Transoral Removal of Specimen During Laparoscopic Gastric... | NCT04111393

Studies
Transoral Removal of Specimen During Laparoscopic Gastric Resection

NCT04111393

Sponsor

Inonu University

Status

Completed

Last Update Posted

Oct 1, 2019Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Gastric Disease
Bariatric Surgery Candidate

Interventions

transoral specimen extraction

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Sep 20, 2019Actual

Completion Date

Sep 28, 2019Actual

First Submitted Date

Sep 29, 2019

First Submission Date that Met QC Criteria

Sep 30, 2019

First Posted Date

Oct 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2019

Last Update Posted Date

Oct 1, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transoral specimen extraction	Procedure	transoral specimen extraction during laparoscopic gastric resection		laparoscopic gastric resection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Transoral Specimen Extraction During Laparoscopic Gastric Resection	laparoscopic gastric resections due to sleeve gastrectomy or pyloric obstruction will be observed after transoral removal.	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

laparoscopic gastric resection
Patients aged 18-70 years

Exclusion Criteria:

other transorally removed organs (appendix, gallbladder, surrenal)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

patients who underwent sleeve gastrectomy for morbid obesity, subtotal gastrectomy for pyloric obstruction, and extensive gastric resection for gastrointestinal stromac tumor

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cihan Gokler		Malatya		44090	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013272	Stomach Diseases

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided