Postoperative IleusMICRO-IPONCT05512741
Intestinal Microbiota and Postoperative Ileus After Colorectal Surgery
An observational study of Postoperative Ileus and Surgery-Complications, run by University Hospital, Angers at 1 site in France.
Trial summary
Postoperative ileus (POI) after colorectal surgery is frequent and is a burden for national health authority because it increases the morbidity and the length of hospital stay. Some of the stage of the mechanism of POI are known and are now targeted to reduce its occurence but despite these measures, POI still happens… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus, Surgery-Complications
- What is being tested?
- Feces collection
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2022to 26 May 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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
Study population: 10 patients with POI and 10 patients without POI selected in the consecutive patients undergoing colorectal surgery during the period of inclusion.
Who may be able to join
- laparoscopic colorectal resection with anastomosis and without diverting stoma
Who cannot join
- risk of modification of the microbiota (terminal enterostomy, chronic inflammatory bowel disease, oesophageal or gastric surgery, vagal nerves lesion, beta lactamin allergy, bowel cleansing)
- postoperative complication
Trial locations and contacts
1 site in 1 country.
France1 site
Angers University Hospital, visceral and endocrine surgery department
Angers, 49000
About this study
Official title: Evaluation of the Role of the Intestinal Microbiota in the Mechanism of Postoperative Ileum After Colorectal Surgery : a Preliminary Study
Postoperative ileus (POI) after colorectal surgery is frequent and is a burden for national health authority because it increases the morbidity and the length of hospital stay.
Some of the stage of the mechanism of POI are known and are now targeted to reduce its occurence but despite these measures, POI still happens in 10-30% of surgeries.
The role of the intestinal microbiota in POI is unknown while it could be a new target to reduce its duration or its occurence.
- Conditions
- Postoperative Ileus, Surgery-Complications
- Being tested
- Feces collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feces collectionOther
Feces will be collected, at home, by the patient., by using a collection kit. The stools are collected in the 2 last days before surgery.
After surgery, the first stool is collected, during the hospitalization, by using the same kit. Stools are conserved in the same condition, before being frozen in our local biologic ressources center.
| Study group | Role | What they receive |
|---|---|---|
| Group Ileus | Patients that experience POI after colorectal surgery. POI is defined by the presence of 2 of the 5 criteria of Vather from the first postoperative day.
The first 10 consecutive patients experiencing POI will be included in the study. Receives: Other: Feces collection | |
| No POI group | Patients that do not experience POI. The 10 patients having the fastest recovery of gastro-intestinal functions after surgery during the period of inclusion will be included in the study Receives: Other: Feces collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of the feces microbiota before surgery
The composition of the microbiota will be assessed by the analysis of the region V3 V4 of the 16S rRNA, amplificateur by high flow sequencing
Measured: within the 2 last days before surgery
Composition of the feces microbiota after surgery
The composition of the microbiota will be assessed by the analysis of the region
Measured: up to the first postoperative stools, an average of 3 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start21 Oct 2022
- Primary completion26 May 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512741
- Sponsor's protocol ID
- MicroIPO2022
- Acronym
- MICRO-IPO
- Status last verified
- Jun 2025
- First submitted
- 10 Aug 2022
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of the Intestinal Microbiota in the Mechanism of Postoperative Ileum After Colorectal Surgery : a Preliminary Study
- ClinicalTrials.gov ID
- NCT05512741
- Acronym / sponsor ID
- MICRO-IPO / MicroIPO2022
- Conditions
- Postoperative Ileus, Surgery-Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 23 Aug 2022 (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.
Postoperative ileus (POI) after colorectal surgery is frequent and is a burden for national health authority because it increases the morbidity and the length of hospital stay.
Some of the stage of the mechanism of POI are known and are now targeted to reduce its occurence but despite these measures, POI still happens in 10-30% of surgeries.
The role of the intestinal microbiota in POI is unknown while it could be a new target to reduce its duration or its occurence.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Ileus | – | Other: Feces collectionPatients that experience POI after colorectal surgery. POI is defined by the presence of 2 of the 5 criteria of Vather from the first postoperative day. The first 10 consecutive patients experiencing POI will be included in the study. |
| No POI group | – | Other: Feces collectionPatients that do not experience POI. The 10 patients having the fastest recovery of gastro-intestinal functions after surgery during the period of inclusion will be included in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 10 patients with POI and 10 patients without POI selected in the consecutive patients undergoing colorectal surgery during the period of inclusion.
Key inclusion criteria (1 listed)
- laparoscopic colorectal resection with anastomosis and without diverting stoma
Key exclusion criteria (2 listed)
- risk of modification of the microbiota (terminal enterostomy, chronic inflammatory bowel disease, oesophageal or gastric surgery, vagal nerves lesion, beta lactamin allergy, bowel cleansing)
- postoperative complication
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 |
|---|---|---|
| Feces collectionFeces will be collected, at home, by the patient., by using a collection kit. The stools are collected in the 2 last days before surgery. After surgery, the first stool is collected, during the hospitalization, by using the same kit. Stools are conserved in the same condition, before being frozen in our local biologic ressources center. | Other | Group Ileus, No POI group |
Primary outcome
Composition of the feces microbiota before surgery
Time frame: within the 2 last days before surgery
The composition of the microbiota will be assessed by the analysis of the region V3 V4 of the 16S rRNA, amplificateur by high flow sequencing
Composition of the feces microbiota after surgery
Time frame: up to the first postoperative stools, an average of 3 postoperative days
The composition of the microbiota will be assessed by the analysis of the region
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 15 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Ileus and Surgery-Complications, run by University Hospital, Angers at 1 site in France.
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 1 inclusion and 2 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 15 Jun 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 France. 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?
Composition of the feces microbiota before surgery (time frame: within the 2 last days before surgery). The study lists 2 primary outcomes in all. 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 15 Jun 2025.