TISSUE SHRINKAGE DEPENDS ON FORMOL SOLUTION IN DIFFERENT GASTRIC LOCATIONS

Overview

Generally % 10 formol solution is use to do fixation to all specimens after the surgical operations for the pathological evaluation. It is known that the formol solution cause amount of shrinkage in the tissue volume . This effect of formol solution had researched in colon,breast and prostate previously. But there is no evidence about stomach. The purpose of this research is that find out the formol effect to the gastric tissue and detect the shrinkage percent.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 1, 2019

Detailed Description

All gastric specimens which removed after Laparoscopic Sleeve Gastrectomy will open from the major curvature and spread down to the table.in operating room..3 cm x 3 cm three tissue samples will collect from the specific locations. These three locations are ; fundus( 1 cm from the top of staple line) , corpus (middle of the major curvature , antrum ( 1 cm far from the bottom of staple line ). All these points 5 mm far from the major curvature. 6 samples will prepare totally. 2 samples for each location ; one mucosa and one all layer of gastric wall for each location .These 3 points will examine about wall thickness(mucosa- submucosa-muscularis propria -serosa ) After saving the measurements in operating room;the gastric specimen will deliver to a pathologist to put the specimen into the % 10 formol solution. After 24 hours ;pathologist will save all of new measurements same in operating room. The measurements of sample are ;height , length , width . After the completion of the measurements the investigator will compare the results found in operating room in fresh specimen with pathologist 's results after formol. After that the investigator will be able to decide the shrinkage of gastric tissue in % 10 formol solution.

Interventions

  • Procedure: shrinkage
    • shrinkage of gastric specimen in formol solution after Laparoscopic Sleeve Gastrectomy

Arms, Groups and Cohorts

  • Active Comparator: Gastric specimen measurements after 24 hours from % 10 formol
    • Gastric specimens of patients who will undergo to Laparoscopic Sleeve Gastrectomy ,will examine after formol solution
  • Active Comparator: Gastric specimen measurements after surgery in operating room
    • Gastric specimens of patients who will undergo to Laparoscopic Sleeve Gastrectomy ,will examine after surgery in operating room peroperatively

Clinical Trial Outcome Measures

Primary Measures

  • shrinkage in gastric tissue
    • Time Frame: 24 hours
    • shrinkage of gastric specimen in formol solution after Laparoscopic Sleeve Gastrectomy

Participating in This Clinical Trial

Inclusion Criteria

  • Patients older than 18 years old who will undergo to Laparoscopic Sleeve Gastrectomy Exclusion Criteria:

  • Patients who has to undergo another bariatric surgery type peroperatively – Deformation of gastric specimen while removing from the abdomen

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fatih Sultan Mehmet Training and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: ANIL ERGIN, asistant doctor – Fatih Sultan Mehmet Training and Research Hospital

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