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New treatment option for Postoperative Ileus
Official title Use of Beetroot Juice to Protect Against Postoperative Ileus Following Colorectal Surgery: BEET IT Study
ClinicalTrials.gov ID: NCT05133024
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients undergoing elective colonic and upper rectum laparoscopic surgery requiring an anastomosis, without the need of conversion
You likely can't join if
- 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
See the full eligibility criteria
- Adult patients undergoing elective colonic and upper rectum laparoscopic surgery requiring an anastomosis, without the need of conversion
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Edegem, Belgium
- Genk, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Sint-Niklaas, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edegem, Belgium; Genk, Belgium; Ghent, Belgium; Leuven, Belgium; Sint-Niklaas, Belgium. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.