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CompletedNCT05512741MICRO-IPOUpdated Jun 15, 2025

Intestinal Microbiota and Postoperative Ileus After Colorectal Surgery

An observational study in Postoperative Ileus and Surgery-Complications, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-15.

Sponsored by University Hospital, Angers · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
64
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Postoperative Ileus
  • Surgery-Complications

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In context

Ileus

167 studies on the registry are indexed under Ileus; 23 are open to participants now.

This study's enrollment of 64 is below the median of 159 across 26 observational studies indexed under Ileus.

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Lead sponsor

University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

10 patients with POI and 10 patients without POI selected in the consecutive patients undergoing colorectal surgery during the period of inclusion.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • laparoscopic colorectal resection with anastomosis and without diverting stoma

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
64 participants (actual)
Target follow-up
30 Days
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

    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

    Other: Feces collection

Interventions

  • OtherFeces collection

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: within the 2 last days before surgery

  2. Composition of the feces microbiota after surgery

    The composition of the microbiota will be assessed by the analysis of the region

    Time frame: up to the first postoperative stools, an average of 3 postoperative days

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Study locations

1 site
  • Angers University Hospital, visceral and endocrine surgery department
    Angers, 49000, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05512741
Responsible party
Sponsor
First posted
Aug 23, 2022
Start date
Oct 21, 2022
Primary completion
May 26, 2025
Completion
May 26, 2025
Last update
Jun 15, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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