Unilateral versus bilateral internal sphincterotomy: a randomised controlled trial for chronic fissure-in-ano
ISRCTN | ISRCTN60893979 |
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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
Scientific
PG Department of Surgery
Command Hospital Air Force Bangalore (CHAFB)
Bangalore
560007
India
Study information
Study design | Randomised, active controlled trial. Randomisation performed by sealed envelope method. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 01/01/2004 |
Completion date | 31/08/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Over 100 on each arm, total more than 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 |
Locations
Countries of recruitment
- India
Study participating centre
PG Department of Surgery
Bangalore
560007
India
560007
India
Sponsor information
Command Hospital Air Force Bangalore (CHAFB) (India)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr A.K. Pujahari
PG Department of Surgery
Air Force
Bangalore
560007
India
https://ror.org/05cx69s52 |
Funders
Funder type
Other
Investigator initiated and funded (India)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | 01/01/2010 | 06/08/2021 | Yes | No |
Editorial Notes
06/08/2021: Publication reference and total final enrolment added.