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临床试验/NCT04504487
NCT04504487已完成不适用

"Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy- a Randomized Controlled, Open Label, Pilot Study".

Institute of Liver and Biliary Sciences, India2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2021年1月28日最近更新:
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试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
2
主要终点
safety of drain removal using 3x3 rule - overall complications.

研究概览

简要总结

It's a randomized control trial to compare early drain removal versus standard drain removal after donor hepatectomy in terms of donor outcomes. We will analyse the data and elucidate the safety of early drain removal using 3x3 rule with routine drain removal.

详细描述

  • Prophylactic abdominal drainage after donor right hepatectomy for LDLT has been a common or even mandatory practice in most transplant centres.
  • This serves to monitor the occurrence of postoperative intraabdominal bleeding and is used for the detection and drainage of any bile leakage.
  • Below table mentions both advantages and disadvantages of prophylactic drain placement after hepatectomy.

Advantages

  1. Early detection of haemorrhage

  2. Early detection of bile leak

  3. Early reintervention Disadvantages

  4. Increased rates of intraabdominal and wound infection, 2. Increased abdominal pain, 3. Decreased pulmonary function, 4. Prolonged hospital stay, 5. Bowel injury.

  • Our study in ILBS for ALF donors, the overall complication rate was 20% as per Clavien-Dindo classification, of which a majority (15.9%) had grade 1 or 2 complications. Major complications (3b and above) were seen in 4 (1.0%) patients. Biliary complications were noted in 1.7% only.
  • In a study by Japanese group concluded that 3 × 3 rule is clinically feasible and allows for the early removal of the drain tube with minimum infection risk after liver resection. The ''3 x 3 rule'': the drain will be removed when the drain fluid bilirubin concentration is <3 mg/dl on day 3 after operation.
  • In our institute we remove drain routinely, when output is less than 100ml and serous. That is usually on postoperative day 5-7.
  • There is no randomized control trail done in donor hepatectomy comparing early versus standard drain removal.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • • Donors evaluated as per institutional protocol for donor hepatectomy and found fit
  • Those who consent

排除标准

  • Patients refusing to consent for inclusion in the study.
  • Left lateral hepatectomy.

结局指标

主要结局

safety of drain removal using 3x3 rule - overall complications.

时间窗: patient will be followed upto 3 months after surgery

Comprehensive complication index (CCI) - clavin dindo classification

次要结局

  • Length of hospital stay(patient will be followed upto 3 months after surgery)
  • Post operative pain relief(patient will be followed upto 3 months after surgery)
  • Surgical Site Infection (SSI)(patient will be followed upto 3 months after surgery)
  • Bile leak(patient will be followed upto 3 months after surgery)
  • reintervention rate(patient will be followed upto 3 months after surgery)
  • readmission rate(patient will be followed upto 3 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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