Gastric Mass Clinical Trial
Official title:
Robot-Assisted or Laparoscopic Resection for Gastric Subepithelial Tumor With Hand-Sewn Repair, a Case Series
| NCT number | NCT03890354 |
| Other study ID # | 2018/1006 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 21, 2019 |
| Est. completion date | April 15, 2019 |
| Verified date | April 2019 |
| Source | Mahidol University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 27 |
| Est. completion date | April 15, 2019 |
| Est. primary completion date | March 30, 2019 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - all patients who presented with gastric subepithelial tumor and underwent laparoscopic or robotic resection at Ramathibodi Hospital during 2012-2018. Exclusion Criteria: - conversion to open surgery |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Chairat Supsamutchai | Bangkok | Bankok |
| Lead Sponsor | Collaborator |
|---|---|
| Mahidol University |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Post operative complication | anastomosis leak | 7 day | |
| Primary | Post operative compliction | wound infection | 7 day | |
| Secondary | Surgical outcome | Complete remove mass with out rupture | 7 day |