Impact of Microbiome Changes on Surgical Complications in Colorectal Surgery
Analysis of Mechanism on the Efficacy of Oral Antibiotic Prophylaxis in Elective Colon and Rectal Surgery With Primary Anastomosis
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uzsoki Hospital Academic / other |
| Locations | 3 sites (Budapest and 2 other locations) |
| Trial ID | NCT05779254 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults scheduled for colorectal surgery with planned circular stapled anastomosis who are not allergic to antibiotics.
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.
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 performed: While the specific approach of this study is novel, previous research has indicated that microbiome diversity can impact surgical outcomes, suggesting potential for success.
Eligibility criteria
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 this trial is running
Budapest and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.