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NCT00952146 Clinical Trial

Transgastric Peritoneoscopy and Appendectomy

Abdominal Pain Clinical Trial

Official title:
Transgastric Diagnostic Peritoneoscopy (Laparoscopy) and Appendectomy - A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00952146
Other study ID # South Alvsborg Hospital
Secondary ID
Status Recruiting
Phase N/A
First received June 15, 2009
Last updated August 4, 2009
Start date November 2007
Est. completion date December 2010

Study information
Verified date August 2009
Source Sodra Alvsborgs Hospital
Contact Per-Ola Park, MD&PhD
Phone +46 33 616 1000
Email per-ola.park@vgregion.se
Is FDA regulated No
Health authority Sweden: The National Board of Health and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• Transgastric peritoneoscopy (NOTES)
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.

Locations
Country Name City State
Sweden Department of Surgery, South Alvsborg Hospital Boras

Sponsors (2)
Lead Sponsor Collaborator
Sodra Alvsborgs Hospital Borås Lasarett

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary To test the feasibility of transgastric peritoneoscopy When discharged from hospital, 1 month post-op and one year Yes
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