About this trial
The goal of the BEET IT study is to examine if preoperative intake of beetroot juice can ameliorate gastrointestinal (GI) recovery after colorectal surgery and thereby help to reduce the duration of postoperative ileus (POI) and prevent prolonged POI. Adult patients undergoing laparoscopic colorectal surgery are randomized 1:1 to consume either concentrated beetroot juice (active intervention) or nitrate-depleted concentrated beetroot juice (placebo) during the week before their surgery. Blood, tissue and/or fecal samples are collected at specific time points pre- and/or postoperatively to study markers related to inflammation, oxidative stress and GI function. Patients are followed from the week before surgery (start of the intervention) until 3 months post-surgery. The study takes place at 5 hospitals in Flanders, Belgium.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients undergoing elective colonic and upper rectum laparoscopic surgery requiring an anastomosis, without the need of conversion
Disqualifiers
< 18 years of age
Pregnancy or breast feeding
Psychiatric pathology capable of affecting comprehension and judgment faculty
History of inflammatory bowel disease
Trial design
Parallel
Treatments tested in this trial
concentrated beetroot juice
Dietary supplementNitrate supplementation; natural source of dietary nitrate
Treatment groups
Trial outcomes
Primary outcomes
Postoperative recovery of gastrointestinal (GI) function
composite endpoint requiring recovery of both upper GI functions (tolerance of a solid diet) and lower GI functions (passage of flatus and stool)
Secondary outcomes
First passage of flatus
recorded in postoperative days (standard of care) and hours (self-reported in the patient diary)
First passage of stool
recorded in postoperative days (standard of care) and hours (self-reported in the patient diary)
First tolerance of liquids
liquids: no chewing required, can be quickly swallowed as such, can be ingested with a straw (e.g. water, coffee, tea, juice, soda), recorded in postoperative days (standard of care) and hours (self-reported in the patient diary)
First tolerance of a semi-solid diet
semi-solid food: no or limited biting and chewing required, can be easily swallowed, usually ingested with a spoon or fork (e.g. yoghurt, eggs, soft cheeses), recorded in postoperative days (standard of care) and hours (self-reported in the patient diary)
Sponsors and contacts
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University Hospital, Ghent
Lead sponsor
Research Foundation Flanders
Collaborator