RecruitingPhase 2

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

Belgium170 participantsStarted 2021-03-31

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients undergoing elective colonic and upper rectum laparoscopic surgery requiring an anastomosis, without the need of conversion Exclusion Criteria: General: * \< 18 years of age * Pregnancy or breast feeding Medical: * Psychiatric pathology capable of affecting comprehension and judgment faculty * History of inflammatory bowel disease * Chronic vascular disease affecting the intestines * Chronic constipation (\<= 2 bowel movements/week) * Previous abdominal or pelvic radiation treatment * Recent (\< 3 months before inclusion) or current intra-abdominal infection or inflammation (e.g. diverticulitis, appendicitis, cholecystitis) * Use of gut motility influencing agents (e.g. tricyclic antidepressants, chronic use of laxatives) * Use of nitrates (e.g. isosorbide dinitrate, nitroglycerin), including daily consumption of beetroot juice (unless stopped for a month prior to the intervention period) * Hypotension (\< 100/60 mmHg) * Uncontrolled diabetes mellitus * Renal or hepatic insufficiency * Known allergies or intolerances to beetroot, nitrates/nitrites * Enrollment in other clinical trials/experiments, unless approved by the Ethics Committee(s) Surgical: * History of prior colorectal surgery * Emergency surgery * Open surgery * Colorectal surgery not requiring an anastomosis (e.g. colotomy, wedge resection) * More than 1 bowel anastomosis planned * Concomitant surgical procedures required (e.g. resection of liver or lung metastases) * Pr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative recovery of gastrointestinal (GI) function

Timeframe: hours after the end of surgery (suture)

Trial details

NCT IDNCT05133024

SponsorUniversity Hospital, Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Wim Ceelen, MD, PhD

093326251 wim.ceelen@ugent.be

View on ClinicalTrials.gov More Postoperative Ileus trials