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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202011687956222 Date of Registration: 18/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of shea butter and lidocaine gel for rectal examination: A non-inferiority trial
Official scientific title Comparison of shea butter and lidocaine gel for rectal examination: A non-inferiority trial
Brief summary describing the background and objectives of the trial Digital rectal examination is a physical examination tool used by doctors to assess several medical conditions. The procedure involves the use of a lubricant to ease the passage of the examining finger into the rectum. Several lubricants have been used including 2% lidocaine gel, K-Y gel and surgilube. The prohibitive cost of these lubricants have resulted in a situation of limited availability. Shea butter on the other hand is a cheaper option, readily available in our sub-region, and above all has lubricating properties and may be an effective replacement for the known lubricants. In this study, we compare the effectiveness of shea butter to lidocaine gel as a lubricant for digital rectal examination. General objective: To compare the effectiveness, complications and ease of use of shea butter to lidocaine gel as a surgical lubricant for digital rectal examination.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/01/2021
Actual trial start date 15/06/2021
Anticipated date of last follow up 03/10/2022
Actual Last follow-up date 31/10/2022
Anticipated target sample size (number of participants) 152
Actual target sample size (number of participants) 153
Recruitment status Closed to recruitment,follow-up continuing
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 Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group shea lubricant group Adequate quantity of gel for each rectal examination Rectal examination time will range between 1 minute and 5 minutes Male and female patients, 18 years and above who presents to the Accident and Emergency unit and the surgical unit for whom a digital rectal examination is indicated, meets our eligibility criteria and willing to participate in the study would be recruited. A computerized random number generator would be employed to allocate patients to the two groups (Shea butter and lidocaine gel). Patients assigned an odd number, will belong to Group 1(Shea butter group) while those with even numbers will belong to Group 2 (lidocaine gel group). The process will continue till the required sample number is obtained in each group. The examination procedure will be explained to all patients and an informed consent sought before it is performed. The patient is then placed in the left lateral position with the knees flexed and extended towards the chest. Adequate quantity of the shea lubricant is then applied to the examining finger (index finger), the anal opening parted and the finger gently introduced into the rectum to examine the prostate (in males) and the rectum, checking for mobility of the rectal mucosa, palpable masses, the presence or absence of strictures and tenderness. Questionnaires would be administered to patients before the procedure, immediately after the procedure and 30 minutes afterwards to assess pain perception, discomfort, peri-anal pruritus, urinary and bowel urgency. 75
Control Group Lidocaine gel group Adequate quantity of gel for rectal examination Rectal examination time will range from 1 to 5 minutes Patients assigned an odd number, will belong to Group 1(Shea butter group) while those with even numbers will belong to Group 2 (lidocaine gel group). The process will continue till the required sample number is obtained in each group. The examination procedure will be explained to all patients and an informed consent sought before it is performed. The patient is then placed in the left lateral position with knee flexed and extended towards the chest. Adequate amount of the lubricating gel is then applied to the examining finger (index finger), the anal opening parted and the examining finger gently introduced into the rectum. The rectal examination time will range between 1 and 5 minutes. Questionnaires would be administered to patients before the procedure, immediately after the procedure and 30 minutes afterwards to assess pain perception, discomfort, peri-anal pruritus, urinary and bowel urgency. 78 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All male and female patients, conscious, 18 years and above a digital rectal examination is indicated and consents to partake in the study Patients who are too ill to communicate and consent painful anal conditions (anal fissures, thrombosed hemorrhoids, infiltrating anorectal cancers) rectal stricture Patients unwilling to participate. 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 19/08/2020 University of Health and Allied Sciences research and ethics committee
Ethics Committee Address
Street address City Postal code Country
Sokode Titrinu Ho 0031 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the primary end point is difference in pain perception before, immediately and 30 minutes after procedure, with a non-inferiority limit set at - 0.72. immediately before and after examination procedure and 30 minutes afterwards
Secondary Outcome differences in complication rates including discomfort, urinary urgency, bowel urgency and perianal pruritus. The convenience or otherwise associated with the use of the lubricant will also be assessed. Immediately before and after the procedure and 30 minutes afterwards
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ho Teaching Hospital Off Denu - Ho road Ho PMB 31 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Heath and Allied Sciences Sokode Titrinu Ho PMB 31 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Health and Allied Sciences Research fund sokode titrinu Ho PMB 31 Ghana University
COLLABORATORS
Name Street address City Postal code Country
Dr Kokou Amegan Aho Sokode, Ho HO 0031 Ghana
Dr. Davidson Iroko Mawuli estate Ho 00752 Ghana
Dr Orish Verner Ndudiri Trafalgar Ho 0031 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kekeli Adanu kkadanu@uhas.edu.gh +233506816784 Voradep Village
City Postal code Country Position/Affiliation
Ho MA 315 Ghana Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries David Adedia dadedia@uhas.edu.gh +233244845294 voradep village
City Postal code Country Position/Affiliation
Ho PMB 31 Gibraltar Investigator
Role Name Email Phone Street address
Public Enquiries Davidson Iroko iroko.dok@gmail.com +233503838996 Mawuli estate
City Postal code Country Position/Affiliation
Ho PMB 31 Ghana Investigator and Public relations officer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All Individual participant data that will underlie the report from this study after deidentification (text, tables, figures, and appendices). Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Data will be available upon request and approval from the University of Health and Allied Sciences. Essential data will be made available on figshare 2 years after study completion
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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