| CTRI Number |
CTRI/2014/04/004563 [Registered on: 24/04/2014] Trial Registered Retrospectively |
| Last Modified On: |
23/04/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study role of antireflux procedures in patients of Achalasia cardia (motility disorder of food pipe due to which patients have difficulty in swallowing solids and liquids) undergoing surgery |
|
Scientific Title of Study
|
Role of antireflux procedures in Laparoscopic Heller cardiomyotomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pavithra B |
| Designation |
junior resident |
| Affiliation |
AIIMS |
| Address |
Room no 5026A, dept of surgery AIIMS, Ansari nagar
New Delhi
DELHI
110029
India |
| Phone |
9013949630 |
| Fax |
|
| Email |
pavitz86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajinder Parshad |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Dept of surgery, AIIMS, ansari nagar
New Delhi
DELHI
110029
India |
| Phone |
01126593462 |
| Fax |
|
| Email |
rajinder.parshad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajinder Parshad |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Dept of surgery, AIIMS, ansari nagar
New Delhi
DELHI
110029
India |
| Phone |
01126593462 |
| Fax |
|
| Email |
rajinder.parshad@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rajinder Parshad |
| Address |
Dept of surgery, AIIMS, Ansari nagar, New delhi- 110029 |
| Type of Sponsor |
Other [Investigator] |
|
|
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 Pavithra B |
AIIMS |
Room no. 5026A, dept of surgery, AIIMS, ansari nagar
New Delhi
DELHI |
9013949630
pavitz86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee for post graduate research, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Achalasia Cardia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laparoscopic Heller cardiomyotomy with Angle of His accentuation |
surgery |
| Comparator Agent |
Laparoscopic Heller cardiomyotomy with Dors fundoplication |
surgry |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All diagnosed patients of achalasia cardia planned for laproscopic cardiomyotomy.
2. Patients who are willing to give consent for the study.
3. Patients fit for General anesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Patient not willing to participate in the study.
2. Patient who are not fit for general anesthesia.
3. Patients undergoing re operation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| symptomactic relief- Dysphagia, regurgitation and heartburn, Quality of life |
1 week, 3 months and every 6 months thereafter |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| new onset reflux |
1 week, 3 months, every 6 months thereafter |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/02/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study was a continuation of previous thesis, with two groups- retrospective- follow up of patients previously operated and prospectively a randomised parallel group trial comparing two antireflux procedures namely Angle of His accentuation and Dor’s fundoplication in patients of Achalasia Cardia undergoing Laparoscopic Heller’s cardiomyotomy. Primary out come measure was symptomatic relief in terms of dysphagia, regurgitation, heartburn and quality of life. Secondary outcome was new onset heartburn. As the duration of the study, intervention and outcome measures were same as the previous study, a minimum sample size of 20 was calculated with 95% confidence interval and 80% power. We included all the patients enrolled in within the duration of the study from February 2012 to October 2013. |