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Robot-Assisted or Laparoscopic Resection for Gastric Subepithelial Tumor With Hand-Sewn Repair, a Case Series

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890354
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Study Description
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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.

Condition or disease Intervention/treatment
Gastric Mass Procedure: Hand-Sewn Repair

Detailed Description:
: A retrospective chart review was made of all patients who presented with gastric subepithelial tumor and underwent laparoscopic or robotic resection at Ramathibodi Hospital during 2012-2018. Surgical outcomes and complication of gastotomy and hand-sewn repair were analyzed.
Study Design
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Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Robot-Assisted or Laparoscopic Resection for Gastric Subepithelial Tumor With Hand-Sewn Repair, a Case Series
Actual Study Start Date : February 21, 2019
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : April 15, 2019

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Groups and Cohorts
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Intervention Details:
  • Procedure: Hand-Sewn Repair
    gastotomy to identify and remove gastric subepithelium tumor and hand sawn repair

Outcome Measures
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Primary Outcome Measures :
  1. Post operative complication [ Time Frame: 7 day ]
    anastomosis leak

  2. Post operative compliction [ Time Frame: 7 day ]
    wound infection


Secondary Outcome Measures :
  1. Surgical outcome [ Time Frame: 7 day ]
    Complete remove mass with out rupture


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
all patients who presented with gastric subepithelial tumor and underwent laparoscopic or robotic resection
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890354


Locations
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Thailand
Chairat Supsamutchai
Bangkok, Bankok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
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Study Chair: Chairat Supsamutchai, MD Faculty of Medicine Ramathibodi Hospital, Mahidol University.
More Information
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT03890354    
Other Study ID Numbers: 2018/1006
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases