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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
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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