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

NCT ID: NCT07194525

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2024-04-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ileus Management Protocol (I-MAP)

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.

Group Type: 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

Intervention Type: 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.

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

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

David Fuks

Professor, Head of the Department of Visceral surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabian Grass, MD

Role: STUDY_DIRECTOR

University of Lausanne Hospitals

David Fuks, MD

Role: STUDY_CHAIR

University of Lausanne Hospitals

Teresa Torres

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Locations

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2023-00759

Identifier Type: -

Identifier Source: org_study_id