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| ID | Type | Description | Link |
|---|---|---|---|
| PIC165-25_FJD | Other Identifier | Clinical Research Ethics Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing abdominal surgery with intestinal anastomosis | Older than 18 years of age |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable- observational study | Other | Fecal sample collection |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive indicators of colorectal anastomosis postsurgery | Predictive indicators of postoperative outcomes in patients undergoing colorectal anastomosis surgery through metagenomic characterization of the gut microbiota. | From surgery to a month |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Héctor Guadalajara-Labajo, MD, PhD | Contact | + 34 550 4800 | 4331 | h.guadalajara@quironsalud.es |
| Name | Affiliation | Role |
|---|---|---|
| Mariano García-Arranz, PhD | Health Research Institute Fundación Jiménez Díaz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Fundación Jiménez Díaz | Recruiting | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40707563 | Background | 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. | |
| 39145528 | 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. |
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Publication of results in open access. Presentation at national surgery conferences.
Between 6-12 months
Open access
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Sep 19, 2025 | Feb 13, 2026 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 19, 2025 | Feb 13, 2026 | SAP_001.pdf |
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Bacterial DNA in feces
| 39597778 | 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. |
| 40214103 | 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. Epub 2025 Apr 11. |
| 40561163 | 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. Epub 2025 Jun 25. |
| 40773274 | 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 Dec 1;111(12):9482-9495. doi: 10.1097/JS9.0000000000003151. Epub 2025 Aug 6. |
| 41077437 | 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. Epub 2025 Jul 28. |
| 26385781 | 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. |
| 41122462 | 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. eCollection 2025. |