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Analysis of the Composition of the Intestinal Microbiota in Patients Post-intestinal Anastomosis

Analysis of the Composition of the Intestinal Microbiota and Its Evolution in Patients Post-intestinal Anastomosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07416760
Acronym
MIDESIN
Enrollment
30
Registered
2026-02-18
Start date
2026-02-14
Completion date
2026-12-14
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Surgery

Keywords

Microbiome, intestinal anastomosis, dehiscence

Brief summary

Recent research suggests a significant link between gut microbiota and anastomotic leakage (AL) in colorectal surgery. Patients who develop AL have a higher abundance of bacteria from the Lachnospiraceae family and lower microbial diversity. Considering the bibliographic data, our main interest is to analyze the microbial population of patients in our social environment and then look for differences in the microbiome between those who have suffered an anastomotic dehiscence (around 8-9% according to the results of our hospital's Surgery Department) and those who have not.

Detailed description

The study is designed as a prospective, descriptive, non-interventional research project in which some variables will be analyzed transversally. Patients will be selected by the clinical members of the research team from within the population in our setting who will undergo abdominal surgery involving colorectal intestinal anastomosis. Once accepted, stool samples will be requested prior to surgical preparation, during surgery, and afterwards to determine their microbiome; in this way, we will attempt to correlate the evolution of their anastomosis with their intestinal bacterial population.

Interventions

OTHERNot applicable- observational study

Fecal sample collection

Sponsors

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients who have undergone colorectal intestinal anastomosis. * Signing of the informed consent form. * Age ≥18 years with good functional status. * Availability for postoperative follow-up.

Exclusion criteria

* Emergency surgery. * Intra-abdominal sepsis or previous dehiscence. * Severe immunosuppression. * Use of antibiotics in the 3 months prior to preoperative preparation. * Pregnancy or breastfeeding.

Design outcomes

Primary

MeasureTime frameDescription
Understand the patient's microbiomeFrom enrollment to a month post surgeryTo understand the microbiome of patients undergoing colorectal surgery and the effect of current surgical preparation on the microbiota in our local population.

Secondary

MeasureTime frameDescription
Predictive indicators of colorectal anastomosis postsurgeryFrom surgery to a monthPredictive indicators of postoperative outcomes in patients undergoing colorectal anastomosis surgery through metagenomic characterization of the gut microbiota.

Countries

Spain

Contacts

CONTACTHéctor Guadalajara-Labajo, MD, PhD
h.guadalajara@quironsalud.es+ 34 550 4800
PRINCIPAL_INVESTIGATORMariano García-Arranz, PhD

Health Research Institute Fundación Jiménez Díaz

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026