Unilateral versus bilateral internal sphincterotomy: a randomised controlled trial for chronic fissure-in-ano

ISRCTN	ISRCTN60893979
DOI	https://doi.org/10.1186/ISRCTN60893979
Protocol serial number	N/A
Sponsor	Command Hospital Air Force Bangalore (CHAFB) (India)
Funder	Investigator initiated and funded (India)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Aswini Pujahari
Scientific

PG Department of Surgery
Command Hospital Air Force Bangalore (CHAFB)
Bangalore
560007
India

Primary study design	Interventional
Study design	Randomised, active controlled trial. Randomisation performed by sealed envelope method.
Secondary study design	Randomised controlled trial
Scientific title	Unilateral versus bilateral internal sphincterotomy: a randomised controlled trial for chronic fissure-in-ano
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Post-operative pain 2. Recurrences
Key secondary outcome measure(s)	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
Completion date	31/08/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	200
Total final enrolment	211
Key inclusion criteria	1. Disease over one year 2. Aged more than 18 years
Key exclusion criteria	1. Oral medication with nitrates, calcium channel blocker 2. Past ano-rectal surgery 3. Elderly lady with old perineal tear
Date of first enrolment	01/01/2004
Date of final enrolment	31/08/2006

PG Department of Surgery

Bangalore
560007
India

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/01/2010	06/08/2021	Yes	No

06/08/2021: Publication reference and total final enrolment added.