跳至主要内容
临床试验/NCT02413983
NCT02413983已完成不适用

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 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
donor recovery/quality of life (as measure bye the quality of recovery [OoR] score)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA (American Society of Anesthesiologists) physical status I-II,
  • adult undergoing hepatectomy for living donors

排除标准

  • 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

结局指标

主要结局

donor recovery/quality of life (as measure bye the quality of recovery [OoR] score)

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gaab Soo Kim

Samsung Medical Center

Samsung Medical Center

研究点 (1)

Loading locations...

相似试验

Comparison of Postoperative Outcome of Hepatectomy... | 临床试验