- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04111393
Transoral Removal of Specimen During Laparoscopic Gastric Resection
September 30, 2019 updated by: cihan gokler, Inonu University
Investigators aimed to present the patients who underwent laparoscopic gastrectomy with transoral specimen extraction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Malatya, Turkey, 44090
- Cihan Gökler
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients who underwent sleeve gastrectomy for morbid obesity, subtotal gastrectomy for pyloric obstruction, and extensive gastric resection for gastrointestinal stromac tumor
Description
Inclusion Criteria:
- laparoscopic gastric resection
- Patients aged 18-70 years
Exclusion Criteria:
- other transorally removed organs (appendix, gallbladder, surrenal)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
September 20, 2019
Study Completion (Actual)
September 28, 2019
Study Registration Dates
First Submitted
September 29, 2019
First Submitted That Met QC Criteria
September 30, 2019
First Posted (Actual)
October 1, 2019
Study Record Updates
Last Update Posted (Actual)
October 1, 2019
Last Update Submitted That Met QC Criteria
September 30, 2019
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/2-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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