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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ileus Management Protocol (I-MAP) | Other | All enrolled patients who develop postoperative ileus after abdominal surgery are managed according to the standardized Ileus Management Protocol (I-MAP). The algorithm is based on nasogastric tube (NGT) output and includes stepwise interventions: Administration of water-soluble contrast (Telebrix® gastro, ioxitalamic acid 300 mg/mL) 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 in 500 mL NaCl 0.9% over 5 hours) as a prokinetic, only after small bowel obstruction is excluded. The protocol is applied until resolution of postoperative ileus or requirement for further intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the I-MAP Algorithm | Proportion of eligible patients with postoperative ileus who are managed according to the standardized Ileus Management Protocol (I-MAP). A protocol adherence rate of ≥85% is considered indicative of feasibility. | From surgery until resolution of postoperative ileus (up to 30 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Nasogastric Tube (NGT) Reinsertion | Number and proportion of patients requiring reinsertion of the nasogastric tube after initial removal. | From surgery until resolution of postoperative ileus (up to 30 days). |
| Duration of Nasogastric Tube Placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabian Grass, MD | University of Lausanne Hospitals | Study Director |
| David Fuks, MD | University of Lausanne Hospitals | Study Chair |
| Teresa Torres | University of Lausanne Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier universitaire vaudois (CHUV) | Lausanne | Canton of Vaud | 1005 | Switzerland |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 15, 2025 | Sep 18, 2025 |
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|
Total number of days the nasogastric tube remained in place for each patient.
| From initial placement until final removal, during index hospital stay, up to 30 days. |
| Hospital Length of Stay (LOS) | Total number of days spent in hospital after surgery, including any delays related to postoperative ileus management. | From day of surgery until discharge, up to 30 days. |
| Conservative Treatment Failure | Proportion of patients in whom conservative management per I-MAP failed, requiring additional interventions | From initiation of conservative treatment until resolution of ileus or re-intervention, up to 30 days after surgery. |
| Postoperative Ileus-Related Complications | Incidence of complications potentially related to postoperative ileus, including pneumonia, bronchoaspiration, and other adverse events associated with POI management. | From initiation of conservative treatment until resolution of ileus, up to 30 days after surgery. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
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