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| Name | Class |
|---|---|
| University of Debrecen | OTHER |
| Csolnoky Ferenc Hospital | UNKNOWN |
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The microbiome, the collection of microorganisms that live in our gut, plays an important role in maintaining our health, proper nutrient absorption, nutrient turnover and immunity. After birth, a symbiotic relationship develops with the strains of bacteria that colonise our gut, and the presence and proportion of bacteria is individualised and highly variable.
A healthy bacterial flora is essential for the cells of the intestinal mucosa. Glycoproteins in the cell surface mucus coat are important nutrients for bacteria, while some bacterial strains supply mucosal cells with nutrient molecules (e.g. short-chain fatty acids) that are their essential energy source.
An abnormal change in the proportion of bacterial strains that make up the microbiome, dysbacteriosis, in which pathogenic bacteria proliferate at the expense of members of the normal flora, can cause a number of pathologies. Nutrient supply to the cells of the mucosa is reduced, making them more vulnerable and leading to various pathological conditions.
The microbiome and the essential nutrients they produce have also been found to play an important role in wound healing. A decrease in the diversity of the microbiome, an increase in the relative number of pathogenic bacteria and a decrease in the proportion of 'beneficial' bacteria increases the risk of surgical complications of infection and suture failure.
A number of risk factors have been identified that increase or decrease the risk of anastomotic leak. The risk of anastomotic failure is increased by anastomosis (lower third) close to the anus, tumour size greater than 5cm in colorectal carcinoma, surgical complications, smoking, diabetes, male gender, overweight, malnutrition (protein deficiency), heart disease requiring anticoagulation, time to surgery, American Society of Anaesthesiologist score, neoadjuvant treatment, corticosteroid use. The risk of suture failure is reduced by mechanical lining, intravenous and oral non-absorbable antibiotics. The microbiome also appears to have an impact on suture failure: lower diversity of bacteria in intraoperative specimens and an increase in the number of mucin-degrading Bacteroidaceae or Lachnospiraceae strains may be associated with higher anastomotic failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Antibiotic Prophylaxis + | At the Uzsoki Hospital and the Department of Surgery at the University of Debrecen, patients receive preoperative neomycin- metronidazole oral antibiotic prophylaxis in addition to mechanical bowel preparation. |
| |
| Oral Antibiotic Prophylaxis - | Patients admitted to the Csolnoky Ferenc Hospital in Veszprém will receive preoperative mechanical bowel preparation and no oral antibiotic prophylaxis. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neomycin Sulfate | Drug | Postoperative day-1 Oral Antibiotic Prophylaxis + patients get po. 3x1000mg Neomycin sulfate and 3x500 mg Metronidazole |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome | Is there evidence of a correlation between septic complications and the microbiome? | postoperative 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Affecting factors on microbiome | Is it a relevant factor influencing the microbiome: comorbidities, previous operations, oral antibiotic prophylaxis, systemic intravenous prophylaxis? | postoperative 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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All patients undergoing planned colorectal surgery, whether open or laparoscopic, with circular suture anastomosis training are eligible for the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Géza Papp, MD | Contact | +36302121102 | papp.geza@uzsoki.hu | |
| Attila Bursics, MD PhD | Contact | abursics@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Peter Bay, Prof. | University of Debrecen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uzsoki Hospital | Recruiting | Budapest | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31320106 | Background | Hajjar R, Santos MM, Dagbert F, Richard CS. Current evidence on the relation between gut microbiota and intestinal anastomotic leak in colorectal surgery. Am J Surg. 2019 Nov;218(5):1000-1007. doi: 10.1016/j.amjsurg.2019.07.001. Epub 2019 Jul 11. | |
| 29303807 | Background | van Praagh JB, de Goffau MC, Bakker IS, van Goor H, Harmsen HJM, Olinga P, Havenga K. Mucus Microbiome of Anastomotic Tissue During Surgery Has Predictive Value for Colorectal Anastomotic Leakage. Ann Surg. 2019 May;269(5):911-916. doi: 10.1097/SLA.0000000000002651. |
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| ID | Term |
|---|---|
| D057868 | Anastomotic Leak |
| D003141 | Communicable Diseases |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D009355 | Neomycin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009593 | Nitroimidazoles |
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Anastomotic ring full thickness colonic wall
|
| University of Debrecen | Not yet recruiting | Debrecen | Hungary |
|
| Csolnoky Ferenc Kórház | Not yet recruiting | Veszprém | Hungary |
|
| 29341151 | Background | Gaines S, Shao C, Hyman N, Alverdy JC. Gut microbiome influences on anastomotic leak and recurrence rates following colorectal cancer surgery. Br J Surg. 2018 Jan;105(2):e131-e141. doi: 10.1002/bjs.10760. |
| 30858400 | Background | Nagata N, Tohya M, Fukuda S, Suda W, Nishijima S, Takeuchi F, Ohsugi M, Tsujimoto T, Nakamura T, Shimomura A, Yanagisawa N, Hisada Y, Watanabe K, Imbe K, Akiyama J, Mizokami M, Miyoshi-Akiyama T, Uemura N, Hattori M. Effects of bowel preparation on the human gut microbiome and metabolome. Sci Rep. 2019 Mar 11;9(1):4042. doi: 10.1038/s41598-019-40182-9. |
| 33793743 | Background | Papp G, Saftics G, Szabo BE, Baracs J, Vereczkei A, Kollar D, Olah A, Meszaros P, Duboczki Z, Bursics A. Systemic versus Oral and Systemic Antibiotic Prophylaxis (SOAP) study in colorectal surgery: prospective randomized multicentre trial. Br J Surg. 2021 Apr 5;108(3):271-276. doi: 10.1093/bjs/znaa131. |
| 34853567 | Background | Williamson AJ, Alverdy JC. Influence of the Microbiome on Anastomotic Leak. Clin Colon Rectal Surg. 2021 Nov 23;34(6):439-446. doi: 10.1055/s-0041-1735276. eCollection 2021 Nov. |
| 29608151 | Background | Di Segni A, Braun T, BenShoshan M, Farage Barhom S, Glick Saar E, Cesarkas K, Squires JE, Keller N, Haberman Y. Guided Protocol for Fecal Microbial Characterization by 16S rRNA-Amplicon Sequencing. J Vis Exp. 2018 Mar 19;(133):56845. doi: 10.3791/56845. |
| 35998096 | Background | Reuvers JRD, Budding AE, van Egmond M, Stockmann HBAC, Twisk JWR, Kazemier G, Abis GSA, Oosterling SJ; SELECT trial group. Gut Proteobacteria levels and colorectal surgical infections: SELECT trial. Br J Surg. 2023 Jan 10;110(2):129-132. doi: 10.1093/bjs/znac288. No abstract available. |
| D020969 | Disease Attributes |
| D014946 | Wound Infection |
| D009574 |
| Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |