MICRO-IPO: Intestinal Microbiota and Postoperative Ileus After Colorectal Surgery

Sponsor

University Hospital, Angers (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05512741

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Ileus Surgery-Complications	Other: Feces collection

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Evaluation of the Role of the Intestinal Microbiota in the Mechanism of Postoperative Ileum After Colorectal Surgery : a Preliminary Study

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

Composition of the feces microbiota before surgery [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Angers
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT05512741

Other Study ID Numbers:

MicroIPO2022

First Posted:

Aug 23, 2022

Last Update Posted:

Aug 23, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ileus

Study Results

No Results Posted as of Aug 23, 2022