Study of Postoperative Ileus in Digestive Surgery

Colorectal Surgery Clinical Trial

— IPCID  

Official title:

Study of Postoperative Ileus in Digestive Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06018961
• Other study ID #: RC31/22/0491
• Secondary ID: 2022-A02834-39
• Status: Not yet recruiting
• Start date: November 15, 2023
• Est. completion date: December 15, 2025

Study information

• Verified date: September 2023
• Source: University Hospital, Toulouse
• Contact: Guillaume LE COSQUER, MD
• Phone: 5 61 32 27 61
• Email: lecosquer.g[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 161
• Est. completion date: December 15, 2025
• Est. primary completion date: November 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Surgery
• Ileus

Intervention

Other:
• Post-operative ileus surgery
Collection of ileus events, items of IFEED score and surgical complications

Locations

Country	Name	City	State
France	CHU de Toulouse	Toulouse
France	INSERM	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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