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NCT03279653 Clinical Trial

Pancreatic Exocrine Insufficiency After Bariatric Surgery

Obesity, Morbid Clinical Trial

Official title:
Effect of Sleeve Gastrectomy on Pancreatic Exocrine Insufficiency.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03279653
Other study ID # p-exocrine-insufficiency
Secondary ID
Status Recruiting
Phase N/A
First received September 8, 2017
Last updated September 12, 2017
Start date September 1, 2017
Est. completion date December 1, 2018

Study information
Verified date September 2017
Source Umraniye Education and Research Hospital
Contact Fatih Basak, MD
Phone (+0216 6321818
Email fatihbasak@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 1, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Turkey Umraniye Education and Research Hospital Istanbul Ümraniye

Sponsors (1)
Lead Sponsor Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pancreatic excorine enzyme difference Effect of operation on pancreatic excorine enzyme post operative 3 months
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