Ileus PostoperativeNCT07194525
Feasibility and Safety of an Ileus Management Protocol for Postoperative Ileus After Abdominal Surgery
A study testing 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 in people with Ileus Postoperative and Nasogastric Tube, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileus Postoperative, Nasogastric Tube
- What is being tested?
- 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 May 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age.
- Patients who undergo abdominal surgery and develop postoperative ileus (POI) within 30 days.
- Provided general consent for participation.
Who cannot join
- Preoperative bowel obstruction.
- Anastomotic leak.
- Prophylactic nasogastric tube (NGT) placement.
- Pregnancy.
- Lack of general consent.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, Canton of Vaud, 1005
About this study
Official title: Feasibility and Safety of an Ileus Management Protocol for Postoperative Ileus
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:
Read more
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
- Being tested
- 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
- Keywords
- ileus postoperative, treatment algorithm, hospital stay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 medicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From surgery until resolution of postoperative ileus (up to 30 days).
Secondary outcomes (5)
Nasogastric Tube (NGT) Reinsertion
Number and proportion of patients requiring reinsertion of the nasogastric tube after initial removal.
Measured: From surgery until resolution of postoperative ileus (up to 30 days).
Duration of Nasogastric Tube Placement
Total number of days the nasogastric tube remained in place for each patient.
Measured: 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.
Measured: 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
Measured: 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.
Measured: From initiation of conservative treatment until resolution of ileus, up to 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start31 May 2023
- Primary completion17 Jan 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileus PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Fuks, University of Lausanne Hospitals
- Investigators
- Fabian Grass, MD, Study director, University of Lausanne HospitalsDavid Fuks, MD, Study chair, University of Lausanne HospitalsTeresa Torres, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194525
- Sponsor's protocol ID
- 2023-00759
- Other IDs
- 2023
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of an Ileus Management Protocol for Postoperative Ileus
- ClinicalTrials.gov ID
- NCT07194525
- Acronym / sponsor ID
- 2023-00759
- Conditions
- Ileus Postoperative, Nasogastric Tube
- Keywords
- ileus postoperative, treatment algorithm, hospital stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ileus Management Protocol (I-MAP) | Other | 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 medicAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥18 years of age.
- Patients who undergo abdominal surgery and develop postoperative ileus (POI) within 30 days.
- Provided general consent for participation.
Key exclusion criteria (5 listed)
- Preoperative bowel obstruction.
- Anastomotic leak.
- Prophylactic nasogastric tube (NGT) placement.
- Pregnancy.
- Lack of general consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 medicThe 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. | Other | Ileus Management Protocol (I-MAP) |
Primary outcome
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.
5 secondary outcomes
Nasogastric Tube (NGT) Reinsertion
Time frame: From surgery until resolution of postoperative ileus (up to 30 days).
Duration of Nasogastric Tube Placement
Time frame: From initial placement until final removal, during index hospital stay, up to 30 days.
Hospital Length of Stay (LOS)
Time frame: From day of surgery until discharge, up to 30 days.
Conservative Treatment Failure
Time frame: From initiation of conservative treatment until resolution of ileus or re-intervention, up to 30 days after surgery.
Postoperative Ileus-Related Complications
Time frame: From initiation of conservative treatment until resolution of ileus, up to 30 days after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabian Grass, MD study director
University of Lausanne Hospitals
David Fuks, MD study chair
University of Lausanne Hospitals
Teresa Torres principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Ileus Postoperative and Nasogastric Tube, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the I-MAP Algorithm (time frame: From surgery until resolution of postoperative ileus (up to 30 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.