Intestinal Microbiota and Postoperative Ileus After Colorectal Surgery

NCT05512741 | Completed DMC

• 1 other identifier: MicroIPO2022
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Ileus; Surgery-Complications

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Feces collection OTHER

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.

Group Ileus; No POI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• laparoscopic colorectal resection with anastomosis and without diverting stoma

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Angers University Hospital, visceral and endocrine surgery department

Angers, 49000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

collection of feces before and after surgery

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 23, 2022
• Study Start: October 21, 2022
• Primary Completion: May 26, 2025
• Study Completion: May 26, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

FR (1)