Intestinal Microbiota and Postoperative Ileus After Colorectal Surgery (MICRO-IPO)

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Ileus; Surgery-Complications
• Intervention / Treatment: Other: Feces collection

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

Inclusion Criteria:

• laparoscopic colorectal resection with anastomosis and without diverting stoma

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	up to the first postoperative stools, an average of 3 postoperative days

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Actual): May 26, 2025
• Study Completion (Actual): May 26, 2025

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 20, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Obstruction; Ileus
• Other Study ID Numbers: MicroIPO2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No