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Completed

NCT Number: NCT03757650

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

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. .

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fatih Sultan Mehmet Research and Training Hospital

Istanbul, 34734, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bismuth Subsalicylate

Drug

omeprazole 2x1) + clarithromycin 2x500 mg + amoxicilline 2x1000 mg + Bismuth Subsalicylate 2x1

Other names: amoxicillin, clarithromycin, omeprazole

Primary outcomes

  1. measurements of gastric wall thickness

    Time frame: one month

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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Nov 29, 2018
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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