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THE EFFECT OF HELICOBACTER PYLORI ERADICATION THERAPY TO GASTRIC WALL THICKNESS BEFORE THE LAPAROSCOPIC SLEEVE GASTRECTOMY

Primary Purpose

Helicobacter Pylori Infection, Obesity, Morbid

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Bismuth Subsalicylate
Sponsored by
Fatih Sultan Mehmet Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Helicobacter Pylori Infection focused on measuring obesity, laparoscopic sleeve gastrectomy, helicobacter pylori, gastric wall thickness

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients who will undergo to LSG will have upper gastrointestinal system endoscopy before the surgery and positive HP results.

Exclusion Criteria:

  • Having allergy to the medications which use for the HP eradication therapy
  • The patients who is incompatible for the HP eradication therapy
  • The patients who decided to undergo to another bariatric surgery peroperatively

Sites / Locations

  • Fatih Sultan Mehmet Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

HP eradication therapy positive-HP positive

HP eradication therapy negative-HP positive

HP negative-Control group

Arm Description

who has HP positive endoscopic biopsy will take HP eradication therapy one month before the surgery

who has HP positive endoscopic biopsy and will not take any medication about HP

who has HP negative endoscopic biopsy and will not take any medication. (control group)

Outcomes

Primary Outcome Measures

measurements of gastric wall thickness
The effect of Helicobacter Pylori eradication therapy to the gastric wall thickness

Secondary Outcome Measures

Choosing the correct stapler colour during Laparoscopic Sleeve Gastrectomy by accounting gastric wall thickness thanks to knowing effect of HP positivity to gastric wall thickness

Full Information

First Posted
November 27, 2018
Last Updated
March 19, 2021
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03757650
Brief Title
THE EFFECT OF HELICOBACTER PYLORI ERADICATION THERAPY TO GASTRIC WALL THICKNESS BEFORE THE LAPAROSCOPIC SLEEVE GASTRECTOMY
Official Title
THE EFFECT OF HELICOBACTER PYLORI ERADICATION THERAPY TO GASTRIC WALL THICKNESS BEFORE THE LAPAROSCOPIC SLEEVE GASTRECTOMY
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatih Sultan Mehmet Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Laparoscopic sleeve gastrectomy is one of the most popular bariatric surgery in the world. The most important complication about this surgery that the leakage from the stapler line because of the inconvenient stapler choice..The stapler colour has to be chosen to the gastric wall thickness. It is not known well that the effect of Helicobacter pylori to gastric wall thickness Nobody pay any attention about being Helicobacter pylori positive when they are choosing stapler colour during the Laparoscopic sleeve gastrectomy so that everybody use the same type of stapler in Helicobacter pylori positive and negative patients during the Laparoscopic sleeve gastrectomy .Because of this inconvenient staplers use in the Laparoscopic sleeve gastrectomy the risk of leakage would be increase. Purpose of this research is that what is the effect of Helicobacter pylori to the gastric wall thickness and if the patients who will undergo Laparoscopic sleeve gastrectomy take the Helicobacter pylori eradication therapy before the surgery will gastric wall thickness increase or decrease. .
Detailed Description
All patients who will undergo to Laparoscopic sleeve gastrectomy have upper gastrointestinal system endoscopy before the surgery in our clinical routine. In our research some patients who has Helicobacter pylori positive endoscopic biopsy will take Helicobacter pylori eradication therapy one month before the surgery and some patients will not take any medication about Helicobacter pylori. All of gastric specimens( Helicobacter pylori positive or negative ) will examine microscopically in the pathology laboratory. The two groups which preoperatively Helicobacter pylori positive detected in endoscopic biopsy will compare with Helicobacter pylori negative control group. Control group will include 30 patients. The other two groups will include 44 patients for each group . The number of patients of group has been determined by power analysis. Gastric specimen will be examined by 3 points ; fundus, corpus, antrum. All of microscopic measurements will be done from that points from minor curvatura. These 3 points ; fundus( 1 cm from the top of staple line) , corpus (middle of the staple line) , antrum ( 1 cm far from the bottom of staple line ). All these points 5 mm far from the minor curvatura. These 3 points will examine about wall thickness (mucosa- submucosa-muscularis propria -serosa ) and the status of Helicobacter pylori. The end of the study it can be determined the effect of Helicobacter pylori to the gastric wall thickness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection, Obesity, Morbid
Keywords
obesity, laparoscopic sleeve gastrectomy, helicobacter pylori, gastric wall thickness

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HP eradication therapy positive-HP positive
Arm Type
Active Comparator
Arm Description
who has HP positive endoscopic biopsy will take HP eradication therapy one month before the surgery
Arm Title
HP eradication therapy negative-HP positive
Arm Type
Active Comparator
Arm Description
who has HP positive endoscopic biopsy and will not take any medication about HP
Arm Title
HP negative-Control group
Arm Type
No Intervention
Arm Description
who has HP negative endoscopic biopsy and will not take any medication. (control group)
Intervention Type
Drug
Intervention Name(s)
Bismuth Subsalicylate
Other Intervention Name(s)
amoxicillin, clarithromycin, omeprazole
Intervention Description
omeprazole 2x1) + clarithromycin 2x500 mg + amoxicilline 2x1000 mg + Bismuth Subsalicylate 2x1
Primary Outcome Measure Information:
Title
measurements of gastric wall thickness
Description
The effect of Helicobacter Pylori eradication therapy to the gastric wall thickness
Time Frame
one month
Secondary Outcome Measure Information:
Title
Choosing the correct stapler colour during Laparoscopic Sleeve Gastrectomy by accounting gastric wall thickness thanks to knowing effect of HP positivity to gastric wall thickness
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients who will undergo to LSG will have upper gastrointestinal system endoscopy before the surgery and positive HP results. Exclusion Criteria: Having allergy to the medications which use for the HP eradication therapy The patients who is incompatible for the HP eradication therapy The patients who decided to undergo to another bariatric surgery peroperatively
Facility Information:
Facility Name
Fatih Sultan Mehmet Research and Training Hospital
City
Istanbul
ZIP/Postal Code
34734
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

THE EFFECT OF HELICOBACTER PYLORI ERADICATION THERAPY TO GASTRIC WALL THICKNESS BEFORE THE LAPAROSCOPIC SLEEVE GASTRECTOMY

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