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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Emergency surgery.

Intra-abdominal sepsis or previous dehiscence.

Severe immunosuppression.

Use of antibiotics in the 3 months prior to preoperative preparation.

Trial population

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. To identify patients, the Surgery Department will analyze those who meet the inclusion and exclusion criteria designed for this project during the daily morning clinical session, and patients will then be offered the opportunity to accept/decline participation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Not applicable- observational study

    Other intervention

    Fecal sample collection

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Patients undergoing abdominal surgery with intestinal anastomosis1 intervention

Trial outcomes

Primary outcomes

1

Understand the patient's microbiome

To understand the microbiome of patients undergoing colorectal surgery and the effect of current surgical preparation on the microbiota in our local population.

Time frame
From enrollment to a month post surgery

Secondary outcomes

1

Predictive indicators of colorectal anastomosis postsurgery

Predictive indicators of postoperative outcomes in patients undergoing colorectal anastomosis surgery through metagenomic characterization of the gut microbiota.

Time frame
From surgery to a month

Other outcomes

Sponsors and contacts

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