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

RecruitingPhase 2Ages 18 Years - anyAllUniversity Hospital, Ghent
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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) * Protective stoma planned
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What it tests

  • concentrated beetroot juice
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Where

6 sites
Antwerp University Hospital
Edegem, Belgium
Hospital East-Limburg
Genk, Belgium
AZ Sint-Lucas Ghent
Ghent, Belgium
Ghent University Hospital
Ghent, Belgium
University Hospital Leuven
Leuven, Belgium
VITAZ
Sint-Niklaas, Belgium
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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