Pancreatic Exocrine Insufficiency After Bariatric Surgery | NCT03279653

Studies
Pancreatic Exocrine Insufficiency After Bariatric Surgery

NCT03279653

Sponsor

Umraniye Education and Research Hospital

Status

Unknown status

Last Update Posted

Sep 13, 2017Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Obesity, Morbid
Pancreatic Insufficiency

Interventions

SleeveGastrectomy

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Sep 1, 2018Estimated

Completion Date

Dec 1, 2018Estimated

First Submitted Date

Sep 8, 2017

First Submission Date that Met QC Criteria

Sep 8, 2017

First Posted Date

Sep 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2017

Last Update Posted Date

Sep 13, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fatih Basak, M.D., Umraniye Education and Research HospitalPrincipal Investigator

Lead Sponsor

Umraniye Education and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SleeveGastrectomy		Sleeve Gastrectomy will be performed. Preoperative and Postoperative pancreatic enzyme sufficiency (with steatocrit or fecal elastase) will be compared.	Procedure: SleeveGastrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SleeveGastrectomy	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pancreatic excorine enzyme difference	Effect of operation on pancreatic excorine enzyme	post operative 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who are eligible for bariatric surgery with NIH criteria and American Society of Anesthesiologists (ASA)-Physical Status Classification System.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fatih Basak, MD	Contact	(+0216 6321818		fatihbasak@gmail.com

Overall Officials

Name	Affiliation	Role
Fatih Basak, MD	University of Health Science, Umraniye Education and Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Umraniye Education and Research Hospital	Recruiting	Istanbul	Ümraniye	34000	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid
D010188	Exocrine Pancreatic Insufficiency

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

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Browse Branches

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