| CTRI Number |
CTRI/2020/07/026866 [Registered on: 28/07/2020] Trial Registered Prospectively |
| Last Modified On: |
22/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness Of Yoga In Incisional And Ventral Hernia Patients |
|
Scientific Title of Study
|
Effect Of Yoga Therapy On Quality Of Life In Patients Undergoing Laparoscopic Incisional And Ventral Hernia Repair- A Randomized Control Trial |
| Trial Acronym |
YT-LIAR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raghunandan Dixit |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 5026A, 5th floor,Teaching BLock, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9650941820 |
| Fax |
|
| Email |
raghu.aiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Om Prakash |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of surgical disciplines, CMET surgery office, AIIMS, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8003991303 |
| Fax |
|
| Email |
drprajapatiom@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Om Prakash |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of surgical disciplines, CMET surgery office, AIIMS, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8003991303 |
| Fax |
|
| Email |
drprajapatiom@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Ansari Nagar, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Om Prakash |
All India Institute of Medical Sciences, New Delhi, India |
Department of Surgical Disciplines Ansari Nagar, New Delhi-110029 South DELHI
New Delhi
DELHI
New Delhi
DELHI |
8003991303
drprajapatiom@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K432||Incisional hernia without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Laparoscopic incisional and ventral hernia repair for incisional and ventral hernia |
Incisional and ventral hernia patients will undergo laparoscopic incisional and ventral hernia surgery at scheduled time with no yoga therapy |
| Intervention |
Yoga therapy in patients undergoing laparoscopic incisional and ventral hernia surgery for incisional and ventral hernia |
Yoga therapy administered in two modules in preoperative and postoperative phases. Yoga module will include loosening practices, breathing practices, asanas, pranayama, bandha and relaxation exercises. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age group 18-60 years
2. Undergoing laparoscopic incisional/ventral hernia repair for primary and recurrent ventral/incisional hernia
3. Defect size <6cm |
|
| ExclusionCriteria |
| Details |
• Incisional hernia >6cm in size
• Complicated incisional hernia (strangulated or obstructed hernia)
• Physical inability to do yoga exercises
• Patients unfit for general anesthesia
• Patients with uncontrolled coagulopathy
• Severe cardiac or respiratory insufficiency
• Patients who refuse to consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare effect of Yoga therapy on quality of life in patients undergoing laparoscopic incisional and ventral hernia repair |
At 1 month before surgery, 1 day after surgery, 7 days after surgery, 1 month and 3 months after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of yoga therapy on following in patients undergoing incisional and ventral hernia repair-
1. Depression, anxiety and stress assessment
2. Post-operative pain
3. Analgesic requirement
4. Antiemetic requirement
5. Pulmonary function test
6. Sleep
|
1. at 1 month before surgery
2. 1 day after surgery
3. 7 days after surgery
4. 1 month
5. 3 months after surgery |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/08/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Yoga has diverse effects on human body and has been proven in many diseases, and no study has been conducted to evaluate its effects in patients undergoing incisional and ventral hernia surgery. Incisional and ventral hernia patients report dull aching pain, poor quality of life and impaired sleep quality and yoga therapy and shown improvement in these outcomes, so this study is been conducted. Patients undergoing laparoscopic mesh repair report significant pain after surgery and thus quality of life is affected. So this study is conducted.
|