NCT03279653

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

September 8, 2017

Last Update Submit

September 12, 2017

Conditions

Obesity, MorbidPancreatic Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Pancreatic excorine enzyme difference

    Effect of operation on pancreatic excorine enzyme

    post operative 3 months

Study Arms (1)

SleeveGastrectomy

Sleeve Gastrectomy will be performed. Preoperative and Postoperative pancreatic enzyme sufficiency (with steatocrit or fecal elastase) will be compared.

Procedure: SleeveGastrectomy

Interventions

SleeveGastrectomyPROCEDURE

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.

SleeveGastrectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umraniye Education and Research Hospital

Istanbul, Ümraniye, 34000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Obesity, MorbidExocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPancreatic DiseasesDigestive System Diseases

Study Officials

  • Fatih Basak, MD

    University of Health Science, Umraniye Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatih Basak, MD

CONTACT

(+0216 6321818fatihbasak@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

September 8, 2017

First Posted

September 12, 2017

Study Start

September 1, 2017

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

September 13, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)