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.: PACTR201807152935140 Date of Approval: 12/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pile Infrared-photocoagulation versus Ligation Exploratory Study Programme
Official scientific title Infrared photocoagulation versus rubber band ligation of first, second and third degree haemorrhoids in Jos University Teaching Hospital.
Brief summary describing the background and objectives of the trial Background In the climate of cost containment, competition for patients, improved patient education and rise in malpractice suits, an unambiguous trend is developing away from surgical haemorrhoidectomy and towards office treatment of haemorrhoids globally. Two meta-analyses have shown that rubber band ligation and infrared photocoagulation are treatments of choice for first to third degree haemorrhoids. However, the superiority of one modality over the other is not a matter of consensus, and there is no identified local study that has answered this question. In Africa¿s low resource settings, we must carefully decide by evidence-based processes which of these options to selectively invest in and advance as first-line. Objectives The study¿s general objective is to compare the effectiveness of infrared photocoagulation and rubber band ligation in the treatment of symptomatic Grade I, II and III internal haemorrhoids. The specific objectives are to determine the effectiveness (success rate) of both procedures in the resolution of Grade I, II and III haemorrhoidal pathology, to compare the incidence of early complications (post-procedure pain, rectal tenesmus, bleeding, anal discharge) and to determine the time to resumption of normal daily activities following both procedures.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) P.I.L.E.S.
Disease(s) or condition(s) being studied Digestive System,Haemorrhoids,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 10/06/2018
Actual trial start date
Anticipated date of last follow up 31/12/2018
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
EXM/PR/SURG/VOL.16/083 West African College of Surgeons
JUTH/DCS/ADM/127/XXVII/165 Jos University Teaching Hospital Institutional Health Research Ethics Committee
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 from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Rubber band ligation once not applicable Using a Barron's ligator through an anoscope, 2 rubber bands are applied to the insensate base of each symptomatic haemmorrhoid after grasping it with an Allis forceps while patients is in left lateral position. 29 Active-Treatment of Control Group
Experimental Group Infrared Photocoagulation once not applicable Through a proctoscope, the tip of a Lumatec IRK 151 Infrared coagulator probe with light pulse timer set to 1.25 seconds is applied to the base of the visualised haemorrhoid high above the dentate line and its applicator compressed. A second coagulation is made on moving the probe in a clockwise direction and directing the beam approximately at a 90¿ angle to the first. 29
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adult patients with symptomatic Goligher grade I haemorrhoids (which do not prolapse) requiring treatment. 2. Adult patients with symptomatic Goligher grade II haemorrhoids (which prolapse during defaecation and reduce spontaneously) requiring treatment 3. Adult patients with symptomatic Goligher grade III haemorrhoids (which prolapse during defaecation and need to be manually reduced) requiring treatment. 1. Patients presenting with Goligher Grade IV haemorrhoids, thrombosed haemorrhoids or infected haemorrhoids. 2. Patients with haemorrhoids associated with malignancy, inflammatory bowel disease or pregnancy. 3. Patients with associated anal fissures, anal spasm or infective anal pathologies like cryptitis or proctitis. 4. Patients with coagulation disorders as determined by clinical or laboratory parameters. 5. History of uncontrolled diabetes mellitus or other immunosuppressive illness. 6. Uncontrolled hypertension and other co-morbidities. 7. Patients who request for a particular modality of office treatment or surgery. 8. Patients who have had previous treatments beyond conservative measures including minimally invasive haemorrhoid treatments or haemorrhoidectomy. 9. Patients on oral flavinoid compounds or those applying micronised purified flavinoid derivatives locally to the anal region. 18 Year(s) 100 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 24/05/2017 Jos University Teaching Hospital Institutional Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Jos University Teaching Hospital, Lamingo Jos 930232 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The resolution of all presenting symptoms and anatomical obliteration of the haemorrhoids. 4 weeks
Secondary Outcome The time to resumption of duties Recorded in days (whenever patient returns to regular activity)
Secondary Outcome Post procedure pain 0 minutes (immediate post procedure) 30 minutes post procedure 6 hours post procedure 24 hours post procedure 72 hours post procedure
Secondary Outcome early complication- bleeding 1 week post procedure 2 weeks post procedure 4 weeks post procedure
Secondary Outcome early complication-anal discharge 1 week post procedure 2 weeks post procedure 4 weeks post porocedure
Secondary Outcome early complication- rectal tenesmus 1 week post procedure 2 weeks post procedure 4 weeks post procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jos University Teaching Hospital, Surgery Out Patient Department Lamingo Jos 930232 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Prof. MA.Misauno Department of Surgery, Jos University Teaching Hospital, Lamingo Jos 930232 Nigeria
Dr BO Ismaila Department of Surgery, Jos University Teaching Hospital Jos 930232 Nigeria
Dr Barnabas Alayande Department of Surgery, Jos University Teaching Hospital Jos 930232 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Barnabas Alayande Department of Surgery, Jos University Teaching Hospital Jos 930232 Nigeria Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Dr Barnabas Alayande Department of Surgery, Jos University Teaching Hospital Jos 930232 Nigeria
Prof. MA.Misauno Department of Surgery, Jos University Teaching Hospital Jos 930232 Nigeria
Dr BO Ismaila Department of Surgery, Jos University Teaching Hospital Jos 930232 Nigeria
Dr EO Ojo Department of Surgery, Jos University Teaching Hospital Jos 930232 Nigeria
Dr Ale Femi Department of Surgery, Jos University Teaching Hospital Jos 930232 Nigeria
Dr Mercy Isichei Department of Surgery, Jos University Teaching Hospital Jos 930232 Nigeria
Prof AZ Sule Department of Surgery, Jos University Teaching Hospital Jos 930232 Nigeria
Dr IO Omofuma Department of Surgery, Jos University Teaching Hospital Jos 930232 Nigeria
Dr J Okoko Department of Surgery, Jos University Teaching Hospital Jos 930232 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Barnabas Alayande dr.alayande@gmail.com 08035819290 Department of Surgery, Jos University Teaching Hospital
City Postal code Country Position/Affiliation
Jos 930232 Nigeria Senior Registrar / Jos University Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Barnabas Alayande dr.alayande@gmail.com 08035819290 Department of Surgery, Jos University Teaching Hospital
City Postal code Country Position/Affiliation
Jos 930232 Nigeria Senior Registrar / Jos University Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Barnabas Alayande dr.alayande@gmail.com 08035819290 Department of Surgery, Jos University Teaching Hospital
City Postal code Country Position/Affiliation
Jos 930232 Nigeria Senior Registrar / Jos University Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Proforma Informed Consent Form,Study Protocol July 2019, 1 year Access criteria is controlled. IPD metaanalysis willbe allowed. Process is initiated via request data/documents by email to barnabasalayande@yahoomail.com. Decisions granting access will be determined by Professor Augustine Sule, Endocrine Surgery Consultant/ Chair, Jos University Teaching Hospital and the sitting Head of Department, General Surgery, Jos University Teaching Hospital. Criteria for reviewing requests will include qualifications and quality of request.
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