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

NCT07194525 | Completed

• 1 other identifier: 2023-00759
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ileus postoperative; treatment algorithm; hospital stay

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (5)

• Nasogastric Tube (NGT) Reinsertion

  From surgery until resolution of postoperative ileus (up to 30 days).

• Duration of Nasogastric Tube Placement

  From initial placement until final removal, during index hospital stay, up to 30 days.

• Hospital Length of Stay (LOS)

  From day of surgery until discharge, up to 30 days.

• Conservative Treatment Failure

  From initiation of conservative treatment until resolution of ileus or re-intervention, up to 30 days after surgery.

• Postoperative Ileus-Related Complications

  From initiation of conservative treatment until resolution of ileus, up to 30 days after surgery.

Study Arms (1)

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.

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

Interventions

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.

Ileus Management Protocol (I-MAP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years of age.
• Patients who undergo abdominal surgery and develop postoperative ileus (POI) within 30 days.
• Provided general consent for participation.

You may not qualify if:

• Preoperative bowel obstruction.
• Anastomotic leak.
• Prophylactic nasogastric tube (NGT) placement.
• Pregnancy.
• Lack of general consent.

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Canton of Vaud, 1005, Switzerland

Location

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of the Department of Visceral surgery

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 26, 2025
• Study Start: May 31, 2023
• Primary Completion: January 17, 2024
• Study Completion: April 1, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)