ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03757650
Recruitment Status : Active, not recruiting
First Posted : November 29, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
ANIL ERGIN, Fatih Sultan Mehmet Training and Research Hospital

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. .

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Obesity, Morbid Drug: Bismuth Subsalicylate Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: THE EFFECT OF HELICOBACTER PYLORI ERADICATION THERAPY TO GASTRIC WALL THICKNESS BEFORE THE LAPAROSCOPIC SLEEVE GASTRECTOMY
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: HP eradication therapy positive-HP positive
who has HP positive endoscopic biopsy will take HP eradication therapy one month before the surgery
Drug: Bismuth Subsalicylate
omeprazole 2x1) + clarithromycin 2x500 mg + amoxicilline 2x1000 mg + Bismuth Subsalicylate 2x1
Other Names:
  • amoxicillin
  • clarithromycin
  • omeprazole

Active Comparator: HP eradication therapy negative-HP positive
who has HP positive endoscopic biopsy and will not take any medication about HP
Drug: Bismuth Subsalicylate
omeprazole 2x1) + clarithromycin 2x500 mg + amoxicilline 2x1000 mg + Bismuth Subsalicylate 2x1
Other Names:
  • amoxicillin
  • clarithromycin
  • omeprazole

No Intervention: HP negative-Control group
who has HP negative endoscopic biopsy and will not take any medication. (control group)



Primary Outcome Measures :
  1. measurements of gastric wall thickness [ Time Frame: one month ]
    The effect of Helicobacter Pylori eradication therapy to the gastric wall thickness


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757650


Locations
Turkey
Fatih Sultan Mehmet Research and Training Hospital
Istanbul, Turkey, 34734
Sponsors and Collaborators
Fatih Sultan Mehmet Training and Research Hospital

Responsible Party: ANIL ERGIN, Dr Anil ERGIN , General Surgery , Asistant doctor, Fatih Sultan Mehmet Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03757650     History of Changes
Other Study ID Numbers: ANIL ERGIN
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by ANIL ERGIN, Fatih Sultan Mehmet Training and Research Hospital:
obesity
laparoscopic sleeve gastrectomy
helicobacter pylori
gastric wall thickness

Additional relevant MeSH terms:
Omeprazole
Helicobacter Infections
Obesity, Morbid
Gram-Negative Bacterial Infections
Bacterial Infections
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Amoxicillin
Clarithromycin
Bismuth subsalicylate
Bismuth
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antacids
Antidiarrheals