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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03757650
• Other study ID #: ANIL ERGIN
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2018
• Est. completion date: February 1, 2021

Study information

• Verified date: March 2021
• Source: Fatih Sultan Mehmet Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Pylori Infection
• Obesity, Morbid

Intervention

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

Locations

Country	Name	City	State
Turkey	Fatih Sultan Mehmet Research and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurements of gastric wall thickness	The effect of Helicobacter Pylori eradication therapy to the gastric wall thickness	one month
Secondary	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		one month