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

Sponsor

Ikechukwu Bartholomew Ulasi (Other)

Overall Status

Completed

CT.gov ID

NCT05669781

Collaborator

(none)

105

Enrollment

Location

Arms

Actual Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ileus Postoperative	Drug: Metoclopramide 10mg Combination Product: Gum and metoclopramide Other: Gum Other: Control	Phase 4

Detailed Description

This was a prospective randomized controlled trial that recruited all patients requiring elective abdominal surgery, aged 16-65years. Abdominal emergency surgeries and structural or functional inability to chew gum constituted the exclusion criteria. A written informed consent was obtained from all eligible patients.

Considering an effect size of 0.8(Cohen, 1962)2 at a power of 80% with 95% level of confidence and type-1 error of 5%, a total sample size of 105 study participants was obtained, having considered an attrition rate of 5%. Study participants were randomized into 4 groups (a gum-metoclopramide group, a gum-only group, a metoclopramide-only group and a control group) using blocked sequence randomization.

Data was obtained through a detailed history and physical examination and include demographic variables like age and gender. Medical history of previous abdominal surgeries and any comorbidity like chronic constipation, diabetes mellitus, parkinsonism, renal or cardiac disease were sought and allergy to metoclopramide or gum noted. Body Mass Index (BMI) and relevant investigation results were recorded. Other pre- and intra-operative data recorded included: clinical diagnosis, American Society of Anaesthesiologists (ASA) grade, type of anaesthesia, cadre of surgeon, surgical access (laparoscopic versus open), length of skin incision, intra-operative blood loss, total intra-operative fluid administered, duration of surgery, surgical procedure done and duration of anaesthesia. Recorded post-operatively were time to passage of first flatus, time to passage of first feces, time to initial recording of bowel sounds, time to tolerance of normal diet, day of first ambulation, length of hospital stay, cost of hospital stay and post-operative complications.

Informed consent was obtained from all patients that met the inclusion criteria. All patients for elective surgery were admitted at least a day prior to surgery and kept on nothing by mouth from 12midnight on the eve of surgery. Patients were given intravenous metronidazole and ceftriaxone at the induction of anaesthesia. All the patients had general anaesthesia. Abdominal skin incision was made by the surgeon who was either a senior registrar or consultant in general surgery and to whom the patient's group was undisclosed. Standard procedures (surgical and anesthetic) relevant for each case were carried out. The group assigned to each patient was known only to the research assistants (a house surgeon and the nursing staff) who alone administered the intervention to the appropriate groups. Although what was used for intravenous intervention was undisclosed to the patients in the GM, M and C groups, it was not possible to blind patients who received gum only (G group).

All interventions were commenced from the 1st post-operative day. Patients in the gum-only(G) group were given one stick of sugar free gum (Orbit, Wrigley, US) 3 times 8 hourly daily (in the morning, afternoon and in the evening) till either first flatus or feces was passed with an instruction to chew for 15 minutes(only) without swallowing the chewed gum. The criteria for discontinuing each intervention was not disclosed to the patients. The gum was given to patients at a fixed interval to help monitor compliance. Patients in the metoclopramide-only (M) group received intravenous metoclopramide (Philometro, Hubei Tianyao) 10mg 8hourly for the first 72hours post-operatively. The gum-metoclopramide (GM) group received intravenous metoclopramide and also chewed gum using the protocol earlier described for gum only and metoclopramide only groups. Patients assigned to the control (C) group received 10ml of sterile water intravenously 8hourly for the first 72hours post-operatively.

All patients were asked to notify the nursing staff at first passage of flatus. A blinded doctor visited the patients 8hourly and recorded the time of the first bowel sounds, passage of flatus, and defecation. After giving each intervention, the type and time of intervention was documented in an identifier-free patient's questionnaire. The first time of flatus and defecation was recorded based on the patient's own statements. Prolonged post-operative ileus was defined as ileus lasting more than 5days following laparotomy or greater than 3days following laparoscopic surgery.3 Nasogastric tube was removed on the day of return of bowel function. The total duration of hospital stay, calculated from the first post-operative day to the day of discharge, was recorded.

The association between categorical and numerical peri-operative factors with prolonged post-operative ileus was analyzed using the Chi-square (and Fisher's exact) test and independent t-test (and Mann Whitney-U test) respectively. Comparison of groups in terms of the duration of post-operative ileus and duration of hospital stay was done using analysis of variance (ANOVA). Secondary endpoints compared between the groups included time to first bowel sound, duration of hospital stay and cost of hospital stay. Statistical significance was set at a p-value of <0.05. Version 23 of the Statistical Package for Social Sciences for Windows was used to analyze all data obtained from this study.

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

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 hourlyPatients 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

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

The Effects of Combined Gum-chewing and Parenteral Metoclopramide on the Duration of Post-operative Ileus After Abdominal Surgery

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Sep 30, 2019

Actual Study Completion Date :

Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Gum-Metoclopramide 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 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
Active Comparator: Gum-only Chew one stick of sugar free gum (to be chewed over 15minutes) 8 hourly till either first flatus or feces was passed	Other: Gum One stick of sugar-free gum (over 15minutes) 8 hourly till either the first flatus or feces was passed
Active Comparator: Metoclopramide-only Intravenous metoclopramide 10mg 8hourly for the first 72hours post-operatively	Drug: Metoclopramide 10mg Intravenous metoclopramide 10mg 8hourly for the first 72hours post-operatively Other Names: Philometro, Hubei Tianyao
Placebo Comparator: Control 10ml of sterile water intravenously 8hourly for the first 72hours post-operatively	Other: Control 10ml of sterile water intravenously 8hourly for the first 72hours post-operatively

Outcome Measures

Primary Outcome Measures

Duration of post-operative ileus [From 24 hours after surgery up to the time either flatus or feces is passed, for up to 1week after surgery]
Time to either the passage of flatus or feces, assessed every 8hours from post-operative day 1

Secondary Outcome Measures

Duration of hospital stay [First post-operative day up to the day of discharge, for up to 25days after surgery]
Length of in-hospital care after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients requiring elective abdominal surgery aged 16-65years

Exclusion Criteria:

Abdominal emergency surgeries
Structural or functional inability to chew gum

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University College Hospital	Ibadan	Oyo	Nigeria	+234

Sponsors and Collaborators

Ikechukwu Bartholomew Ulasi

Investigators

Principal Investigator: Ikechukwu B. Ulasi, University College Hospital, Ibadan

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Ikechukwu Bartholomew Ulasi, Principal investigator, University College Hospital, Ibadan

ClinicalTrials.gov Identifier:

NCT05669781

Other Study ID Numbers:

UI/EC/18/0231

First Posted:

Jan 3, 2023

Last Update Posted:

Jan 3, 2023

Last Verified:

Dec 1, 2022

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:

Keywords provided by Ikechukwu Bartholomew Ulasi, Principal investigator, University College Hospital, Ibadan

Additional relevant MeSH terms:

Ileus

Metoclopramide

Study Results

No Results Posted as of Jan 3, 2023