Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-01-06 @ 6:49 AM
Study NCT ID:
NCT06018961
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2023-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Postoperative Ileus in Digestive Surgery
Sponsor:
University Hospital, Toulouse
Organization:
Study Overview
Official Title:
Study of Postoperative Ileus in Digestive Surgery
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPCID
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-A02834-39 | OTHER | ID-RCB | View |