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.: PACTR202110667430356 Date of Approval: 08/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Milligan Morgan hemorrhoidectomy under local anesthesia versus saddle block: A randomized controlled trial
Official scientific title Open hemorrhoidectomy under local anesthesia versus saddle block at Kampala International University Teaching Hospital: A randomized controlled trial
Brief summary describing the background and objectives of the trial Hemorrhoids, the most prevalent anal disease, is defined as collections of submucosal, fibrovascular, arterio-venous sinusoids that are part of the anorectum. Many surgeons currently use various management options to treat hemorrhoids. These options range from conservative treatment including dietary measures and sclerotherapy to surgical techniques include band ligation and excision based on the degree of prolapse and the classification by Banov and colleagues, grade III and IV hemorrhoids are amenable to surgical treatment and open hemorrhoidectomy seems to be the most common technique widely effective for grade III and IV hemorrhoids. While open hemorrhoidectomy under local anesthesia is well applied in developed countries, it is not the case in low-income countries like Uganda, which would actually benefit most from this technique. Purpose of the study This study aims to compare open hemorrhoidectomy using local anesthesia versus saddle block among patients with primary uncomplicated 3rd or 4th-degree hemorrhoids at KIU-TH in Uganda. Specific objectives i. To assess the occurrence of postoperative pain following open hemorrhoidectomy under local anesthesia versus open hemorrhoidectomy under saddle block; ii. To compare the mean operative time for open hemorrhoidectomy under local anesthesia versus open hemorrhoidectomy under saddle block; iii. To compare the cost-effectiveness between open hemorrhoidectomy under local anesthesia and Saddle block.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/11/2021
Actual trial start date
Anticipated date of last follow up 28/02/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 58
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Dynamic (adaptive) random allocation such as minimization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A - 7 days Open hemorrhoidectomy under local anesthesia 29
Control Group Group B - 7 days Open hemorrhoidectomy under saddle block 29 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients aged between 18-65 years Uncomplicated 3rd or 4th degree hemorrhoids Classify by American Society of Anesthesiologists (ASA) as I and II Documented contraindication of spinal anesthesia such as chronic backache and spinal deformities, previous perianal surgery, known history of allergy to the drugs used in the study, Bleeding disorders 3rd or 4th degree thrombosed hemorrhoids, Active inflammatory bowel disease, Pregnancy, Documented neoplasm situated distal aspect of the large bowel or rectum, Liver diseases with portal hypertension Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),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 02/06/2021 KAMPALA INTERNATIONAL UNIVERSITY WESTERN CAMPUS RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
Bassajja ishaka 070 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Occurrence of pain following open hemorrhoidectomy will be determined in both groups using the Visual analogue Scale (VAS) 2,4, 6 hours and 7 days
Secondary Outcome Mean operative time of open hemorrhoidectomy in both groups Start up to end of surgical procedure including anesthesia time
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
kampala international university teaching hospital Bassajja Ishaka 070 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Franck Katembo Sikakulya Bassaja Ishaka Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Katembo Sikakulya Bassaja Ishaka Uganda Individual
COLLABORATORS
Name Street address City Postal code Country
okedi Francis Xaviour Bassaja Ishaka Uganda
Robinson Ssebuufu Bassaja Ishaka Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Franck Sikakulya francksikakulya@gmail.com +256752513599 Bassaja
City Postal code Country Position/Affiliation
Ishaka 071 Uganda Resident
Role Name Email Phone Street address
Public Enquiries Okedi Francis Xaviour okedifrancisxaviour@gmail.com +256772196223 Bassaja
City Postal code Country Position/Affiliation
Ishaka 071 Uganda Supervisor
Role Name Email Phone Street address
Scientific Enquiries Robinson Ssebuufu rssebuufu@gmail.com +257772507248 Bassaja
City Postal code Country Position/Affiliation
Ishaka 071 Uganda Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data will be available Informed Consent Form,Statistical Analysis Plan,Study Protocol One year after the study University archives
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