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Recruiting NCT07416760

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

— Observational Abdominal Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Not applicable- observational study.
Who it may be relevant to
Registry conditions: Abdominal Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other Not applicable- observational study
    Fecal sample collection

Primary outcome measures

  • Understand the patient's microbiome [Time frame: From enrollment to a month post surgery]
Secondary outcome measures (1)
  • Predictive indicators of colorectal anastomosis postsurgery [Time frame: From surgery to a month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • University Hospital Fundación Jiménez Díaz — Madrid

Publications

  • Jorgensen 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. PMID 40707563
  • 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. PMID 39145528
  • 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. PMID 39597778
  • 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. E PMID 40214103
  • 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. Epub 2025 Jun 25. PMID 40561163
  • 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 Dec 1;111(12):9482-9495. doi: 10.1097/JS9.0000000000003151. Epub 2025 Aug 6. PMID 40773274
  • 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. Epub 2025 Jul 28. PMID 41077437
  • 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

Identifiers

NCT: NCT07416760 · PIC165-25_FJD · PIC165-25_FJD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗