CTRI/2018/07/014938.

Study name	Role of combined oral antibiotic and mechanical bowel preparation in reducing incidence of surgical site infections in comparison to only mechanical bowel preparation in patients undergoing elective resection for rectal cancer at a tertiary care centre in India: A Randomized Control Trial
Methods	Study type: interventional Study design Randomised, parallel group trial
Participants	Condition or disease: patients with rectal cancer Inclusion criteria Age 18‐80 years All patients with rectal/rectosigmoid cancer (based on MRI imaging), planned for surgical resection Exclusion criteria Patients with rectal cancer who are not eligible for mechanical bowel preparation/ where bowel preparation is contraindicated such as Crohn’s disease, obstructed bowel and renal or cardiac impairment.Also patients with known drug allergy to the medications used in the trial. Target sample size: 118
Interventions	Treatment arms Comparator Agent (Mechanical bowel preparation): 2 bottles of 45 mL of Exelyte bowel preparation solution (monobasic sodium phosphate dihydrate 24.417 g, disodium hydrogen orthophosphate dihydrate 5.439 g) to be consumed at 8 am and 4 pm on the day prior to surgery. Intervention (oral antibiotic bowel preparation): all the patients in this arm in addition to the bowel preparation solution (45 mL of Exelyte bowel preparation solution (monobasic sodium phosphate dihydrate 24.417 g, disodium hydrogen orthophosphate dihydrate 5.439 g) to be consumed at 8 am and 4 pm), will also receive 3 tablets each of, 1 g of Erythromycin Estolate and 400 mg of Metronidazole in the package, to be taken at 1pm, 2pm and 11 pm, on the day prior to surgery
Outcomes	Primary outcome To evaluate and assess the superiority of oral antibiotic bowel preparation in reducing incidence of surgical site infections in patients undergoing elective resection for rectal cancer in comparison to only mechanical bowel preparation at a tertiary care centre in India (within 30 days from the day of surgery) Secondary outcomes To assess the impact of antibiotic bowel preparation on post‐operative length of hospital stay (within 30 days from the day of surgery) To assess the impact of antibiotic bowel preparation on post‐operative morbidity (within 30 days from the day of surgery)
Starting date	Date of registration: 18/07/2018 Study Start Date: 25/04/2018 Study Completion Date: ‐ Recruitment Status: open to recruitment
Contact information	Contact person: Mark Ranjan Jesudason Affiliation: Christian Medical College, Vellore Country of origin: India
Notes	Ethics approval: Silver, Research and Ethics Committee, Christian Medical College, Vellore Source of funding: Fluid RFesearch Grant, Christian Medical College, Vellore