Microbiota Implementation to Reduce Anastomotic Colorectal Leaks (MIRACLe)

NCT05164887 | Completed

• 1 other identifier: 1.0
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this study is to implement the intestinal microbiota by perioperative administration of probiotics, oral antibiotics and low volume mechanical preparation in order to reduce the incidence of colorectal anastomotic leaks and dehiscences.

Conditions

Colorectal Cancer; Surgery; LAP; Anastomotic Leak; Microbial Substitution

Outcome Measures

Primary Outcomes (1)

• Incidence of Fistulas and Anastomotic Leaks

  Evaluation of incidence of AL compared to a group of 500 colorectal resection in patient prepared with ev antibiotics, no MBP and without probiotics administration

  4 weeks

Secondary Outcomes (1)

• Incidence of SSI

  4 weeks

Study Arms (1)

MIRACLe patients

Patient affected by colorectal cancer submitted to laparoscopic resection with MBP + OA + perioperative Probiotics administration. MBP = oral polyphosphate 500ml preoperative OA = Amoxicillin/Clavulanic acid 1g x 2 + metronidazole 250mg x 3 Probiotics = Streptococcus thermophilus; Bifidobacterium breve; Bifidobacterium longum; Bifidobacterium infantis; Lactobacillus acidophilus; Lactobacillus plantarum; Lactobacillus paracasei; Lactobacillus delbrueckii subsp. Bulgaricus 4,4g x 2

Procedure: Laparoscopic colorectal resection

Interventions

Laparoscopic colorectal resection PROCEDURE

the patients candidate to laparoscopic colorectal resection for cancer are perioperatively treated with mechanical bowel preparation, oral antibiotics and administration of probiotics

Also known as: Perioperative bowel preparation

MIRACLe patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients affected by colorectal cancer submitted to laparoscopic resections with ileo- colo- rectal anastomoses

You may qualify if:

• Age \> 18 years
• ASA I - II - III
• Colorectal cancer
• Elective surgery
• Laparoscopic resections

You may not qualify if:

• Age \< 18 years
• ASA IV
• Emergency surgery
• Laparotomic resections
• Diverticular disease or IBD
• Hartmann or Miles procedures
• Stomies
• Major intraoperative complications

Sponsors & Collaborators

• S.Eugenio Hospital: lead
• Domenico Spoletini, M.D. PhD: collaborator
• Michele Grieco, M.D.: collaborator
• Rosa Marcellinaro, M.D PhD: collaborator
• Andrea Mingoli, M.D. PhD: collaborator
• Rosa Menditto, M.D.: collaborator
• Vincenzo Napoleone, PhD: collaborator
• Gioia Brachini, M.D. PhD: collaborator

Study Sites (1)

S Eugenio Hospital

Roma, 00144, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Surgery - Head of General Surgery Unit

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 21, 2021
• Study Start: December 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)