Study of Postoperative Ileus in Digestive Surgery

NCT06018961 | Recruiting

• 2 other identifiers: RC31/22/04912022-A02834-39
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Surgery

Keywords

Ileus; Colorectal surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Adult patients with digestive surgery

Patients who have planned abdominal surgery

Other: Post-operative ileus surgery

Interventions

Post-operative ileus surgery OTHER

Collection of ileus events, items of IFEED score and surgical complications

Adult patients with digestive surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population who have planned abdominal surgery

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

CHU de Toulouse

Toulouse, 31000, France

RECRUITING

INSERM

Toulouse, France

NOT YET RECRUITING

MeSH Terms

Conditions

Ileus

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Guillaume LE COSQUER, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume LE COSQUER, MD

CONTACT

5 61 32 27 61; lecosquer.g@chu-toulouse.fr

Etienne BUSCAIL, MD-PhD

CONTACT

5 61 32 23 73; buscail.e@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 31, 2023
• Study Start: April 24, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

FR (2)