BEET IT: Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.

Sponsor

University Hospital, Ghent (Other)

Overall Status

Unknown status

CT.gov ID

NCT03772444

Collaborator

University Ghent (Other)

Enrollment

Location

Arms

23.5

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The BEET IT study investigates the possible protective effect of beetroot juice on POI following colorectal surgery in (partially) blinded single-center phase 2 randomized trial (pilot study).

Condition or Disease	Intervention/Treatment	Phase
Postoperative Ileus	Dietary Supplement: Beetroot juice Dietary Supplement: Nitrate-depleted beetroot juice Dietary Supplement: Water	N/A

Detailed Description

Postoperative ileus (POI) is a transient impairment of gastrointestinal motility following abdominal surgery, which leads to increased morbidity, prolonged hospitalization and increased healthcare cost. The pathogenesis of POI involves inflammation and oxidative stress, similar to ischemia/reperfusion injury that can be counteracted with beetroot juice. Beetroot juice is a source of inorganic nitrate, which by conversion of nitrate to nitrite in the body, exerts its protective effect. We before demonstrated in a preclinical model that administration of exogenous nitrite was shown to protect against POI. The aim of this pilot study is to investigate the possible protective effect of beetroot juice ingestion on POI following colorectal surgery.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

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.

Primary Purpose:

Prevention

Official Title:

Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.

Actual Study Start Date :

Jan 15, 2018

Anticipated Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Time until recovery of gastrointestinal function. [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.

Secondary Outcome Measures

Time until passage of stool, flatus or until tolerance of (semi-)solid oral diet (in days). [up to 30 days after surgery]
Overall post-operative complication rate defined according to the Clavien-Dindo Classification. [3 months postoperatively]
Presence of prolonged postoperative ileus. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

• All patients undergoing colonic or upper rectum laparoscopic surgery.

Exclusion Criteria:

Pregnancy or breast feeding
Psychiatric pathology capable of affecting comprehension and judgment faculty
History of metastatic disease
History of prior abdominal bowel surgery
Abdominal radiation treatment
Chronic constipation (defined as two or fewer bowel movements per week)
Gut motility influencing agents (e.g. tricyclic antidepressants, chronic use of laxatives)
Frequent use of mouthwash, as this affects the enterosalivary circulation of nitrate
Current use of broad-spectrum antibiotics, which will affect the oral flora and likely affect the nitrate reductase activity
More than one bowel anastomosis during this surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghent University Hospital	Gent		Belgium	9000

Sponsors and Collaborators

University Hospital, Ghent
University Ghent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GIHeelkunde, Prof. Dr. Wim Ceelen, University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT03772444

Other Study ID Numbers:

EC/2017/1476

First Posted:

Dec 11, 2018

Last Update Posted:

Dec 13, 2018

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ileus

Study Results

No Results Posted as of Dec 13, 2018