Perioperative selective decontamination of the digestive tract (SDD) in elective colorectal cancer patients: a multicenter randomized clinical trial

Phase 3

Completed

Conditions: bowel cancer and anastomotic leakage after surgery
Colorectal cancer
10017990
10017991

Registration Number: NL-OMON44116

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

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

Exclusion Criteria

* Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
* A history of colorectal malignancy
* Current malignancy now undergoing treatment
* Previous surgery for diverticulitis / diverticulosis
* Performance status ASA 4 or higher (American Society of Anaesthesiologists)
* Expected reactions / allergies to the study medication
* Reversal of a temporary colostomy or ileostomy
* Prednisone use of more than 5 mg per day
* Familial adenomatous polyposis coli (FAP, Lynch syndrome), Hereditary Non Polyposis Colorectal Cancer (HNPCC)
* Inability to give informed consent
* Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the SELECT trial is anastomotic leakage, which is<br /><br>defined as clinical and/or radiological evidence of anastomotic dehiscence<br /><br>requiring surgical or radiological (re)intervention. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are other postoperative infectious complications (including<br /><br>pneumonia, urinary tract infections, surgical site infections, wound<br /><br>dehiscence), in-hospital mortality, readmission rate, reoperation rate,<br /><br>duration of hospital stay, quality of life, in-hospital and out-of-hospital<br /><br>costs. Moreover, disease free survival is evaluated at 3 and 5 years. </p><br>