Drain vs No Drain After Live Donor Hepatectomy

Официальное название

Drain Versus No-Drain After Live Donor Hepatectomy- A Randomized Controlled, Pilot Study

Обзор

Prophylactic abdominal drain placement after donor hepatectomy has been a common or even mandatory practice in most transplant centers. This serves to monitor the occurrence of post-operative intra-abdominal bleeding and is used for the detection and drainage of any bile leakage. However prophylactic drain placement is not without complications, like; Increased rates of intraabdominal and wound infection, Increased abdominal pain, Decreased pulmonary function, Bowel injury and Prolonged hospital stay. Comprehensive Complication Index (CCI) is a valuable tool used to assess the overall morbidity of patients after surgical interventions . The CCI score ranges from 0 (no complication) to 100 (death), reflecting the gravity of the overall complication burden on the patient on a continuous scale and is a validated tool for living donor liver transplants. The investigators aim to compare the safety of no drain placement vs abdominal drain placement in LDLT(Live Donor Liver Transplant) by comparing the comprehensive complication index(CCI) between both arms at day of discharge after donor hepatectomy.

Подробное описание

* This study will be a randomised controlled, pilot study to compare the safety of no drain placement vs abdominal drain placement in LDLT by comparing the comprehensive complication index(CCI) between both arms at day of discharge after donor hepatectomy. * Patient admitted for donor hepatectomy will be recruited and further randomised into the Drain and No-Drain arms. Patients in the no drain arm will undergo routine steps in donor hepatectomy. After graft removal, hemostasis and biliostasis will be confirmed, following which abdomen will be closed in layers. For patients in the drain arm, same steps will be followed. At the end of the operation , additionally, 28 Fr abdominal drain will be inserted with tip near cut surface of remnant. Intraoperative and post-operative parameters will be compared between the groups. Comprehensive Complication index will be calculated on day of discharge using online universal CCI calculator application.

Вмешательства

• Другое No Drain i.e. Omission of abdominal drain placement
  Omission of abdominal drain placement in intervention arm. The No-drain arm will be compared to drain arm

Первичные конечные точки

• CCI index on post operative day 7 [Срок оценки: Admission one day prior to live donor hepatectomy till post operative day 7.]

Вторичные конечные точки (6)

• Infective complications [Срок оценки: Admission one day prior to live donor hepatectomy till post operative day 7]
• Duration of hospital stay [Срок оценки: Admission one day prior to live donor hepatectomy till post operative day 7]
• Paralytic ileus [Срок оценки: Admission one day prior to live donor hepatectomy till post operative day 7.]
• Bile leak [Срок оценки: Admission one day prior to live donor hepatectomy till post operative day 7]
• Hemorrhage [Срок оценки: Admission one day prior to live donor hepatectomy till post operative day 7]
• Post operative pain scores [Срок оценки: Admission one day prior to live donor hepatectomy till post operative day 7]

Критерии участия

Inclusion Criteria: Patients undergoing donor hepatectomy -

Критерии исключения

Any patient not consenting to the procedure. Intraoperative need for drain placement in no drain arm due to surgical factors.

Inverted L/ J shaped incision. Laparoscopic donor hepatectomy Robotic donor hepatectomy.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Индия · 1 центр

• Marengo Asia Hospitals — Faridabad

Идентификаторы

NCT: NCT06769776 · MAHF/AP/LTP-1/EC/2024/04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗