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Status unknownNCT03279653Updated Sep 13, 2017

Pancreatic Exocrine Insufficiency After Bariatric Surgery

An observational study in Obesity, Morbid and Pancreatic Insufficiency, sponsored by Umraniye Education and Research Hospital. Status unknown at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-13.

Sponsored by Umraniye Education and Research Hospital · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity, Morbid
  • Pancreatic Insufficiency
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • SleeveGastrectomy

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

    Procedure: SleeveGastrectomy

Interventions

  • ProcedureSleeveGastrectomy

    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.

05

What researchers measure

Primary outcomes

  1. Pancreatic excorine enzyme difference

    Effect of operation on pancreatic excorine enzyme

    Time frame: post operative 3 months

06

Study locations

1 of 1 sites recruiting
  • Umraniye Education and Research Hospital
    Istanbul, Ümraniye 34000, Turkey
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03279653
Lead sponsor
Umraniye Education and Research Hospital
Responsible party
Fatih Basak (M.D., Umraniye Education and Research Hospital) — Principal investigator
First posted
Sep 12, 2017
Start date
Sep 1, 2017
Primary completion
Sep 1, 2018 (estimated)
Completion
Dec 1, 2018 (estimated)
Last update
Sep 13, 2017

Study contacts

Fatih Basak, MD
Contact
fatihbasak@gmail.com
(+0216 6321818
Fatih Basak, MD
principal investigator · University of Health Science, Umraniye Education and Research Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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