IPCID: Study of Postoperative Ileus in Digestive Surgery

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06018961
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France (Other)
161
1
25
6.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
161 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Study of Postoperative Ileus in Digestive Surgery
Anticipated Study Start Date :
Nov 15, 2023
Anticipated Primary Completion Date :
Nov 15, 2025
Anticipated Study Completion Date :
Dec 15, 2025

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Complications of post-operative ileus surgery [1 month]

    Correlation between length of stay and Intake-Feeling nauseated-Emesis-physical Exam-Duration of symptoms (IFEED) score.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Guillaume LE COSQUER Toulouse France 31000

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Guillaume LE COSQUER, MD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT06018961
Other Study ID Numbers:
  • RC31/22/0491
  • 2022-A02834-39
First Posted:
Aug 31, 2023
Last Update Posted:
Aug 31, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 31, 2023