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

NCT07416760 | Recruiting

• 1 other identifier: PIC165-25_FJD
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Surgery

Keywords

Microbiome; intestinal anastomosis; dehiscence

Outcome Measures

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.

  From enrollment to a month post surgery

Secondary Outcomes (1)

• Predictive indicators of colorectal anastomosis postsurgery

  From surgery to a month

Study Arms (1)

Patients undergoing abdominal surgery with intestinal anastomosis

Older than 18 years of age

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

Fecal sample collection

Patients undergoing abdominal surgery with intestinal anastomosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

University Hospital Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

Related Publications (9)

• Jørgensen AB, Almer L, Brandstrup B, Friis-Hansen L. Fecal microbiomes from screening sampling tubes are stable despite varying sampling and storage conditions. Sci Rep. 2025 Jul 24;15(1):26951. doi: 10.1038/s41598-025-12506-5.

  BACKGROUND

• Hajjar R, Richard C, Santos MM. The gut barrier as a gatekeeper in colorectal cancer treatment. Oncotarget. 2024 Aug 14;15:562-572. doi: 10.18632/oncotarget.28634.

  BACKGROUND

• Lianos GD, Frountzas M, Kyrochristou ID, Sakarellos P, Tatsis V, Kyrochristou GD, Bali CD, Gazouli M, Mitsis M, Schizas D. What Is the Role of the Gut Microbiota in Anastomotic Leakage After Colorectal Resection? A Scoping Review of Clinical and Experimental Studies. J Clin Med. 2024 Nov 5;13(22):6634. doi: 10.3390/jcm13226634.

  BACKGROUND

• Hoedt EC, Carroll GM, Stephensen BD, Morrison M, Vishnoi V, Cuskelly A, Draganic BD, McManus B, Clarke L, Shah KH, Smith SR, Talley NJ, Keely S, Pockney P. Preoperative Antibiotics and Mechanical Bowel Preparation Impact the Colonic Mucosa-Associated Microbiota but Not Anastomotic Leak Rate After Colorectal Resection. Dis Colon Rectum. 2025 Jul 1;68(7):875-886. doi: 10.1097/DCR.0000000000003775

  BACKGROUND

• Xiong Z, Liu J, Chen L, Yang Y, Zhao S. Precision leak detection in the golden window: emerging biomarker strategies for anastomotic integrity monitoring after low anterior resection. Int J Surg. 2025 Oct 1;111(10):7125-7134. doi: 10.1097/JS9.0000000000002891

  BACKGROUND

• Ma K, Gu T, Wu Z, Li Z. Mechanisms of anastomotic leakage in colorectal cancer surgery: unraveling the roles of inflammation, immunity, and microbiota - a narrative review. Int J Surg. 2025 Aug 7. doi: 10.1097/JS9.0000000000003151

  BACKGROUND

• Barat B, Shogan BD. The Microbiome's Role in Driving Anastomotic Leak and Cancer Recurrence Following Colorectal Surgery. Surg Clin North Am. 2025 Oct;105(5):953-964. doi: 10.1016/j.suc.2025.06.003.

  BACKGROUND

• van Praagh JB, de Goffau MC, Bakker IS, Harmsen HJ, Olinga P, Havenga K. Intestinal microbiota and anastomotic leakage of stapled colorectal anastomoses: a pilot study. Surg Endosc. 2016 Jun;30(6):2259-65. doi: 10.1007/s00464-015-4508-z. Epub 2015 Sep 18. PMID: 26385781

  BACKGROUND

• Yan J, Wang Q, Li Q, Lu J, Tong Q. Differences in gut microbiota among patients with anastomotic leak following colorectal cancer surgery. Front Microbiol. 2025 Oct 6;16:1578990. doi: 10.3389/fmicb.2025.1578990. PMID: 41122462;

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial DNA in feces

Study Officials

• Mariano García-Arranz, PhD

  Health Research Institute Fundación Jiménez Díaz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Héctor Guadalajara-Labajo, MD, PhD

CONTACT

+ 34 550 4800; h.guadalajara@quironsalud.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Biochemistry and Molecular Biology

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: February 18, 2026
• Study Start: February 14, 2026
• Primary Completion: February 14, 2026
• Study Completion (Estimated): December 14, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Between 6-12 months
• Access Criteria: Open access

Locations

ES (1)