Intestinal Microbiota and Postoperative Ileus After Colorectal Surgery

NCT ID: NCT05512741

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-21
• Study Completion Date: 2025-05-26

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Feces collection

Intervention Type: 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.

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

Feces collection

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Angers University Hospital, visceral and endocrine surgery department

Angers, , France

Countries

France

Other Identifiers

MicroIPO2022

Identifier Type: -

Identifier Source: org_study_id