Impact of Microbiome Changes on Surgical Complications in Colorectal Surgery
Official title: Analysis of Mechanism on the Efficacy of Oral Antibiotic Prophylaxis in Elective Colon and Rectal Surgery With Primary Anastomosis
Run by Uzsoki Hospital · NCT05779254 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is trying to see if changes in gut bacteria affect the risk of complications after colorectal surgery, especially for patients having a specific type of surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Uzsoki Hospital Academic / other |
| Locations | 3 sites (Budapest and 2 other locations) |
| Trial ID | NCT05779254 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults scheduled for colorectal surgery with planned circular stapled anastomosis who are not allergic to antibiotics.
✕Probably not a fit
Patients who have received antibiotics within two weeks prior to the study or those with chronic immunosuppression may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the relationship between the microbiome and surgical complications, specifically focusing on anastomotic leaks in colorectal surgery. It examines how variations in gut bacteria may influence surgical outcomes, particularly in patients undergoing circular stapled anastomosis. The study will involve administering neomycin sulfate as part of the bowel preparation process and analyzing intraoperative specimens for bacterial diversity. By understanding these dynamics, the research aims to identify risk factors associated with anastomotic failure and improve surgical techniques.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced rates of complications for patients undergoing colorectal surgery.
How similar studies have gone: While the specific approach of this study is novel, previous research has indicated that microbiome diversity can impact surgical outcomes, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Circular stapled anastomosis * Planned surgery with colo-colic anastomosis * No passage disorder, as it is confirmed at the first medical examination * Not allergic to antibiotics * Can receive a bowel preparation * No proximal excluded intestine, i.e., the bowel preparation may be successful (ileostomy) Exclusion Criteria: * treated with antibiotics within 2 weeks before randomisation * allergic to any of the medicines used * under 18 years of age * have suffered from abdominal sepsis within 6 months prior to recruitment * pregnancy or breastfeeding * been treated with steroids * any form of chronic immunosuppression
Where it's running
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Uzsoki Hospital
Budapest, Hungary Recruiting -
University of Debrecen
Debrecen, Hungary Not yet recruiting -
Csolnoky Ferenc Kórház
Veszprém, Hungary Not yet recruiting
Study contacts
- Study coordinator: Géza Papp, MD
- Email: papp.geza@uzsoki.hu
- Phone: +36302121102
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using fingertip CRP point-of-care tests to spot leaks after elective colorectal surgery
This project will see if daily fingertip CRP point-of-care tests can detect anastomotic leaks early in people having elective colorectal surgery.
-
Gastric preconditioning before esophagectomy for patients at high risk of anastomotic leak
This registry will see if gastric preconditioning by percutaneous angioembolization before esophagectomy changes how often anastomotic leaks happen in people with esophageal cancer who are at high risk.
-
Bile acid and gut microbiota changes in people with hepatitis D starting bulevirtide
This project will see if starting bulevirtide changes bile acids and gut bacteria in adults with chronic hepatitis D who are already on hepatitis B therapy.
-
Signia circular stapler for left-sided colon, sigmoid, and rectal resections
This study will try the Signia circular stapler with Tri-Staple technology to see if it safely creates bowel reconnections in adults having left-sided colon, sigmoid, or rectal surgery.
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Causes and outcomes of anastomotic leaks after colorectal surgery
This project will try to identify which pre-, intra-, and post-operative factors predict anastomotic leakage and build a prediction model for adults having colorectal resection with bowel reconnection.
-
Leakage risk after ileo-colic sutures using MonoPlus® following right hemicolectomy
This will try MonoPlus® suture material for ileo-colic anastomosis in adults having elective right hemicolectomy for colon cancer to see if the 30-day leakage rate is not higher than published rates.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.