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Completed

NCT Number: NCT03757624

TISSUE SHRINKAGE DEPENDS ON FORMOL SOLUTION IN DIFFERENT GASTRIC LOCATIONS

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fatih Sultan Mehmet Research and Training Hospital

Istanbul, 34734, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

shrinkage

Procedure

shrinkage of gastric specimen in %10 formol solution after Laparoscopic Sleeve Gastrectomy

Primary outcomes

  1. shrinkage in gastric tissue

    Time frame: 24 hours

    shrinkage of gastric specimen in %10 formol solution after Laparoscopic Sleeve Gastrectomy

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Acronym: SHRINKAGE

Important dates

Study start
2018
Primary completion
2019
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.