- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00952146
Transgastric Peritoneoscopy and Appendectomy
August 4, 2009 updated by: Sodra Alvsborgs Hospital
Transgastric Diagnostic Peritoneoscopy (Laparoscopy) and Appendectomy - A Pilot Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Per-Ola Park, MD&PhD
- Phone Number: +46 33 616 1000
- Email: per-ola.park@vgregion.se
Study Locations
-
-
-
Boras, Sweden, 50282
- Recruiting
- Department of Surgery, South Alvsborg Hospital
-
Contact:
- Per-Ola Park, MD&PhD
- Phone Number: +46 33 616 10 00
- Email: per-ola.park@vgregion.se
-
Principal Investigator:
- Per-Ola Park, MD&PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transgastric peritoneoscopy
Only one arm, feasibility study
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To test the feasibility of transgastric peritoneoscopy
Time Frame: When discharged from hospital, 1 month post-op and one year
|
When discharged from hospital, 1 month post-op and one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Per-Ola Park, MD&PhD, South Alvsborg Hospital, Boras, Sweden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Anticipated)
December 1, 2010
Study Completion (Anticipated)
December 1, 2010
Study Registration Dates
First Submitted
June 15, 2009
First Submitted That Met QC Criteria
August 4, 2009
First Posted (Estimate)
August 6, 2009
Study Record Updates
Last Update Posted (Estimate)
August 6, 2009
Last Update Submitted That Met QC Criteria
August 4, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- South Alvsborg Hospital
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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