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Feasibility and Safety of an Ileus Management Protocol for Postoperative Ileus After Abdominal Surgery

NCT07194525 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-26

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether a standardized treatment algorithm, the Ileus Management Protocol (I-MAP), is feasible and safe for the management of patients who develop postoperative ileus (POI) within 30 days after abdominal surgery.

The main questions it aims to answer are:

Can I-MAP be applied consistently, with ≥85% adherence, in eligible patients with POI?

Is the use of I-MAP associated with acceptable safety outcomes, including low rates of complications such as pneumonia, aspiration, and adverse events?

This study does not include a comparison group. All participants are assigned to the I-MAP protocol, and outcomes are evaluated prospectively.

Participants will:

Be monitored for POI symptoms (nausea, vomiting, bloating, absence of gas/stool).

Receive standardized management according to I-MAP, which includes:

Daily assessment of nasogastric tube (NGT) output.

Water-soluble contrast administration via NGT when indicated.

Imaging (CT scan or X-ray) if obstruction is suspected.

Neostigmine administration if small bowel obstruction is excluded.

The primary endpoint is the feasibility of I-MAP, defined as the proportion of POI patients treated according to the algorithm. Secondary outcomes include NGT reinsertion, duration of NGT placement, hospital length of stay, conservative treatment failure, and complications related to POI.

Conditions

  • Ileus Postoperative
  • Nasogastric Tube

Interventions

OTHER

A standardized treatment algorithm for postoperative ileus after abdominal surgery, based on nasogastric tube output and including stepwise use of water-soluble contrast, imaging, and prokinetic medic

The Ileus Management Protocol (I-MAP) is a standardized algorithm for the treatment of postoperative ileus (POI) after abdominal surgery. Management decisions are based on nasogastric tube (NGT) output measured every 12 hours. Depending on output and tolerance, patients may receive: Water-soluble contrast (Telebrix® gastro, ioxitalamic acid 300 mg/mL) administered via NGT, followed by a clamp test at 4 hours. Diagnostic imaging (CT-scan or X-ray) if ileus persists or small bowel obstruction is suspected. Intravenous Neostigmine® (2.5 mg diluted in 500 mL NaCl 0.9%, infused over 5 hours) as a prokinetic, only after small bowel obstruction is excluded. The protocol is applied until resolution of POI or requirement of further intervention.

Sponsors & Collaborators

  • University of Lausanne Hospitals

    lead OTHER

Principal Investigators

  • Fabian Grass, MD · University of Lausanne Hospitals

  • David Fuks, MD · University of Lausanne Hospitals

  • Teresa Torres · University of Lausanne Hospitals

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2024-01-17
Completion
2024-04-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07194525 on ClinicalTrials.gov