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

ISRCTN ISRCTN60893979
DOI https://doi.org/10.1186/ISRCTN60893979
Secondary identifying numbers N/A
Submission date
06/09/2007
Registration date
24/09/2007
Last edited
06/08/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Aswini Pujahari
Scientific

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

Study information

Study designRandomised, active controlled trial. Randomisation performed by sealed envelope method.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleUnilateral versus bilateral internal sphincterotomy: a randomised controlled trial for chronic fissure-in-ano
Study objectivesAlternative 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) studiedChronic fissure-in-ano
InterventionGroup A (active control): single internal lateral sphinterotomy
Group B: (new treatment): double internal lateral sphinterotomy

A minimum follow up of 6 months.
Intervention typeOther
Primary outcome measure1. Post-operative pain
2. Recurrences
Secondary outcome measures1. 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 study start date01/01/2004
Completion date31/08/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsOver 100 on each arm, total more than 200
Total final enrolment211
Key inclusion criteria1. Disease over one year
2. Aged more than 18 years
Key exclusion criteria1. Oral medication with nitrates, calcium channel blocker
2. Past ano-rectal surgery
3. Elderly lady with old perineal tear
Date of first enrolment01/01/2004
Date of final enrolment31/08/2006

Locations

Countries of recruitment

  • India

Study participating centre

PG Department of Surgery
Bangalore
560007
India

Sponsor information

Command Hospital Air Force Bangalore (CHAFB) (India)
Hospital/treatment centre

c/o Dr A.K. Pujahari
PG Department of Surgery
Air Force
Bangalore
560007
India

ROR logo "ROR" https://ror.org/05cx69s52

Funders

Funder type

Other

Investigator initiated and funded (India)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

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