Shrinking StomachSHRINKAGENCT03757624
TISSUE SHRINKAGE DEPENDS ON FORMOL SOLUTION IN DIFFERENT GASTRIC LOCATIONS
A study testing shrinkage in people with Shrinking Stomach, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Shrinking Stomach
- What is being tested?
- shrinkage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years old who will undergo to Laparoscopic Sleeve Gastrectomy
Who cannot join
- Patients who has to undergo another bariatric surgery type peroperatively
- Deformation of gastric specimen while removing from the abdomen
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Research and Training Hospital
Istanbul, 34734
About this study
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.
Read the 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.
- Conditions
- Shrinking Stomach
- Being tested
- shrinkage
- Keywords
- shrinkage, formol, stomach, gastric wall
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shrinkageProcedure or surgery
shrinkage of gastric specimen in %10 formol solution after Laparoscopic Sleeve Gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Gastric specimen measurements after 24 hours from % 10 formol | Active comparator | Gastric specimens of patients who will undergo to Laparoscopic Sleeve Gastrectomy ,will examine after formol solution Receives: Procedure: shrinkage |
| Gastric specimen measurements after surgery in operating room | Active comparator | Gastric specimens of patients who will undergo to Laparoscopic Sleeve Gastrectomy ,will examine after surgery in operating room peroperatively Receives: Procedure: shrinkage |
What is being measured
The primary outcome is the main question the study is designed to answer.
shrinkage in gastric tissue
shrinkage of gastric specimen in %10 formol solution after Laparoscopic Sleeve Gastrectomy
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Oct 2018
- Primary completion1 Nov 2019
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shrinking StomachStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANIL ERGIN, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757624
- Sponsor's protocol ID
- ANIL ERGIN.
- Acronym
- SHRINKAGE
- Status last verified
- Mar 2021
- First submitted
- 27 Nov 2018
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TISSUE SHRINKAGE DEPENDS ON FORMOL SOLUTION IN DIFFERENT GASTRIC LOCATIONS
- ClinicalTrials.gov ID
- NCT03757624
- Acronym / sponsor ID
- SHRINKAGE / ANIL ERGIN.
- Conditions
- Shrinking Stomach
- Keywords
- shrinkage, formol, stomach, gastric wall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric specimen measurements after 24 hours from % 10 formol | Active comparator | Procedure: shrinkageGastric specimens of patients who will undergo to Laparoscopic Sleeve Gastrectomy ,will examine after formol solution |
| Gastric specimen measurements after surgery in operating room | Active comparator | Procedure: shrinkageGastric specimens of patients who will undergo to Laparoscopic Sleeve Gastrectomy ,will examine after surgery in operating room peroperatively |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 18 years old who will undergo to Laparoscopic Sleeve Gastrectomy
Key exclusion criteria (2 listed)
- Patients who has to undergo another bariatric surgery type peroperatively
- Deformation of gastric specimen while removing from the abdomen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shrinkageshrinkage of gastric specimen in %10 formol solution after Laparoscopic Sleeve Gastrectomy | Procedure or surgery | Gastric specimen measurements after 24 hours from % 10 formol, Gastric specimen measurements after surgery in operating room |
Primary outcome
shrinkage in gastric tissue
Time frame: 24 hours
shrinkage of gastric specimen in %10 formol solution after Laparoscopic Sleeve Gastrectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shrinkage in people with Shrinking Stomach, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shrinkage in gastric tissue (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.