Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study. (BEET IT)
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|ClinicalTrials.gov Identifier: NCT03772444|
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : December 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Ileus||Dietary Supplement: Beetroot juice Dietary Supplement: Nitrate-depleted beetroot juice Dietary Supplement: Water||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Patients undergoing colorectal surgery will be randomized (n=10) to receive one week daily 70 ml of beetroot juice (~ 7 mmol inorganic nitrate) or (n=10) an equivalent volume of nitrate-depleted beetroot juice (control group 1). An additional control group (n=10) is added to the pilot study, in which patients will receive an equivalent volume of water (control group 2); this allows us to investigate whether the antioxidants present in beetroot juice contribute to the protective effect of beetroot juice in POI. Beetroot juice and nitrate-depleted beetroot juice cause discoloration of urine (beeturia) and feces from the purple betacyanin pigments in beetroot; for the control group that receives water, this will not be the case and blinding for this group is thus not possible.|
|Official Title:||Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.|
|Actual Study Start Date :||January 15, 2018|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||January 1, 2020|
|Active Comparator: Beetroot juice||
Dietary Supplement: Beetroot juice
Patients will drink 70 ml of beetroot juice daily in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.
|Placebo Comparator: Control group 1||
Dietary Supplement: Nitrate-depleted beetroot juice
Patients will drink 70 ml of nitrate-depleted beetroot juice daily in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.
|Sham Comparator: Control group 2||
Dietary Supplement: Water
Patients will drink 70 ml of water in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.
- Time until recovery of gastrointestinal function. [ Time Frame: up to 30 days after surgery ]Recovery of gastrointestinal function is defined as the interval (in days) from the end of surgery until passage of stool AND tolerance of solid food.
- Time until passage of stool, flatus or until tolerance of (semi-)solid oral diet (in days). [ Time Frame: up to 30 days after surgery ]
- Overall post-operative complication rate defined according to the Clavien-Dindo Classification. [ Time Frame: 3 months postoperatively ]
- Presence of prolonged postoperative ileus. [ Time Frame: up to 30 days after surgery ]Prolonged postoperative ileus is defined as presence of 2 or more of the following criteria on or after day 4 postoperatively: nausea or vomiting, inability to tolerate a solid or semi-solid oral diet, abdominal distension, absence of flatus and stool, radiological evidence of ileus.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772444
|Contact: Wim Ceelen||+32(0)email@example.com|
|Contact: Sarah Cosyns||+32(0)firstname.lastname@example.org|
|Ghent University Hospital||Recruiting|
|Gent, Belgium, 9000|
|Contact: Wim Ceelen +32(0)93326251 email@example.com|
|Sub-Investigator: Sarah Cosyns|