TISSUE SHRINKAGE DEPENDS ON FORMOL SOLUTION IN DIFFERENT GASTRIC LOCATIONS (SHRINKAGE)

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 Overview

• Status: Completed
• Conditions: Shrinking Stomach
• Intervention / Treatment: Procedure: shrinkage

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34734
    • Fatih Sultan Mehmet Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: shrinkage; shrinkage of gastric specimen in %10 formol solution after Laparoscopic Sleeve Gastrectomy
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	Procedure: shrinkage; shrinkage of gastric specimen in %10 formol solution after Laparoscopic Sleeve Gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
shrinkage in gastric tissue	shrinkage of gastric specimen in %10 formol solution after Laparoscopic Sleeve Gastrectomy	24 hours

Collaborators and Investigators

• Sponsor: Fatih Sultan Mehmet Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: stomach; shrinkage; formol; gastric wall
• Other Study ID Numbers: ANIL ERGIN.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No