Condition category
Digestive System
Date applied
06/09/2007
Date assigned
24/09/2007
Last edited
24/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Aswini Pujahari

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Command Hospital Air Force Bangalore (CHAFB) (India)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes