To compare the treatment efficacy of medical therapy using glyceryl trinitrate versus surgical lateral sphincterotomy in patients with chronic anal fissure
The study was carried out at CMH Peshawar, the population under study were patients with chronic anal fissure requiring treatment, since the procedural limitation did not allow patients blinding, the surgical specialists conducting the surgical procedure and the resident surgeon advising and applying the medical treatment (glyceryl trinitrate) were blinded to the study protocol using proformas marked X and Y for endorsing study outcomes in both groups respectively. The final analysis was carried out by an independent team unaware of the treatment modality given in patients and only outcomes variables were given to them for analysis
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients more than 18 years of age; with a chronic non-healing anal fissure more than 8 weeks duration; presenting to the surgical out-patient department for treatment.
Exclusion criteria: pregnancy, non-compliant to follow-up, history of recurrent anal fissures; surgical or medical intervention in the last 6 months; patients with major cardiac or respiratory disease; patients unwilling to be included in the study.
Intervention groups
Intervention Group 1: Group S (n=120) to receive surgical lateral sphincterotomy.
Lateral sphincterotomy was done by dissecting part of the internal anal sphincter to relieve fissure induced spasm.
Intervention Group 2: Group M (n=95) to receive glyceryl trinitrate. glyceryl trinitrate 0.2% (1-2ml) was used as local applicant not the fissure area to relieve spasm
Main outcome variables
Mean time for complete healing of the fissure, frequency of ulcer healing; median pain scores as assessed on the NRS (numerical rating scale); frequency of bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231201060234N1
Registration date:2024-06-22, 1403/04/02
Registration timing:retrospective
Last update:2024-06-22, 1403/04/02
Update count:0
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Rashid Ali
Name of organization / entity
Bolan medical college quetta
Country
Pakistan
Phone
+92 81 2850639
Email address
rashid_zahidbaloch@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-01, 1401/10/11
Expected recruitment end date
2023-06-30, 1402/04/09
Actual recruitment start date
2023-01-01, 1401/10/11
Actual recruitment end date
2023-06-30, 1402/04/09
Trial completion date
empty
Scientific title
Comparison between treatment efficacy of glyceryl trinitrate and lateral sphincterotomy for chronic anal fissure
Public title
Medical versus surgical treatment for chronic anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients more than 18 years of age
With a chronic non-healing anal fissure more than 8 weeks duration
Presenting to the surgical out-patient department for treatment.
Exclusion criteria:
Pregnancy
Recurrent anal fissures
Major cardiac or respiratory disease
Unwilling to be included in the study
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
240
Actual sample size reached:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was done using individual type. The method used was chits marked X and Y using the lottery method. The sealed chits were selected once the patient entered the recovery room. The resident surgeon deputed for patient selection of the chits was unaware of the study protocol and allocation concealment was done. Only the consultant in the operating room was aware of the protocol.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the final assessor and data analyzer were unaware of the study protocol
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Review board CMH Peshawar
Street address
Mall road; Peshawar
City
Peshawar
Postal code
25000
Approval date
2023-02-07, 1401/11/18
Ethics committee reference number
CMH- PSC-0056
Health conditions studied
1
Description of health condition studied
Chronic anal fissure
ICD-10 code
K60.1
ICD-10 code description
Chronic anal fissure
Primary outcomes
1
Description
Mean time to complete fissure healing
Timepoint
Assessed weekly after intervention till endpoint of healing or failure of healing after 8 weeks
Intervention group 1: Surgical lateral sphincterotomy group. Patients in Group S received the surgical procedure by a consultant surgeon and part of the internal anal sphincter was dissected to relieve the fissure induced spasm and were followed up till 8 weeks at 4,6 and 8 week duration for the primary and secondary outcomes mentioned.
Category
Treatment - Surgery
2
Description
Intervention group 2: Glyceryl trinitrate group.Patients received 0.2% ointment of glyceryl trinitrate and directed by a resident surgeon on its correct application in the perianal area using 1-2 ml twice a day for a total of 8 weeks and followed up similarly at 4,6 and 8 weeks duration.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
CMH Peshawar
Full name of responsible person
Dr. Rashid
Street address
CMH Road
City
Peshawar
Postal code
25000
Phone
+92 333 3384051
Email
rashid_zahidbaloch@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
CMH Peshawar
Full name of responsible person
Dr Rashid Baloch
Street address
CMH Road
City
Peshawar
Postal code
25000
Phone
+92 333 3384051
Email
rashid_zahidbaloch@hotmail.com
Grant name
None
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CMH Peshawar
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
CMH Peshawar
Full name of responsible person
Rashid Ali
Position
PG Gen surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
D7
City
Peshawar
Province
KPK
Postal code
25000
Phone
+92 81 2850639
Fax
Email
Rashid_zahidbaloch@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
CMH Peshawar
Full name of responsible person
Rashid Ali
Position
PG Gen surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
D7
City
Peshawar
Province
KPK
Postal code
25000
Phone
+92 81 2850639
Fax
Email
Rashid_zahidbaloch@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
CMH Peshawar
Full name of responsible person
Rashid Ali
Position
PG Gen surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
D7
City
Peshawar
Province
KPK
Postal code
25000
Phone
+92 81 2850639
Fax
Email
Rashid_zahidbaloch@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the data including patients records (excluding patient identification IDs), excel sheets, analysis proformas and SPSS output sheets will be made available to all researchers for academic purposes when requested through online repository, link of which will be shared once approval given from the primary author and the institute in which the study was carried out
When the data will become available and for how long
Will be available indefinitely pending approval by the primary author and institute
To whom data/document is available
For academic purposes only
Under which criteria data/document could be used
The manuscript along with SPSS data sets and output sheets will be shared once published by the journal
Will be shared via email
From where data/document is obtainable
Will be sent both my email and will be available online and link would be provided as well on Google Drive
What processes are involved for a request to access data/document