Back to resultsTransgastric Peritoneoscopy and Appendectomy
Primary Purpose
Abdominal Pain
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Transgastric peritoneoscopy (NOTES)
Sponsored by
About this trial
This is an interventional diagnostic trial for Abdominal Pain focused on measuring NOTES, Transgastric, Appendectomy, Safety, Feasibility
Eligibility Criteria
Inclusion Criteria:
- Patient with acute abdominal pain
Exclusion Criteria:
- Patient under 18
- Patient who cannot understand information in Swedish
- Patients previously operated in upper part of the abdomen
Sites / Locations
- Department of Surgery, South Alvsborg HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transgastric peritoneoscopy
Arm Description
Only one arm, feasibility study
Outcomes
Primary Outcome Measures
To test the feasibility of transgastric peritoneoscopy
Secondary Outcome Measures
Full Information
NCT ID
NCT00952146
First Posted
June 15, 2009
Last Updated
August 4, 2009
Sponsor
Sodra Alvsborgs Hospital
Collaborators
Borås Lasarett
1. Study Identification
Unique Protocol Identification Number
NCT00952146
Brief Title
Transgastric Peritoneoscopy and Appendectomy
Official Title
Transgastric Diagnostic Peritoneoscopy (Laparoscopy) and Appendectomy - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sodra Alvsborgs Hospital
Collaborators
Borås Lasarett
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a feasibility study. Patients with acute abdominal pain who are planning to undergo a diagnostic laparoscopy are asked to participate in the study. The aim of the study is to evaluate if transgastric peritoneoscopy is feasible.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
Keywords
NOTES, Transgastric, Appendectomy, Safety, Feasibility
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transgastric peritoneoscopy
Arm Type
Experimental
Arm Description
Only one arm, feasibility study
Intervention Type
Procedure
Intervention Name(s)
Transgastric peritoneoscopy (NOTES)
Other Intervention Name(s)
No more interventions
Intervention Description
Under general anesthesia an endoscope will be passed through the gastric wall into the peritoneal cavity to examine the peritoneal cavity. At the withdrawal of the endoscope, the gastric access in the stomach wall will be closed with T-tags.
Primary Outcome Measure Information:
Title
To test the feasibility of transgastric peritoneoscopy
Time Frame
When discharged from hospital, 1 month post-op and one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with acute abdominal pain
Exclusion Criteria:
Patient under 18
Patient who cannot understand information in Swedish
Patients previously operated in upper part of the abdomen
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Per-Ola Park, MD&PhD
Phone
+46 33 616 1000
Email
per-ola.park@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per-Ola Park, MD&PhD
Organizational Affiliation
South Alvsborg Hospital, Boras, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, South Alvsborg Hospital
City
Boras
ZIP/Postal Code
50282
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per-Ola Park, MD&PhD
Phone
+46 33 616 10 00
Email
per-ola.park@vgregion.se
First Name & Middle Initial & Last Name & Degree
Per-Ola Park, MD&PhD
12. IPD Sharing Statement
Learn more about this trial
Transgastric Peritoneoscopy and Appendectomy
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