Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202206468032528 Date of Approval: 01/06/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Chewing Gum on Duration of Postoperative Ileus Following Laparotomy for Gastroduodenal Perforations; a Multi Centre RCT.
Official scientific title Effect of Chewing Gum on Duration of Postoperative Ileus Following Laparotomy for Gastroduodenal Perforations; a Multi Centre RCT.
Brief summary describing the background and objectives of the trial Background Prolonged post-operative ileus is associated with increased risk of other complications, length of hospital stays and health care related costs. Chewing gum has been shown to reduce duration of ileus in many elective surgeries, but there is a paucity of randomised controlled trials (RCTs) on its effect on duration of ileus among patients undergoing emergency surgery, specifically patients with peritonitis. The aim of this study is to determine the effect of chewing gum on duration of postoperative ileus following laparotomy for gastroduodenal perforations. Methods This will be a randomised controlled trial done in 3 hospitals. Fifty-two patients will be randomised to 2 groups. Group A will receive chewing gum in addition to routine care, whereas group B will receive routine care only. The duration of post-operative ileus in the two groups which is the primary outcome, will be compared using the independent samples t-test in SPSS version 22. The length of hospital stay, in-hospital morbidity and mortality will be the secondary outcomes. This trial has been approved by Kampala International University research and Ethics committee (Ref No. KIU-2021-60) and Uganda national council of science and technology (Ref No. HS1665ES). Retrospective registration with the research registry has also been done (UIN: researchregistry8565).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Chewing
Disease(s) or condition(s) being studied Digestive System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/04/2022
Actual trial start date 01/04/2022
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date 30/09/2022
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 52
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Routine care No chewing gum was given the routine care was done in both groups Routine care as shown in the description Routine care as shown in description IV Normal saline and 5% dextrose in the ratio of 2:1, which was prescribed for the first 24 hours with the total volume determined by the 4:2:1 rule for calculating maintenance fluids. The fluid prescriptions that followed, was according to fluid balance chart. Other post-operative instructions included; IV ceftriaxone 2g once a day (OD) for 5 days, IV metronidazole 500mg 8 hourly for 5 days, IV Omeprazole 40mg OD till oral feeding is initiated, IV Paracetamol 1g 8 hourly till oral feeding was initiated, Oral sips with water were started on first POD, NGT was removed after 48 hours, ambulation was encouraged from first Post operative day (POD) 26 Uncontrolled
Experimental Group Chewing Gum Plus Routine care two pellets (2.8g) chewed till they are tasteless three times daily till patient passed stool or flatus Green PK brand of chewing gum was used in this study since a pilot survey done before data collection showed that majority of the people preferred the green flavor and we wanted to use one flavor to minimize bias. The patients in Group A were given green flavored PK and started chewing after regaining consciousness. Any patient unable to start chewing within 24 hours was excluded from the study. The patients chewed 2 pellets of PK till they were tasteless three times in a day (morning, afternoon and evening). After chewing, the patients were encouraged to rinse the mouth with clean water. The patients stopped chewing gum when POI resolved which was defined as passage of stool or flatus or both. The routine care Included IV Normal saline and 5% dextrose in the ratio of 2:1, which was prescribed for the first 24 hours with the total volume determined by the 4:2:1 rule for calculating maintenance fluids. The fluid prescriptions that followed, was according to fluid balance chart. Other post-operative instructions included; IV ceftriaxone 2g once a day (OD) for 5 days, IV metronidazole 500mg 8 hourly for 5 days, IV Omeprazole 40mg OD till oral feeding is initiated, IV Paracetamol 1g 8 hourly till oral feeding was initiated, Oral sips with water were started on first (post operative day (POD), NGT was removed after 48 hours, ambulation was encouraged from first POD 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients with confirmed gastric or duodenal perforation, between the age of 18 and 65 will be included. The upper age limit will be used because increasing age increases the risk of PPOI [10] yet we want the groups to be comparable. i. patients with documented allergies to the contents of chewing gum ii. Patients with uncontrolled diabetes mellitus disease at the time of surgery since we are using a sugared type of chewing gum that may worsen the glycemic status. iii. Patients who will be unconscious or unable to chew gum after 24 hours post-surgery iv. Patients with traumatic perforations will be excluded. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/01/2022 Kampala international university research ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ishaka- Bushenyi-Uganda Ishaka PO Box 71 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Duration of post operative ileus when patient passed flatus or passed stool or both following surgery for gastroduodenal perforation
Secondary Outcome Length of hospital stay when patient was discharged from hospital following operation
Secondary Outcome mortality and morbidity post operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kampala International University Ishaka-bushenyi- Uganda Ishaka Uganda
Hoima regional referral Hospital Hoima-Uganda Hoima Uganda
Fort portal Regional referral Hospital Fort portal- uganda Fort portal Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Muhumuza Joshua Ishaka Bushenyi Ishaka Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self Ishaka-Bushenyi Ishaka Uganda Individual
COLLABORATORS
Name Street address City Postal code Country
Lule Harman Ishaka bushenyi Ishaka Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joshua Muhumuza joshuablessed7@gmail.com +256779223560 Ishaka-bushenyi
City Postal code Country Position/Affiliation
Ishaka Uganda Teaching Assistant Kampala international University
Role Name Email Phone Street address
Public Enquiries Joshua Muhumuza joshuablessed7@gmail.com +256779223560 Ishaka-Bushenyi
City Postal code Country Position/Affiliation
Ishaka Uganda Teaching assistant Kampala International University
Role Name Email Phone Street address
Scientific Enquiries Joshua Muhumuza joshuablessed7@gmail.com +256779223560 Ishaka-Bushenyi
City Postal code Country Position/Affiliation
Ishaka Uganda Teaching assistant Kampala International university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data be available (including data dictionaries) All of the individual participant data collected during the trial, after deidentification will be shared The other documents shared will include Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report, Analytic Code Data will be made available Immediately following publication, No end date to Anyone who wishes to access the data for Any purpose Proposal should be directed to joshuablessed7@gmail.com. To gain access, data requestors will need to sign a data access agreement. Data are available at a third party website (https://drive.google.com/drive/folders/19-PNinLto5UY44WbD2B5y4sXkofqv9dH) Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months from completion Individual participant data be available (including data dictionaries) All of the individual participant data collected during the trial, after deidentification will be shared The other documents shared will include Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report, Analytic Code Data will be made available Immediately following publication, No end date to Anyone who wishes to access the data for Any purpose Proposal should be directed to joshuablessed7@gmail.com. To gain access, data requestors will need to sign a data access agreement. Data are available at a third party website shown in the bracket (https://drive.google.com/drive/folders/19-PNinLto5UY44WbD2B5y4sXkofqv9dH)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://drive.google.com/drive/folders/19-PNinLto5UY44WbD2B5y4sXkofqv9dH No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information