trendelenburg position and three additional trocars, all 5 mm in size, were inserted from both inguinal regions and suprapubic region. Following exploration of the abdominal cavity, adhesiolysis was performed where necessary. The round ligaments were sealed and transected, the bladder peritoneum was opened, the utero-ovarian ligaments were sealed and cut, the bladder peritoneum was dissected from the vagina, the uterine vessels were skeletonized, sealed and dissected followed by sacro-uterine ligament dissection and finally the vaginal wall on the rim of the vaginal part of the uterine manipulator was cut by Harmonic AceTM. The uterus was removed vaginally in all operations but in case of large uteri, either a Chardonnen's morcellation knife (Karl Storz GmBH, Tuttlingen, Germany) or a power morcellator was used for uterine section before retrieval. The vaginal cuff was closed by laparoscopic stitching with number 1 Vicryl suture. In cases where bilateral or unilateral salpingo-oophorectomy was also indicated, the procedure was performed after removal of the uterus in order to prevent interference with operative time which was our primary outcome measure. To seal and transect uterine attachments, the LigaSure™ Maryland Jaw 5 mm laparoscopic instrument (LigaSure; LF 1737, Covidien, Mansfield, MA, USA), using the ForceTriadTM Energy Platform (Covidien, Boulder, CO, USA) was used in one group and ENSEAL™ G2 Articulating Straight 5mm Tissue Sealer (ENSEAL; NSLG2S35A, Ethicon Endo-surgery, US, LLC) using the Ethicon GEN11TM generator (Ethicon Endo-surgery, US, LLC) was used in the other group.

Follow-up was performed on postoperative day 7, and then at 1 month.Patients were also seen at our clinic if they developed symptoms between follow-up visits and complications recorded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
134

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 18 or older
  • Able and willing to provide informed consent
  • Undergoing total laparoscopic hysterectomy

Exclusion Criteria:

  • Under 18 years of age
  • Suspected malignancy

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Ligasure device
This group of women undergoing hysterectomy were randomized to the Ligasure energy device
Device: Ligasure device
Vessel-sealing device used for laparoscopic hysterectomy
Active Comparator: Articulating Enseal
This group of women undergoing hysterectomy were randomized to the articulating Enseal energy device
Device: Articulating Enseal
Vessel-sealing device used for laparoscopic hysterectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: 16 months
Defined as time from start of sealing and transection of the round ligament until start of colpotomy, was the primary endpoint.
16 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total operative time
Time Frame: 16 months
Time from placement of the first trocar until removal of all trocars
16 months
Intra-operative estimated blood loss
Time Frame: 16 months
Calculated by subtracting total volume of irrigated fluid from the amount measured in the aspiration bag after positioning the patient in reverse Trendelenburg position at the end of the operation
16 months
Intra-operative complications
Time Frame: 16 months
Visceral or vascular injury, hemorrhage, conversion to laparotomy, mechanical or functional device failure
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Antalya Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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