Intestinal Microbiota and Postoperative Ileus After Colorectal Surgery

Postoperative Ileus Clinical Trial

— MICRO-IPO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05512741
• Other study ID #: MicroIPO2022
• Status: Recruiting
• Start date: October 21, 2022
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Angers
• Contact: Aurélien Venara, MD, PhD
• Phone: 0033241353618
• Email: auvenara[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

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.

Locations

Country	Name	City	State
France	Angers University Hospital, visceral and endocrine surgery department	Angers

Sponsors (2)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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