ClinicalTrials.gg
RecruitingNCT06018961IPCIDUpdated Dec 31, 2025

Study of Postoperative Ileus in Digestive Surgery

An observational study in Colorectal Surgery, sponsored by University Hospital, Toulouse. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-31.

Sponsored by University Hospital, Toulouse · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
161
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal Surgery

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Keywords

  • Ileus
  • Colorectal surgery
03

In context

Ileus

167 studies on the registry are indexed under Ileus; 23 are open to participants now.

This study's planned enrollment of 161 is close to the median of 159 across 26 observational studies indexed under Ileus.

Browse Ileus studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Population who have planned abdominal surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 site
  • Multiple digestive resection
  • Colorectal anastomosis less than 7 cm from the anal margin (below the Pouch of Douglas)
  • Patient with physical status (ASA) score > 2
  • Patient with an (ECOG) Performance Status Scale >2
  • Pregnant or breastfeeding women
  • Patient under a protection regime for adults (guardianship, curators, safeguard of justice)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
161 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adult patients with digestive surgery

    Patients who have planned abdominal surgery

    Other: Post-operative ileus surgery

Interventions

  • OtherPost-operative ileus surgery

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

06

What researchers measure

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.

    Time frame: 1 month

07

Study locations

1 of 2 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06018961
Responsible party
Sponsor
First posted
Aug 31, 2023
Start date
Apr 24, 2024
Primary completion
Jun 15, 2026 (estimated)
Completion
Jun 15, 2026 (estimated)
Last update
Dec 31, 2025

Study contacts

Guillaume LE COSQUER, MD
Contact
lecosquer.g@chu-toulouse.fr
5 61 32 27 61 ext. +33
Etienne BUSCAIL, MD-PhD
Contact
buscail.e@chu-toulouse.fr
5 61 32 23 73 ext. +33
Guillaume LE COSQUER, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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