SURGIcal COmplication and MIcrobiome ChangeS in Colorectal Surgery

NCT05779254 | Unknown

• 1 other identifier: Surgi-Comics_01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Anastomotic Leak; Microbial Colonization

Keywords

Colorectal surgery; Anastomotic leak; Surgical site infection; Microbiome; Oral antibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

• Microbiome

  Is there evidence of a correlation between septic complications and the microbiome?

  postoperative 30 days

Secondary Outcomes (1)

• Affecting factors on microbiome

  postoperative 30 days

Study Arms (2)

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.

Drug: Neomycin Sulfate

Oral Antibiotic Prophylaxis -

Patients admitted to the Csolnoky Ferenc Hospital in Veszprém will receive preoperative mechanical bowel preparation and no oral antibiotic prophylaxis.

Interventions

Neomycin Sulfate DRUG

Postoperative day-1 Oral Antibiotic Prophylaxis + patients get po. 3x1000mg Neomycin sulfate and 3x500 mg Metronidazole

Also known as: Metronidazole

Oral Antibiotic Prophylaxis +

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients undergoing planned colorectal surgery, whether open or laparoscopic, with circular suture anastomosis training are eligible for the study.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Uzsoki Hospital: lead
• University of Debrecen: collaborator
• Csolnoky Ferenc Hospital: collaborator

Study Sites (3)

Uzsoki Hospital

Budapest, Hungary

RECRUITING

University of Debrecen

Debrecen, Hungary

NOT YET RECRUITING

Csolnoky Ferenc Kórház

Veszprém, Hungary

NOT YET RECRUITING

Related Publications (8)

• 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.

  PMID: 31320106 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.

  PMID: 29303807 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.

  PMID: 29341151 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.

  PMID: 30858400 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.

  PMID: 33793743 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.

  PMID: 34853567 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.

  PMID: 29608151 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.

  PMID: 35998096 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Anastomotic ring full thickness colonic wall

MeSH Terms

Conditions

Anastomotic Leak; Communicable Diseases; Surgical Wound Infection

Interventions

Neomycin; Metronidazole

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Disease Attributes; Wound Infection

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Peter Bay, Prof.

  University of Debrecen

  STUDY DIRECTOR

Central Study Contacts

Géza Papp, MD

CONTACT

+36302121102; papp.geza@uzsoki.hu

Attila Bursics, MD PhD

CONTACT

abursics@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: March 22, 2023
• Study Start: February 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2026
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

HU (3)