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Selective oral decontamination of the esophagus to reduce microbial burden among patients with esophageal cancer

Selective oral decontamination of the esophagus to reduce microbial burden among patients with esophageal cancer - SODA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00028553
Enrollment
10
Registered
2023-02-21
Start date
2026-12-31
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Esophageal Cancer

Interventions

Group 1: Selective oral decontamination of the esophagus 7 days prior to operation, intraoperatively and 5 days postoperatively.

Sponsors

Universitätsklinikum Halle (Saale)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Patients =18 years • Histologically confirmed esophageal squamous cell or adenocarcinoma • Planned elective esophagectomy with intrathoracic anastomosis

Exclusion criteria

Exclusion criteria: • Patients <18 years • Complete dysphagia with inability to orally ingest the study drug • Known allergies or intolerances against the above-mentioned drugs • Inability to provide informed consent.

Design outcomes

Primary

MeasureTime frame
Infectious complications after esophageal resection (composite of pneumonia, anastomotic leakage, empyema, mediastinitis, surgical site infection in hospital / 30 day, whatever is longer)

Secondary

MeasureTime frame
• Overall postoperative morbidity (in hospital / 30 day, whatever is longer) • Postoperative mortality (in hospital / 30 day, whatever is longer) • Adverse events attributed to the intervention • Time to full oral diet • Length of hospital stay • Overall and esophagus-specific quality of life (FACT-E questionnaire) • Changes in the esophageal microbiome

Countries

Germany

Contacts

Public ContactJohannes Klose

Universitätsklinikum Halle (Saale)

Johannes.Klose@uk-halle.de+49 345 557 3229

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026