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

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: Completed
• Conditions: Healthy Donors for Liver Transplantation
• Intervention / Treatment: Procedure: hepatectomy conventional incision; Procedure: hepatectomy midline incision; Procedure: hepatectomy transverse incision

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
donor recovery/quality of life (as measure bye the quality of recovery [OoR] score)	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

Outcome Measure	Measure Description	Time Frame
consumption of analgesics on postoperative day		1, 4, 8, 24, 48 and 72 h after surgery
discomfort related to the scar	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	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)	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)	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	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

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: April 2, 2015
• First Submitted That Met QC Criteria: April 7, 2015
• First Posted (Estimate): April 10, 2015

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 2015-01-016-002