Use of Beetroot Juice to Protect Against Postoperative Ileus Following Colorectal Surgery: BEET IT Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • concentrated beetroot juice

    Dietary supplement

    Nitrate supplementation; natural source of dietary nitrate

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: beetroot juiceActive comparator 1 intervention
Group B: nitrate-depleted beetroot juicePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
hours after the end of surgery (suture)

Secondary outcomes

1

First passage of flatus

recorded in postoperative days (standard of care) and hours (self-reported in the patient diary)

Time frame
first occurence after the end of surgery (suture)
2

First passage of stool

recorded in postoperative days (standard of care) and hours (self-reported in the patient diary)

Time frame
first occurence after the end of surgery (suture)
3

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)

Time frame
first occurence after the end of surgery (suture)
4

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)

Time frame
first occurence after the end of surgery (suture)

Other outcomes

Sponsors and contacts

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University Hospital, Ghent

Lead sponsor

Research Foundation Flanders

Collaborator