NCT04111393

Brief Summary

Investigators aimed to present the patients who underwent laparoscopic gastrectomy with transoral specimen extraction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
Last Updated

October 1, 2019

Status Verified

January 1, 2014

Enrollment Period

9 months

First QC Date

September 29, 2019

Last Update Submit

September 30, 2019

Conditions

Gastric DiseaseBariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

transoral specimen extractionPROCEDURE

transoral specimen extraction during laparoscopic gastric resection

Also known as: laparoscopic gastric resection

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • laparoscopic gastric resection
  • Patients aged 18-70 years

You may not qualify if:

  • other transorally removed organs (appendix, gallbladder, surrenal)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cihan Gokler

Malatya, 44090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stomach Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Inonu

Study Record Dates

First Submitted

September 29, 2019

First Posted

October 1, 2019

Study Start

January 1, 2019

Primary Completion

September 20, 2019

Study Completion

September 28, 2019

Last Updated

October 1, 2019

Record last verified: 2014-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)