Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Alternative or research hypothesis:
The established surgery has a recurrence rate and there is chance of anal incontinence. There is no surgery which can be considered ideal. This new surgical intervention is likely to give better results then the established procedure.
Ethics approval
Ethics approval received from the Medical Research Committee of the Armed Forces Medical College (AFMC), Pune, India on the 26th December 2003 (ref: 2248/AFMRC/EC).
Study design
Randomised, active controlled trial. Randomisation performed by sealed envelope method.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chronic fissure-in-ano
Intervention
Group A (active control): single internal lateral sphinterotomy
Group B: (new treatment): double internal lateral sphinterotomy
A minimum follow up of 6 months.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Post-operative pain
2. Recurrences
Secondary outcome measures
1. Healing of fissure, measured at 3 to 6 months
2. Incontinence to flatuous and faecal matter, measured from the date of surgery until 6 months in the form of use of pad, soiling of undergarment
Overall trial start date
01/01/2004
Overall trial end date
31/08/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Disease over one year
2. Aged more than 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Over 100 on each arm, total more than 200
Participant exclusion criteria
1. Oral medication with nitrates, calcium channel blocker
2. Past ano-rectal surgery
3. Elderly lady with old perineal tear
Recruitment start date
01/01/2004
Recruitment end date
31/08/2006
Locations
Countries of recruitment
India
Trial participating centre
PG Department of Surgery
Bangalore
560007
India
Funders
Funder type
Other
Funder name
Investigator initiated and funded (India)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary