| CTRI Number |
CTRI/2017/01/007674 [Registered on: 11/01/2017] Trial Registered Retrospectively |
| Last Modified On: |
26/12/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Video assisted anal fistula treatment for personal fistula |
|
Scientific Title of Study
|
A PROSPECTIVE STUDY OF 50 CASES OF VIDEO ASSISTED ANAL FISTULECTOMY |
| Trial Acronym |
VAAFT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramkrishna Darji |
| Designation |
surgery resident |
| Affiliation |
govt.medical college bhavnagar |
| Address |
ROOM NO 603
PG3 DHANVATRI HOSTEL
SIR T HOSPITAL CAMPUS
BHAVNAGAR 364001
INDRAPRASTH BUNGLOWS EGOLA ROAD
ABU ROAD
PALANPUR 385001
Banas Kantha
GUJARAT
364001
India |
| Phone |
9033866631 |
| Fax |
|
| Email |
rddarji15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samir M shah |
| Designation |
Head of department, Department of Surgery |
| Affiliation |
Government medical college and sir t hospital bhavnagar |
| Address |
Government medical college and sir t hospital bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427215253 |
| Fax |
|
| Email |
shah.samir@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samir M shah |
| Designation |
Head of department, Department of Surgery |
| Affiliation |
Government medical college and sir t hospital bhavnagar |
| Address |
Government medical college and sir t hospital bhavnagar
Narmada
GUJARAT
364001
India |
| Phone |
9427215253 |
| Fax |
|
| Email |
shah.samir@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Government medicl college and sir t hospital bhavnagar |
|
|
Primary Sponsor
|
| Name |
Government medicl college and sir t hospital bhavnagar |
| Address |
department of surgery
Government medicl college and sir t hospital
jail road
bhavnagar 364001 gujarat |
| Type of Sponsor |
Government 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 |
| dr ramkrihna darji |
government medical college and sir t hospital bhavnagar |
department of surgery
government medical college and sir t hospital
jail road bhavnagar 364001 gujarat
Bhavnagar
GUJARAT |
9033866631
rddarji15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Govt. Medical College,Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PERIANAL FISTULA PATIENTS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
VAAFT |
In VAAFT surgery we introduce fistuloscope through external opening and visualize internal opening which was closed with suture and endo cautery in single sitting |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
PT FIT FR SURGICAL INTERVENTION
COMPLEX ANAL FISTULA |
|
| ExclusionCriteria |
| Details |
UNCONTROLLED DM
CHRONS DISEASE
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vaaft is minimaly invasive,easy,sphincter saving,day care surgery for perianal fistula |
0 day
15 days
1 month
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vaaft is minimaly invasive,easy,sphincter saving,day care surgery for perianal fistula |
0 day
15 days
1 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
29/09/2015 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Peri anal fistula is chronic abnormal epithelialiazed communication between peri anal skim and mucosa. More comman in male in the age group of 20-50 year Patient presented with complaining of peri anal pain,ithcing,discharg Perianal fistula diagnosed by doing sonogram,proctoscopy and MRI.Among this MRI is gold standard for making diagnosis of fistula. Treatment of fistula is surgery.various surgical modalities available Main aim of surgery is identification of internl opening,minimal invasion,least injury to anal sphincter and less post operative hospital stay. In most of the surgical procedure there is chances of sphictr involvement,reccurance,and longer post operative hospital stay. VAAFT by direct visualization of internal opening of fitula with closure of it,minimal involvement of anal sphincter with short duration of hospital stay,easy to perform best treatment modality for the management of peri anal fistula.
|