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CTRI Number  CTRI/2011/05/001717 [Registered on: 09/05/2011] Trial Registered Retrospectively
Last Modified On: 06/05/2011
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects in Sleeve Gastrectomy Patients in Morbid Obesity and related Diseases. 
Scientific Title of Study   A Randomised study of LinEar Staple Line Reinforcement in Sleeve Gastrectomy Patients using Peristrips Dry with Veritas Collagen Matrix . 
Trial Acronym  SEAL 
Secondary IDs if Any  
Secondary ID  Identifier 
PM-0902, Rev A-1.  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shashank Shah 
Designation  consulting laparoscopic and bariatric surgeon 
Affiliation  consulting laparoscopic and bariatric surgeon 
Address  40, Sassoon Road, Cancer Building first Floor, OPD No. 104, Pune-411001.
40, Sassoon Road, Cancer Building first Floor, OPD No. 104, Pune-411001
Pune
MAHARASHTRA
411001.
India 
Phone  91-9822026734  
Fax  91-20-26124529  
Email  drshashanks@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashank Shah 
Designation  consulting laparoscopic and bariatric surgeon 
Affiliation  consulting laparoscopic and bariatric surgeon 
Address  40, Sassoon Road, Cancer Building first Floor, OPD No. 104, Pune-411001.
40, Sassoon Road, Cancer Building first Floor, OPD No. 104, Pune-411001
Pune
MAHARASHTRA
411001.
India 
Phone  91-9822026734  
Fax  91-20-26124529  
Email  drshashanks@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayashree Todkar 
Designation  consulting laparoscopic and bariatric surgeon 
Affiliation  consulting laparoscopic and bariatric surgeon 
Address  40, Sassoon Road, Cancer Building first Floor, OPD No. 104, Pune-411001
40, Sassoon Road, Cancer Building first Floor, OPD No. 104, Pune-411001
Pune
MAHARASHTRA
411001
India 
Phone  9--9823090505  
Fax  91-20-26124529  
Email  jayatodkar@hotmail.com  
 
Source of Monetary or Material Support  
Synovis Surgical Innovations 
 
Primary Sponsor  
Name  Synovis Surgical Innovations 
Address  Synovis Surgical Innovations, 2575 University Ave, St. Paul, MN 55114,USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jayshree Todkar  Poona Hospital and Research Centre  27, Sadashiv peth, Pune-411003
Pune
MAHARASHTRA 		 09823090505
02024338477
jayatodkar@hotmail.com 
Dr jayashree Todkar  Ruby Hall Clinic  40, Sassoon Road, Pune- 411001
Pune
MAHARASHTRA 		 09823090505
02026124529
jayatodkar@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee, Poona Hospital and Research Centre  Approved 
Poona Medical Research Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Morbid obesity and related diseases.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention and comparator agent CONTROL ARM VERSUS PSDV ARM.   Intervention and comparator agent. In CONTROL ARM PSDV product will not be used, while in PSDV ARM, PSDV product will be used during stappeling of stomach pouch.  
Comparator Agent  Peristrips Device veritas  Peristrips is a device used while staplling the stomach pouch. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Adult males or females with a age between 18-75 yrs.
2.subject /LAR must be able to give written informed consent form.
3 Must have a BMI 32.5kg/m2 with one or more co morbidities or BMI 37.5kg/m2.
4. Must be willing and able to return for follow up visits.
5 Subject should be a good candidate for sleeve Gastrectomy. 
 
ExclusionCriteria 
Details  1.Subject must not have previous or known allergy or sensitivity to bovine products.
2. No previous abdominal history that could affect the outcome of the trial.
3. Uncontrolled Hypertension. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the staple line bleeds and staple line leaks associated with the use of PSDV as staple line reinforcement during LSG surgery versus a control group.  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the Operating room time and the number of clips and or sutures used to control bleeding in the PSDV group versus the control group.  18 months. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   08/04/2010 
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)  Open to Recruitment 
Publication Details   None as yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Obesity is an epidemic that is becoming recognized as a major public health risk throughout the world.  The World Health Organization reports that 1.6 billion adults are overweight worldwide and at least 400 million are clinically obese.1 Obesity often occurs in developing countries in tandem with under-nutrition and affects nearly all ages and socioeconomic groups.2  In India, approximately 30-65% of  the population is considered overweight, obese or have abdominal obesity. The rising percentage of obese people in India is contributing to the global increase in obesity-related comorbidities such as hypertension, type 2 diabetes mellitus and cardiovascular disease.3

 

According to the Consensus Statement for Diagnosis of Obesity, Abdominal Obesity and the Metabolic Syndrome for Asian Indians and Recommendations for Physical Activity, Medical and Surgical Management, an Indian is considered overweight with a Body Mass Index (BMI) of 23.0 – 24.9 kg/m2 and obese with a BMI of greater than 25 kg/m2.3

 

There are a number of medical, dietary, and surgical options for the treatment of obesity.  Medical and dietary options are typically attempted prior to performing gastric surgery.  The Consensus Statement for Asian Indians recommends pharmacotherapy for people with a BMI greater than 25 kg/m2 with an associated comorbidity or greater than 27 kg/m2 without a comorbidity. Gastric surgery is recommended for a BMI above 32.5 kg/m2 with a comorbidity or 37.5 kg/m2 without a comorbidity.3  

 

In sleeve gastrectomy surgery, staple line leaks and staple line bleeding are two common reportable events.  Surgeons throughout the world performing sleeve gastrectomy surgery have found the use of a buttress material to be beneficial.  Peri-Strips Dry® with Veritas® (PSDV) manufactured by Synovis Surgical Innovations has been used to reinforce staple lines thus preventing serious adverse events.  This product has been cleared for use in the US and India and has received CE Mark in Europe. This clinical trial is being conducted to evaluate the complication rates of PSDV as staple line reinforcement during sleeve gastrectomy surgery.

 

 
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