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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Donors for Liver Transplantation

Intervention / Treatment
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* Procedure: hepatectomy conventional incision
* Procedure: hepatectomy midline incision
* Procedure: hepatectomy transverse incision


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CI (conventional incision)<br>The living liver donors underwent hepatectomy using right subcostal incision with a midline extension (conventional incision) | Procedure: hepatectomy conventional incision<br>* 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<br>|
| MI (midline incision)<br>The living liver donors underwent hepatectomy using upper midline incision (10cm) without laparoscopic assistance | Procedure: hepatectomy midline incision<br> <br> |
| TI (transverse incision)<br>The living liver donors underwent hepatectomy using transverse incision with laparosocpic assistance | Procedure: hepatectomy transverse incision<br> <br> |

What is the study measuring?
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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 |