Gastric DiseaseNCT04111393
Transoral Removal of Specimen During Laparoscopic Gastric Resection
An observational study of Gastric Disease and Bariatric Surgery Candidate, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Investigators aimed to present the patients who underwent laparoscopic gastrectomy with transoral specimen extraction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Disease, Bariatric Surgery Candidate
- What is being tested?
- transoral specimen extraction
- Type of treatment
- Surgery or procedure
- How many people
- 4 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 28 Sep 2019
- Phase
- Observational
- 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
Study population: patients who underwent sleeve gastrectomy for morbid obesity, subtotal gastrectomy for pyloric obstruction, and extensive gastric resection for gastrointestinal stromac tumor
Who may be able to join
- laparoscopic gastric resection
- Patients aged 18-70 years
Who cannot join
- other transorally removed organs (appendix, gallbladder, surrenal)
Trial locations and contacts
1 site in 1 country.
About this study
Investigators aimed to present the patients who underwent laparoscopic gastrectomy with transoral specimen extraction.
Read the detailed description
Minimally invasive surgical procedures such as NOSE (Natural orifice spesmen extraction) and NOTES (Natural orifice translumenal endoscopic surgery) are gradually increasing. The transoral way is probably the least used for NOSE.
- Conditions
- Gastric Disease, Bariatric Surgery Candidate
- Being tested
- transoral specimen extraction
- Medical subject headings
- Stomach Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transoral specimen extractionProcedure or surgery
Also called laparoscopic gastric resection
transoral specimen extraction during laparoscopic gastric resection
What is being measured
The primary outcome is the main question the study is designed to answer.
Transoral Specimen Extraction During Laparoscopic Gastric Resection
laparoscopic gastric resections due to sleeve gastrectomy or pyloric obstruction will be observed after transoral removal.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Jan 2019
- Primary completion20 Sep 2019
- Study completion28 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric DiseaseStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, cihan gokler, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111393
- Sponsor's protocol ID
- 2019/2-4
- Status last verified
- Jan 2014
- First submitted
- 29 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patients who underwent laparoscopic gastric resection with transoral extraction between 2014-2018 in Inonu University gastroenterology surgery clinic will be evaluated retrospectively. Patients will be evaluated in terms of age, sex, indication for surgery, operation, number and diameter of ports used, duration of surgery, intraoperative and postoperative complications, duration of hospitalization.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transoral Removal of Specimen During Laparoscopic Gastric Resection
- ClinicalTrials.gov ID
- NCT04111393
- Acronym / sponsor ID
- 2019/2-4
- Conditions
- Gastric Disease, Bariatric Surgery Candidate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 28 Sep 2019 (actual)
- First posted
- 1 Oct 2019 (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.
Investigators aimed to present the patients who underwent laparoscopic gastrectomy with transoral specimen extraction.
Detailed description
Minimally invasive surgical procedures such as NOSE (Natural orifice spesmen extraction) and NOTES (Natural orifice translumenal endoscopic surgery) are gradually increasing. The transoral way is probably the least used for NOSE.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent sleeve gastrectomy for morbid obesity, subtotal gastrectomy for pyloric obstruction, and extensive gastric resection for gastrointestinal stromac tumor
Key inclusion criteria (2 listed)
- laparoscopic gastric resection
- Patients aged 18-70 years
Key exclusion criteria (1 listed)
- other transorally removed organs (appendix, gallbladder, surrenal)
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 |
|---|---|---|
| transoral specimen extractionAlso: laparoscopic gastric resectiontransoral specimen extraction during laparoscopic gastric resection | Procedure or surgery | – |
Primary outcome
Transoral Specimen Extraction During Laparoscopic Gastric Resection
Time frame: 2 years
laparoscopic gastric resections due to sleeve gastrectomy or pyloric obstruction will be observed after transoral removal.
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 1 Oct 2019.
- Individual participant dataSharing planned: No. The patients who underwent laparoscopic gastric resection with transoral extraction between 2014-2018 in Inonu University gastroenterology surgery clinic will be evaluated retrospectively. Patients will be evaluated in terms of age, sex, indication for surgery, operation, number and diameter of ports used, duration of surgery, intraoperative and postoperative complications, duration of hospitalization.
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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?
An observational study of Gastric Disease and Bariatric Surgery Candidate, run by Inonu University 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 2 inclusion and 1 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 1 Oct 2019. 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?
Transoral Specimen Extraction During Laparoscopic Gastric Resection (time frame: 2 years). 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 1 Oct 2019.