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

Healthy Donors for Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413983
• Other study ID #: 2015-01-016-002
• Status: Completed
• Start date: March 2015
• Est. completion date: July 2019

Study information

• Verified date: July 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2019
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Donors for Liver Transplantation

Intervention

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
• hepatectomy midline incision

• hepatectomy transverse incision

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	consumption of analgesics on postoperative day		1, 4, 8, 24, 48 and 72 h after surgery
Secondary	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
Secondary	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
Secondary	side effects (nausea, vomiting, back pain, pruritus)	nausea, vomiting, back pain, pruritus	1, 4, 8, 24, 48 and 72 h after surgery
Secondary	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
Secondary	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