Comparision of an extended preoperative antibiotic regimen with conventional antibiotics in patients undergoing colorectal surgery

The role of selective decontamination of the digestive tract in preventing surgical site infections in elective colorectal resections: a randomized controlled trial (SELDDEC Trial) - SELDDEC Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003670-14-IE

Enrollment

322

Registered

2017-09-29

Start date

2018-01-11

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Surgical Site Infection

Interventions

Trade Name: Neomycin Product Name: Neomycin Product Code: na Pharmaceutical Form: Tablet INN or Proposed INN: Neomycin CAS Number: 1404-04-2 Current Sponsor code: DB00994 Other descriptive name: NEO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients (aged = 18 years) scheduled for elective laparoscopic, open and robotic assisted colon or rectal surgery for benign or malignant disease will be eligible for inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 161 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 161

Exclusion criteria

Exclusion criteria: (1) inability to provide informed consent (2) acute surgery for bleeding, perforation or obstruction, (3) pregnancy or lactating, (4) uncontrolled diabetes mellitus, (5) preoperative steroid use, (6) antibiotic use within 2 weeks of proposed elective surgery date and (7) previous allergic reaction to the antibiotics utilised in this study.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary aim of this study is to evaluate the potential effect of preoperative selective decontamination of the digestive tract (SDD) in preventing surgical site infections (SSI) in patients undergoing elective open, laparoscopic and robotic colorectal surgery.;Secondary Objective: Secondary endpoints are infectious complications other than SSIs, length of hospital stay, postoperative complications as per Clavien Dindo Classification, anastomotic leakage where applicable and mortality.;Primary end point(s): The aim of the study is to determine whether a combination of preoperative SDD and single dose perioperative intravenous antibiotics reduces the incidence of postoperative complications compared to single dose perioperative intravenous antibiotics alone. The primary endpoint is the incidence of SSIs.;Timepoint(s) of evaluation of this end point: Patients will be reviewed in the outpatient clinic 4 weeks (30 days) following discharge.	—

Measure

Time frame

Main Objective: The primary aim of this study is to evaluate the potential effect of preoperative selective decontamination of the digestive tract (SDD) in preventing surgical site infections (SSI) in patients undergoing elective open, laparoscopic and robotic colorectal surgery.;Secondary Objective: Secondary endpoints are infectious complications other than SSIs, length of hospital stay, postoperative complications as per Clavien Dindo Classification, anastomotic leakage where applicable and mortality.;Primary end point(s): The aim of the study is to determine whether a combination of preoperative SDD and single dose perioperative intravenous antibiotics reduces the incidence of postoperative complications compared to single dose perioperative intravenous antibiotics alone. The primary endpoint is the incidence of SSIs.;Timepoint(s) of evaluation of this end point: Patients will be reviewed in the outpatient clinic 4 weeks (30 days) following discharge.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints are infectious complications other than SSIs, length of hospital stay, postoperative complications as per Clavien Dindo Classification, anastomotic leakage where applicable and mortality.;Timepoint(s) of evaluation of this end point: These data will be recorded upon patient discharge	—

Countries

Ireland

Contacts

Public ContactRishabh Sehgal

University Hospital Limerick

rishsehgal@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026