Comparison of Postoperative Outcome of Hepatectomy for Living Donors According to Three Different Incision

July 23, 2019 updated by: Gaab Soo Kim, Samsung Medical Center

Comparison of Postoperative Outcome of Hepatectomy for Living Donors According to Three Different Incision: Conventional Incision vs Minimal Incision vs Transverse Incision Assisted by Laparoscopy

Living donor liver transplantation (LDLT) is an important option for patients with end-stage liver disease requiring liver transplantation. When performing LDLT, the safety and well being of donors is of the utmost importance. The conventional incision for donor hepatectomy is a right subcostal incision with a midline extension up to xiphoid. Minimally invasive liver surgery throughout a single 10 cm upper midline incision without laparoscopic assistance has been widely applied and considered to be safe and effective. Recently, laparoscopic and minimally invasive living donor hepatectomy via transverse incision has been suggested to reduce morbidity and the invasiveness of living donor hepatectomy. Although minimally invasive approach has become the surgical method of choice for many transplant centers, little data on comparing the impact of all three different type incision in living liver donors. In our center, the investigators have adopted three different incision according to surgical teams. The investigators undertook this study with the aims of comparing the pain and quality of life of donors according to type of three different incisions and assessing any benefits to the donor due to the smaller midline incision during the early postoperative period.

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.

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.
Observational

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.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study was a single center, non-randomized, observational comparative analysis of 3 different surgical technique. The living liver donors underwent hepatectomy using three different type of incisions; 1) right subcostal incision with a midline extension 2) upper midline incision without laparoscopic assistance 3) transverse incision with laparosocpic assistance

Description

Inclusion Criteria:

  • ASA (American Society of Anesthesiologists) physical status I-II,
  • adult undergoing hepatectomy for living donors

Exclusion Criteria:

  • known allergy to any of the drugs used in this study,
  • bleeding diathesis,
  • neurologic dysfunction (preexisting lower limb neurological deficit),
  • recent systemic or local infections,
  • history of drug use, or
  • under treatment with opioids because of chronic pain

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
CI (conventional incision)
The living liver donors underwent hepatectomy using right subcostal incision with a midline extension (conventional incision)
Procedure: hepatectomy conventional incision
This study was a single center, nonrandomized, observational comparative analysis of 3 different surgical technique. Three surgical teams operated alternately at our center, and donors undergoing hepatectomy via three different incision
MI (midline incision)
The living liver donors underwent hepatectomy using upper midline incision (10cm) without laparoscopic assistance
Procedure: hepatectomy midline incision
TI (transverse incision)
The living liver donors underwent hepatectomy using transverse incision with laparosocpic assistance
Procedure: hepatectomy transverse incision

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
donor recovery/quality of life (as measure bye the quality of recovery [OoR] score)
Time Frame: postoperative 7 day
QoR (quality of recovery) -15, has recently been developed, which can provide an extensive yet efficient evaluation of postoperative recovery from the patient's perspective [8]. The QoR-15 is an abbreviation of the longer and more comprehensive QoR-40 [15], and includes questions on pain, physical comfort, physical independence, psychological support and emotional state, and can be completed in approximately 2 minutes.
postoperative 7 day

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
consumption of analgesics on postoperative day
Time Frame: 1, 4, 8, 24, 48 and 72 h after surgery
1, 4, 8, 24, 48 and 72 h after surgery
discomfort related to the scar
Time Frame: postoperative 7 day
abdominal wall sensorineural deficits (numbness and differences in tactile and temperature sensations) and tightness around the scar
postoperative 7 day
discomfort related to the scar
Time Frame: postoperative 30 day
abdominal wall sensorineural deficits (numbness and differences in tactile and temperature sensations) and tightness around the scar
postoperative 30 day
side effects (nausea, vomiting, back pain, pruritus)
Time Frame: 1, 4, 8, 24, 48 and 72 h after surgery
nausea, vomiting, back pain, pruritus
1, 4, 8, 24, 48 and 72 h after surgery
donor recovery/quality of life (as measure bye the quality of recovery [OoR] score)
Time Frame: postoperative 30 day
QoR (quality of recovery) -15, has recently been developed, which can provide an extensive yet efficient evaluation of postoperative recovery from the patient's perspective [8]. The QoR-15 is an abbreviation of the longer and more comprehensive QoR-40 [15], and includes questions on pain, physical comfort, physical independence, psychological support and emotional state, and can be completed in approximately 2 minutes.
postoperative 30 day
assessment of subjective pain (as measured by numeric rating scale [NRS]) on postoperative day
Time Frame: 1, 4, 8, 24, 48 and 72 h after surgery
numeric rating scale (NRS) in which; 0 = no pain and 100 = worst pain
1, 4, 8, 24, 48 and 72 h after surgery

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.
Samsung Medical Center

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.
March 1, 2015

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 1, 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.
July 1, 2019

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).
April 2, 2015

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.
April 7, 2015

First Posted (Estimate)

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.
April 10, 2015

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.
July 25, 2019

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.
July 23, 2019

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.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 2015-01-016-002

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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