| CTRI Number |
CTRI/2022/10/046651 [Registered on: 20/10/2022] Trial Registered Prospectively |
| Last Modified On: |
19/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Laternal Internal Sphincterotomy versus Manual Anal Dilatation in Chronic Anal Fissure |
|
Scientific Title of Study
|
Lateral Internal Sphincterotomy versus Manual Anal Dilatation in Chronic Anal Fissure- A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ponprabu |
| Designation |
Postgraduate |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Room no 227, Annex building, Pondicherry Institute of Medical Sciences, Kalapet
Pondicherry
PONDICHERRY
605014
India |
| Phone |
8220691685 |
| Fax |
|
| Email |
d.m.ponprabu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Peter Manoharan Chelappa |
| Designation |
Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of General Surgery,Pondicherry Institute of Medical Sciences, Kalapet
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9447591100 |
| Fax |
|
| Email |
peternirmala@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ponprabu |
| Designation |
Postgraduate |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of General Surgery,Pondicherry Institute of Medical Sciences, Kalapet
Pondicherry
PONDICHERRY
625009
India |
| Phone |
08220691685 |
| Fax |
|
| Email |
d.m.ponprabu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional support (PIMS) |
|
|
Primary Sponsor
|
| Name |
Pondicherry Institute of medical Sciences |
| Address |
Department of General Surgery
Pondicherry Institute of medical Sciences, Kalapet |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ponprabu |
Pondicherry Institute of medical Sciences |
Department of General Surgery
Pondicherry Institute of edical Sciences, Kalapet
Pondicherry
PONDICHERRY |
8220691685
d.m.ponprabu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K601||Chronic anal fissure, (2) ICD-10 Condition: K602||Anal fissure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lateral Internal Sphincterotomy |
49 patients will be subjected to Lateral Intersphincterotomy |
| Intervention |
Manual Anal Dilatation |
49 patients with chronic anal fissure underwent Manual Anal Dilatation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with Chronic Anal Fissure( ≥ 6 weeks of duration)
2) Age 20-60years.
3) Failed conservative management. (Not responded to conservative management of chronic anal fissure for ≥ 6weeks)
|
|
| ExclusionCriteria |
| Details |
1) Patients with Chronic Anal Fissure( ≥ 6 weeks of duration)
2) Age 20-60years.
3) Failed conservative management. (Not responded to conservative management of chronic anal fissure for ≥ 6weeks)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine post operative pain and incontinence in subjects with Chronic Anal Fissure undergoing Lateral Internal Sphincterotomy compared with Manual Anal Dilatation.
|
24 hours after surgery, at the time of discharge, 1st month, 2nd month and 3rd month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the rate of ulcer healing in Lateral Internal Sphincterotomy compared with Manual Anal Dilatation in subjects with Chronic Anal Fissure. |
24 hours after surgery, at the time of discharge, 1st month, 2nd month and 3rd month |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/10/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Two surgical methods are compared here. Manual anal dilatation is one of the ancient and simple surgery, but with high incidence of recurrence and incontinence. Lateral internal sphincterotomy is the most preferred procedure in the current days but again with incidence of incontinence.(3) Atleast 5 month follow up of 99 patients treated by sphincter stretch and reported recurrence rate of16%. Sphincterotomy results in sustained reduction of maximum resting anal pressure.(4) Hiltunen et al, found that the basal pressure was comparatively lower in the patients who underwent LIS, after 2 months of surgery,however, there were 4 failures among the 19 patients who underwent MAD. Many studies have demonstrated lower incontinence rate following LIS compared to MAD. Hareesh GSR et al described that in a sample of 60 patients, 4 (6.67%) patients were experiencing nocturnal soiling and 56 (93.33%) patients are not having nocturnal soiling. In MAD, 3 (10.0%) patients were experiencing Nocturnal soiling whereas in LAS, only 1 (3.3%) patient had Nocturnal soiling as complication. Rakesh Kumar et al described that, over the period of 9 month follow-up, 8 (16%) and 1 (2.27%) patients in LIS group and MAD group respectively reported with recurrence of symptoms and the fissure was evident on examination also (p = 0.05). |