Clinical trial NCT02413983: Comparison of Postoperative Outcome of Hepatectomy for Living Donors According to Three Different Incision
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Donors for Liver Transplantation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: donor recovery/quality of life (as measure bye the quality of recovery [OoR] score)
timeFrame: postoperative 7 day
Secondary outcomes:
measure: consumption of analgesics on postoperative day
timeFrame: 1, 4, 8, 24, 48 and 72 h after surgery
measure: discomfort related to the scar
timeFrame: postoperative 7 day
measure: discomfort related to the scar
timeFrame: postoperative 30 day
measure: side effects (nausea, vomiting, back pain, pruritus)
timeFrame: 1, 4, 8, 24, 48 and 72 h after surgery
measure: donor recovery/quality of life (as measure bye the quality of recovery [OoR] score)
timeFrame: postoperative 30 day
measure: assessment of subjective pain (as measured by numeric rating scale [NRS]) on postoperative day
timeFrame: 1, 4, 8, 24, 48 and 72 h after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: