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

Lausanne University Hospital (CHUV)

Status: Completed

Conditions: Ileus Postoperative; Nasogastric Tube

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT07194525

2023-00759

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Ileus Management Protocol (I-MAP)

Other group

Description:

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.

Treatment:

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