Anastomotic LeakSurgi-ComicsNCT05779254
SURGIcal COmplication and MIcrobiome ChangeS in Colorectal Surgery
An observational study of Anastomotic Leak and Microbial Colonization, run by Uzsoki Hospital at 3 sites in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak, Microbial Colonization
- What is being tested?
- Neomycin Sulfate
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 3 sitesHungary
- Study dates
- 1 Feb 2023to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing planned colorectal surgery, whether open or laparoscopic, with circular suture anastomosis training are eligible for the study.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Attila Bursics, MD PhD contact
Hungary3 sites, 3 recruiting
- Recruiting
Uzsoki Hospital
Budapest
Géza Papp, MD, papp.geza@uzsoki.hu
Attila Bursics, MD PhD, bursics@uzsoki.hu
- Not yet recruiting
University of Debrecen
Debrecen
Péter Kolozsi, MD, drkolozsipeter@gmail.com
Dezső Tóth, Prof., detoth@gmail.com
- Not yet recruiting
Csolnoky Ferenc Kórház
Veszprém
Tibor Nagy, MD, surgnagy@gmail.com
Elemér Mohos, MD PhD, dr.mohose@gmail.com
About this study
Official title: Analysis of Mechanism on the Efficacy of Oral Antibiotic Prophylaxis in Elective Colon and Rectal Surgery With Primary Anastomosis
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Anastomotic Leak, Microbial Colonization
- Being tested
- Neomycin Sulfate
- Keywords
- Colorectal surgery, Anastomotic leak, Surgical site infection, Microbiome, Oral antibiotic prophylaxis
- Medical subject headings
- Anastomotic Leak, Communicable Diseases, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neomycin SulfateDrug
Also called Metronidazole
Postoperative day-1 Oral Antibiotic Prophylaxis + patients get po. 3x1000mg Neomycin sulfate and 3x500 mg Metronidazole
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome
Is there evidence of a correlation between septic complications and the microbiome?
Measured: postoperative 30 days
Secondary outcomes (1)
Affecting factors on microbiome
Is it a relevant factor influencing the microbiome: comorbidities, previous operations, oral antibiotic prophylaxis, systemic intravenous prophylaxis?
Measured: postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Feb 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anastomotic LeakStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uzsoki Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Debrecen, Csolnoky Ferenc Hospital
- Responsible party
- Principal investigator, Dr. Papp Géza, Uzsoki Hospital
- Investigators
- Peter Bay, Prof., Study director, University of Debrecen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779254
- Sponsor's protocol ID
- Surgi-Comics_01
- Acronym
- Surgi-Comics
- Status last verified
- Mar 2023
- First submitted
- 12 Feb 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31320106van 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.
PubMed 29303807Gaines 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.
PubMed 29341151Nagata 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.
PubMed 30858400Papp 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.
PubMed 33793743Williamson 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.
PubMed 34853567Di 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.
PubMed 29608151Reuvers 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.
PubMed 35998096
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Mechanism on the Efficacy of Oral Antibiotic Prophylaxis in Elective Colon and Rectal Surgery With Primary Anastomosis
- ClinicalTrials.gov ID
- NCT05779254
- Acronym / sponsor ID
- Surgi-Comics / Surgi-Comics_01
- Conditions
- Anastomotic Leak, Microbial Colonization
- Keywords
- Colorectal surgery, Anastomotic leak, Surgical site infection, Microbiome, Oral antibiotic prophylaxis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uzsoki HospitalUniversity, hospital or other
- Collaborators
- University of Debrecen, Csolnoky Ferenc Hospital
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Antibiotic Prophylaxis + | – | Drug: Neomycin SulfateAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing planned colorectal surgery, whether open or laparoscopic, with circular suture anastomosis training are eligible for the study.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neomycin SulfateAlso: MetronidazolePostoperative day-1 Oral Antibiotic Prophylaxis + patients get po. 3x1000mg Neomycin sulfate and 3x500 mg Metronidazole | Drug | Oral Antibiotic Prophylaxis + |
Primary outcome
Microbiome
Time frame: postoperative 30 days
Is there evidence of a correlation between septic complications and the microbiome?
1 secondary outcome
Affecting factors on microbiome
Time frame: postoperative 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Background: PubMed 31320106Hajjar 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.
- Background: PubMed 29303807van 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.
- Background: PubMed 29341151Gaines 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.
- Background: PubMed 30858400Nagata 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.
- Background: PubMed 33793743Papp 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.
- Background: PubMed 34853567Williamson 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.
- Background: PubMed 29608151Di 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.
- Background: PubMed 35998096Reuvers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Attila Bursics, MD PhD contact
Peter Bay, Prof. study director
University of Debrecen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leak and Microbial Colonization, run by Uzsoki Hospital at 3 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Géza Papp, MD (+36302121102, papp.geza@uzsoki.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome (time frame: postoperative 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05779254, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.