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Clinical Trials/NCT02413983
NCT02413983CompletedNot Applicable

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

Samsung Medical Center1 site in 1 country60 target enrollmentStarted: March 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
donor recovery/quality of life (as measure bye the quality of recovery [OoR] score)

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • donor recovery/quality of life (as measure bye the quality of recovery [OoR] score)(postoperative 30 day)
  • assessment of subjective pain (as measured by numeric rating scale [NRS]) on postoperative day(1, 4, 8, 24, 48 and 72 h after surgery)
  • consumption of analgesics on postoperative day(1, 4, 8, 24, 48 and 72 h after surgery)
  • side effects (nausea, vomiting, back pain, pruritus)(1, 4, 8, 24, 48 and 72 h after surgery)
  • discomfort related to the scar(postoperative 30 day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gaab Soo Kim

Samsung Medical Center

Samsung Medical Center

Study Sites (1)

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