Does administration of antibiotics in patients undergoing surgery for colorectal cancer result in less complications and better prognosis?

Phase 1

• Conditions: Post-operative infective complications and long term oncological outcome in patients undergoing surgery for colorectal cancer; MedDRA version: 14.1Level: LLTClassification code 10059428Term: Postoperative infectionSystem Organ Class: 100000004862; MedDRA version: 14.1Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-002211-28-NL
• Lead Sponsor: VU medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-07
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 762

Inclusion Criteria

•Elective colon and rectal cancer surgery with primary anastomosis
•No evidence of distant metastases (preoperative CT-abdomen and X-thorax or CT-thorax)
•Procedure either with or without diverting stoma
•Both laparoscopic and open surgery
•Informed consent

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 762
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Previous colorectal surgery
•Inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
•Other malignancy
•Other malignancies in medical history
•Surgery for diverticular disease
•Performance status > ASA 3 (American Society for Anaesthesiologists)
•Expected adverse reactions/allergies for study medication
•Closure of temporary colostomy or ileostomy
•Immunocompromised patients (prednisone)
•Familial adenomatous polyposis coli (FAP; Lynch syndrome), Hereditary Non Polyposis Colorectal Cancer (HNPCC)
•Preoperative evidence of metastases
•Mental disorder/unable to give informed consent
•Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objectives of this randomized clinical trial are to evaluate if perioperative SDD can reduce anastomotic leakage rate and other infectious complications while thereby simultaneously improving long-term oncological outcome. ;Secondary Objective: Secondary objectives are a decline in reoperation rate, in-hospital mortality, readmission rate, duration of hospital stay and ICU admission, non-infectious complications, improvement of quality of life and reduction of costs.;Primary end point(s): The primary endpoint of the SELECT trial is anastomotic leakage and/or anastomotic abscess, defined as clinical and/or radiological evidence of anastomotic dehiscence requiring surgical or radiological (re)intervention. ;Timepoint(s) of evaluation of this end point: 6 weeks after the primary operation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The following secondary endpoints are formulated:<br><br>•Disease free survival at 3 and 5 years<br>•Other postoperative infectious complications including pneumonia, urinary tract infections, surgical site infections, wound dehiscence, (remote) intra-abdominal abscess<br>•Non-infectious complications including cardiac failure, cerebrovascular events, deep venous thrombosis<br>•In-hospital mortality <br>•Readmission rate<br>•Reoperation rate<br>•Duration of hospital stay <br>•Quality of life (quality adjusted life years) <br>•In hospital and out-of-hospital costs<br>;Timepoint(s) of evaluation of this end point: 6 weeks, 3 years and 5 years, depending on end point