Pancreatic Exocrine Insufficiency After Bariatric Surgery

Sponsor

Umraniye Education and Research Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03279653

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effect of Sleeve Gastrectomy on Pancreatic Exocrine Insufficiency.

Actual Study Start Date :

Sep 1, 2017

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Pancreatic excorine enzyme difference [post operative 3 months]
Effect of operation on pancreatic excorine enzyme

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Umraniye Education and Research Hospital	Istanbul	Ümraniye	Turkey	34000

Sponsors and Collaborators

Umraniye Education and Research Hospital

Investigators

Principal Investigator: Fatih Basak, MD, University of Health Science, Umraniye Education and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fatih Basak, M.D., Umraniye Education and Research Hospital

ClinicalTrials.gov Identifier:

NCT03279653

Other Study ID Numbers:

p-exocrine-insufficiency

First Posted:

Sep 12, 2017

Last Update Posted:

Sep 13, 2017

Last Verified:

Sep 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Exocrine Pancreatic Insufficiency

Obesity, Morbid

Study Results

No Results Posted as of Sep 13, 2017