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临床试验/CTRI/2026/02/104800
CTRI/2026/02/104800尚未招募3 期

Effect of Extended Peritoneal Lavage on Post operative Outcome in Open Abdominal Surgeries for Gastrointestinal, Hepatopancreatobiliary and Gynecological Malignancies: An Open label Randomized Controlled Trial

AIIMS Bhubaneswar1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2026年3月9日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
126
试验地点
1

研究概览

简要总结

Peritoneal lavage following resection has been widely used following surgeries prior to closure of abdomen,  for ensuring hemostasis and removing debris. It has been in practice following hollow viscus perforation but standard volume of lavage has not yet been defined. Though results have been promising in terms of reduction of surgical site infection, there is heterogeneity in terms of volume of lavage, nature of fluid used (normal saline vs antiseptic vs cytotoxic agents), temperature of fluid (warm vs room-temperature) which contribute to differences in outcomes. Most high-quality RCTs focus on gastric cancer. There are limited number of RCTs on impact of routine extended intraoperative lavage (EIPL) in hepatocellular cancer, colorectal, gynecologic and hepatobiliary malignancies. Lastly, most of the previous studies on EIPL in abdominal surgeries for malignancies have focussed on recurrence free survival and disease free survival. The impact on short term outcomes has been less frequently studied. This study aims to assess the impact of extended intraperitoneal lavage on postoperative outcome in surgeries for abdominal malignancies.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Open abdominal oncologic surgery with planned resection (e.g., gastric, colorectal, hepatic resections) under curative intent Complete hemostasis during surgery ASA I, II Willing to provide informed consent.

排除标准

  • Pre-existing peritonitis Bowel Perforation Gross Intraoperative Spillage Bowel Obstruction Uncontolled Diabetes Renal, Liver, Heart failure Pregnancy.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dripta Ramya Sahoo

AIIMS Bhubaneswar

研究点 (1)

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