Study of Postoperative Ileus in Digestive Surgery (IPCID)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Surgery
• Intervention / Treatment: Other: Post-operative ileus surgery

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 Type: Observational
• Enrollment (Estimated): 161

Contacts and Locations

• Study Contact: Name: Guillaume LE COSQUER, MD; Phone Number: +33 5 61 32 27 61; Email: lecosquer.g@chu-toulouse.fr
• Study Contact Backup: Name: Etienne BUSCAIL, MD-PhD; Phone Number: +33 5 61 32 23 73; Email: buscail.e@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31000
    • CHU de Toulouse
    • Contact: Guillaume LE COSQUER, MD; Phone Number: +33 561322761; Email: lecosquer.g@chu-toulouse.fr
    • Principal Investigator: Guillaume LE COSQUER, MD
    • Sub-Investigator: Etienne BUSCAIL, MD-PhD
  • Toulouse, France
    • Inserm
    • Contact: Etienne BUSCAIL, MD-PhD; Phone Number: +33 05 61 32 23 73; Email: buscail.e@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Population who have planned abdominal surgery

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult patients with digestive surgery; Patients who have planned abdominal surgery	Other: Post-operative ileus surgery; Collection of ileus events, items of IFEED score and surgical complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications of post-operative ileus surgery	Correlation between length of stay and Intake-Feeling nauseated-Emesis-physical Exam-Duration of symptoms (IFEED) score.	1 month

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Guillaume LE COSQUER, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2023
• Primary Completion (Estimated): November 15, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Colorectal surgery; Ileus
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus
• Other Study ID Numbers: RC31/22/0491; 2022-A02834-39 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No