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Pancreatic Exocrine Insufficiency After Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279653
Recruitment Status : Unknown
Verified September 2017 by Fatih Basak, Umraniye Education and Research Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Fatih Basak, Umraniye Education and Research Hospital

Brief Summary:
Main proposed benefit of sleeve gastrectomy is loss of ghrelin secreting tissue. Some studies express that ghrelin augment pancreatic regeneration. Therefore we hypothesized that with sleeve gastrectomy it may result with pancreatic insufficiency.

Condition or disease Intervention/treatment
Obesity, Morbid Pancreatic Insufficiency Procedure: SleeveGastrectomy

Detailed Description:

Mechanism of weight loss differs in bariatric surgery according to type of surgery.

With sleeve gastrectomy which has restrictive mechanism, ghrelin excretion decreases, and this condition is attributed as an additional mechanism in weight loss.

Ghrelin effects pancreatic regeneration, and loss of ghrelin may result with pancreatic insufficiency. Therefore we aimed to deteremine this association.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Sleeve Gastrectomy on Pancreatic Exocrine Insufficiency.
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : December 1, 2018

Group/Cohort Intervention/treatment
SleeveGastrectomy
Sleeve Gastrectomy will be performed. Preoperative and Postoperative pancreatic enzyme sufficiency (with steatocrit or fecal elastase) will be compared.
Procedure: SleeveGastrectomy
Preoperative enzyme test before and after sleeve gastrectomy. Sleeve Gastrectomy will be performed. Preoperative (in one month) and Postoperative (after 3 months) pancreatic enzyme sufficiency (with steatocrit or fecal elastase) will be compared.




Primary Outcome Measures :
  1. Pancreatic excorine enzyme difference [ Time Frame: post operative 3 months ]
    Effect of operation on pancreatic excorine enzyme



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are eligible for bariatric surgery with NIH criteria and American Society of Anesthesiologists (ASA)-Physical Status Classification System.
Criteria

Inclusion Criteria:

Patients underwent bariatric surgery (Sleeve gastrectomy) after concordonce with NIH criteria

Exclusion Criteria:

Additional operations to sleeve gastrectomy like duodenal switch. Other bariatric operations.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279653


Contacts
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Contact: Fatih Basak, MD (+0216 6321818 fatihbasak@gmail.com

Locations
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Turkey
Umraniye Education and Research Hospital Recruiting
Istanbul, Ümraniye, Turkey, 34000
Contact: Fatih Basak    5055034571    fatihbasak@gmail.com   
Sponsors and Collaborators
Umraniye Education and Research Hospital
Investigators
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Principal Investigator: Fatih Basak, MD University of Health Science, Umraniye Education and Research Hospital
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Responsible Party: Fatih Basak, M.D., Umraniye Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03279653    
Other Study ID Numbers: p-exocrine-insufficiency
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Exocrine Pancreatic Insufficiency
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pancreatic Diseases
Digestive System Diseases