The Effects of Combined Gum-chewing and Parenteral Metoclopramide on Post-operative Ileus

NCT05669781 | Completed Phase 4

• 1 other identifier: UI/EC/18/0231
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

A delay in the return of bowel function is a common occurrence after abdominal surgeries.1 The goal of this study was to test the effect of the combined use of chewing a gum and administering metoclopramide intravenously on the duration of this natural delay in the return of bowel function after abdominal surgeries. Patients were grouped into four: the first group received both gum and metoclopramide; the second group received only gum; the third group received only metoclopramide, while the fourth group (the control group) received sterile water for injection. The groups were compared for the time taken for bowel function to return and the duration of hospital stay.

Conditions

Ileus Postoperative

Keywords

Gum-chewing; Metoclopramide; Abdominal; Surgery

Outcome Measures

Primary Outcomes (1)

• Duration of post-operative ileus

  Time to either the passage of flatus or feces, assessed every 8hours from post-operative day 1

  From 24 hours after surgery up to the time either flatus or feces is passed, for up to 1week after surgery

Secondary Outcomes (1)

• Duration of hospital stay

  First post-operative day up to the day of discharge, for up to 25days after surgery

Study Arms (4)

Gum-Metoclopramide

ACTIVE COMPARATOR

Intravenous metoclopramide 10mg 8hourly for the first 72hours post-operatively and to chew one a stick of sugar free gum (to be chewed over 15minutes) 8 hourly till either first flatus or feces was passed

Combination Product: Gum and metoclopramide

Gum-only

ACTIVE COMPARATOR

Chew one stick of sugar free gum (to be chewed over 15minutes) 8 hourly till either first flatus or feces was passed

Other: Gum

Metoclopramide-only

ACTIVE COMPARATOR

Intravenous metoclopramide 10mg 8hourly for the first 72hours post-operatively

Drug: Metoclopramide 10mg

Control

PLACEBO COMPARATOR

10ml of sterile water intravenously 8hourly for the first 72hours post-operatively

Other: Control

Interventions

Metoclopramide 10mg DRUG

Intravenous metoclopramide 10mg 8hourly for the first 72hours post-operatively

Also known as: Philometro, Hubei Tianyao

Metoclopramide-only

Gum and metoclopramide COMBINATION_PRODUCT

Intravenous metoclopramide 10mg 8hourly for the first 72hours post-operatively and one stick of sugar-free gum (over 15minutes) 8 hourly till either the first flatus or feces was passed

Gum-Metoclopramide

Gum OTHER

One stick of sugar-free gum (over 15minutes) 8 hourly till either the first flatus or feces was passed

Gum-only

Control OTHER

10ml of sterile water intravenously 8hourly for the first 72hours post-operatively

Control

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients requiring elective abdominal surgery aged 16-65years

You may not qualify if:

• Abdominal emergency surgeries
• Structural or functional inability to chew gum

Sponsors & Collaborators

• Ikechukwu Bartholomew Ulasi: lead

Study Sites (1)

University College Hospital

Ibadan, Oyo State, +234, Nigeria

Location

Related Publications (3)

• Pedziwiatr M, Kisialeuski M, Wierdak M, Stanek M, Natkaniec M, Matlok M, Major P, Malczak P, Budzynski A. Early implementation of Enhanced Recovery After Surgery (ERAS(R)) protocol - Compliance improves outcomes: A prospective cohort study. Int J Surg. 2015 Sep;21:75-81. doi: 10.1016/j.ijsu.2015.06.087. Epub 2015 Jul 29.

  PMID: 26231994 BACKGROUND

• COHEN J. The statistical power of abnormal-social psychological research: a review. J Abnorm Soc Psychol. 1962 Sep;65:145-53. doi: 10.1037/h0045186. No abstract available.

  PMID: 13880271 BACKGROUND

• Delaney C, Kehlet H, Senagore AJ, Bauer AJ, Beart R, Billingham R, et al. Postoperative ileus: profiles, risk factors, and definitions - a framework for optimizing surgical outcomes in patients undergoing major abdominal colorectal surgery. In: Bosker G, editor. Clinical consensus update in general surgery; 2006 May 1; Massachusetts United States. Roswell (GA): Pharmatecture, LLC; 2006. p. 1-26.

  BACKGROUND

MeSH Terms

Interventions

Metoclopramide; Chewing Gum

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ikechukwu B. Ulasi

  University College Hospital, Ibadan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Patients were randomized into a gum-metoclopramide (GM) group, a gum-only (G) group, a metoclopramide-only (M) group and a control (C) group. Patients in the GM group chewed gum and received intravenous metoclopramide, each 8 hourly. In the G group, patients chewed only gum while those in the M group received 10mg of intravenous metoclopramide only. To the C group, 10ml of intravenous sterile water for injection was given 8 hourly

Study Record Dates

• First Submitted: December 17, 2022
• First Posted: January 3, 2023
• Study Start: October 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: January 3, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)