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临床试验/NCT06018961
NCT06018961招募中不适用

Study of Postoperative Ileus in Digestive Surgery

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2024年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
161
试验地点
2
主要终点
Complications of post-operative ileus surgery

研究概览

简要总结

Post-operative ileus is a temporary stoppage of bowel function following surgery. Indeed it can occur in 20% of cases during post-operative follow-up of bowel surgery. The absence of resumption of transit can lead to the implementation of specific treatments such as the placement of a nasogastric tube and drug treatments. To date, the definition of this event is not accepted by everyone and is not based on reproducible evaluation criteria. The main objective of this study is to evaluate a score used to date to define postoperative ileus, the IFEED score, and to compare it to the length of postoperative stay.

详细描述

Postoperative ileus (also known as paralytic ileus) is defined as a temporary cessation of gastrointestinal peristalsis. This complication occurs mainly following gastrointestinal surgery. It can be noted that postoperative ileus also occurs postoperatively after pelvic and extra-abdominal surgery with a lower incidence. The incidence of ileus varies depending on the cohorts, however the rate of occurrence can be up to 20% post-operative colorectal surgery.The main principles of treatment are the fasting of the patient and the introduction of a nasogastric tube to ensure gastric emptying in order to prevent complications of vomiting such as bronchial aspiration. This pathological phenomenon is frequent and significantly lengthens the duration of hospitalization and postoperative morbidity and mortality. The duration of hospitalization is the only objective and reproducible criterion in the evaluation of ileus. One of the problems of postoperative ileus is first of all its evaluation and the implementation of a reproducible definition. A recent consensus conference of the American Society for Engaged Recovery and Perioperative Quality Initiative proposed a return definition of transit based on an IFEED (Intake-Feeling Nauseated-Emesis-Physical Exam-Duration of Symptoms) clinical score. However, this score has never been evaluated prospectively in a cohort of patients operated on for pathologies of the digestive tract. This is a descriptive, diagnostic, prospective, monocentric study. We will include patients entering our care sector for a gastrointestinal surgery. We will follow patient from the surgery to the end of their hospital stay.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Patient entering our care sector for surgical management of a pathology affecting the digestive tract:
  • Colorectal cancer
  • Chronic inflammatory bowel disease
  • Colonic diverticulosis.

排除标准

  • Patient treated for digestive resection with associated resection procedure or to be treated with intraperitoneal chemotherapy.
  • Patient presenting during hospitalization with an ileus secondary to another intra-abdominal complication.
  • Patient cared for in an emergency
  • Hepatic resection or other associated metastatic site
  • Multiple digestive resection
  • Colorectal anastomosis less than 7 cm from the anal margin (below the Pouch of Douglas)
  • Patient with American Society of Anesthesiologists physical status (ASA) score > 2
  • Patient with an Eastern Cooperative Oncology Group (ECOG) Performance Status Scale >2
  • Pregnant or breastfeeding women
  • Patient under a protection regime for adults (guardianship, curators, safeguard of justice)

结局指标

主要结局

Complications of post-operative ileus surgery

时间窗: 1 month

Correlation between length of stay and Intake-Feeling nauseated-Emesis-physical Exam-Duration of symptoms (IFEED) score.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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