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The influence of the intestinal microbiome on the development of postoperative complications after elective colon surgery - a prospective cohort study

The influence of the intestinal microbiome on the development of postoperative complications after elective colon surgery - a prospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00014059
Enrollment
148
Registered
2018-02-21
Start date
2018-04-11
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K91.83 T79.3

Interventions

Group 1: Patients of full age, who underwent colonic surgery at the Department of General and Visceral Surgery, who were not scheduled to have a stoma and who developed complications (according to the

Sponsors

Universitätsklinikum FreiburgInstitut für Umweltmedizin und KrankenhaushygieneUni-Zentrum Naturheilkunde
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Conservative and elective surgery, colon surgery (left hemicolectomy, right hemicolectomy, sigmoid resection, deep anterior rectal resection, continuity restoration), maintenance of continuity (physiological bowel transit with regular defecation is possible), no antibiotic or probiotic therapy at least four weeks prior to surgery, no long term therapy with opiates, no permanent use of antiemetics or intestinal stimulants (the single use of a laxative, for example, to prepare for a colonoscopy is not an exclusion criterion)

Exclusion criteria

Exclusion criteria: Emergency surgery, creation of a terminal or protective anus praeter, no physiological nutritional passage (from oral to anal) possible, antibiotic pretreatment must have been completed at least four weeks prior to surgery, inability to pass stool sample, inability to complete a questionnaire, lack of compliance and participation carrying out the study, unresponsive

Design outcomes

Primary

MeasureTime frame
Difference in intestinal microbiome diversity (measured preoperatively and on the 6th postoperative day) between patients with complication-rich and patients with complication-free course as measured by Shannon's index after sequence analysis of a stool sample

Secondary

MeasureTime frame
Correlation of systemic inflammatory parameters (number of leukocytes, concentration of CRP, measured preoperatively and on the 3rd, 6th and 9th postoperative days) and parameters of intestinal permeability (zonulin, measured preoperatively and on the 3rd and 6th postoperative days) with the changes intestinal microbiome when complication occurs; Change in quality of life (measured by MDBF preoperatively and on the 3rd, 6th and 9th postoperative days) after colon surgery in relation to the intestinal microbiome Change in the diversity of the microbiological spectrum of the intestine after colorectal resections (patient-specific comparison of preoperative to the 6th postoperative day); Analysis and comparison of subgroups such as overweight patients (BMI> 30 kg / m2), older patients (> 70 years) and patients with previous abdominal operations; Subgroup analysis of patients who have a deviation from the standard concept defined in the curriculum; Connection of the microbiome in the drainage secretion (taken immediately after the complication has occurred and processed by means of sequence analysis) of patients with anastomotic leakage to the microbiome of the stool of the affected patients; Correlation of individual bacterial strains with the postoperative complications

Countries

Germany

Contacts

Public ContactAnn-Kathrin Lederer

Universitätsklinikum FreiburgInstitut für Umweltmedizin und KrankenhaushygieneUni-Zentrum Naturheilkunde

ann-kathrin.lederer@uniklinik-freiburg.de0761 / 27082010

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026