NCT03890354

Brief Summary

There are a lot of surgical techniques in minimally-invasive surgery to remove gastric subepithelium tumor. Surgical approach depend on location and size of tumor. Usefully used Endostapler to cut stomach include lesion. For tumors in difficult locations some surgeons prefer laparoscopic and endoscopic cooperation or use the intragastric port technique to identify and remove the mass. But in complex procedures, gastotomy and hand sawn to identify and remove gastric subepithelium tumor is a simple technique and easy to apply. This study demonstrates the safety and effectiveness of this technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 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

February 21, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

1 month

First QC Date

March 24, 2019

Last Update Submit

April 17, 2019

Conditions

Gastric Mass

Outcome Measures

Primary Outcomes (2)

  • Post operative complication

    anastomosis leak

    7 day

  • Post operative compliction

    wound infection

    7 day

Secondary Outcomes (1)

  • Surgical outcome

    7 day

Interventions

Hand-Sewn RepairPROCEDURE

gastotomy to identify and remove gastric subepithelium tumor and hand sawn repair

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients who presented with gastric subepithelial tumor and underwent laparoscopic or robotic resection

You may qualify if:

  • all patients who presented with gastric subepithelial tumor and underwent laparoscopic or robotic resection at Ramathibodi Hospital during 2012-2018.

You may not qualify if:

  • conversion to open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chairat Supsamutchai

Bangkok, Bankok, 10400, Thailand

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Chairat Supsamutchai, MD

    Ramathibodi Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2019

First Posted

March 26, 2019

Study Start

February 21, 2019

Primary Completion

March 30, 2019

Study Completion

April 15, 2019

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)