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Completed

NCT Number: NCT07194525

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

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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Key information

Conditions

Ileus Postoperative Nasogastric Tube

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Canton of Vaud, 1005, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of the I-MAP Algorithm

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

    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.

Secondary outcomes

  1. Nasogastric Tube (NGT) Reinsertion

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

    Number and proportion of patients requiring reinsertion of the nasogastric tube after initial removal.

  2. Duration of Nasogastric Tube Placement

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

    Total number of days the nasogastric tube remained in place for each patient.

  3. Hospital Length of Stay (LOS)

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

    Total number of days spent in hospital after surgery, including any delays related to postoperative ileus management.

  4. Conservative Treatment Failure

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

    Proportion of patients in whom conservative management per I-MAP failed, requiring additional interventions

  5. Postoperative Ileus-Related Complications

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

    Incidence of complications potentially related to postoperative ileus, including pneumonia, bronchoaspiration, and other adverse events associated with POI management.

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study title

Feasibility and Safety of an Ileus Management Protocol for Postoperative Ileus

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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