Transgastric Peritoneoscopy and Appendectomy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Sodra Alvsborgs Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Sodra Alvsborgs Hospital
Collaborator:
Department of Surgery. SAS, Boras, Sweden
Information provided by:
Sodra Alvsborgs Hospital
ClinicalTrials.gov Identifier:
NCT00952146
First received: June 15, 2009
Last updated: August 4, 2009
Last verified: August 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Abdominal Pain |
Procedure: Transgastric peritoneoscopy (NOTES) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Transgastric Diagnostic Peritoneoscopy (Laparoscopy) and Appendectomy - A Pilot Study |
Resource links provided by NLM:
Further study details as provided by Sodra Alvsborgs Hospital:
Primary Outcome Measures:
- To test the feasibility of transgastric peritoneoscopy [ Time Frame: When discharged from hospital, 1 month post-op and one year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Transgastric peritoneoscopy
Only one arm, feasibility study
|
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.
Other Name: No more interventions
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952146
Contacts
| Contact: Per-Ola Park, MD&PhD | +46 33 616 1000 | per-ola.park@vgregion.se |
Locations
| Sweden | |
| Department of Surgery, South Alvsborg Hospital | Recruiting |
| Boras, Sweden, 50282 | |
| Contact: Per-Ola Park, MD&PhD +46 33 616 10 00 per-ola.park@vgregion.se | |
| Principal Investigator: Per-Ola Park, MD&PhD | |
Sponsors and Collaborators
Sodra Alvsborgs Hospital
Department of Surgery. SAS, Boras, Sweden
Investigators
| Principal Investigator: | Per-Ola Park, MD&PhD | South Alvsborg Hospital, Boras, Sweden |
More Information
No publications provided
| Responsible Party: | Per-Ola Park, Department of Surgery, South Alvsborg Hospital, Boras, Sweden |
| ClinicalTrials.gov Identifier: | NCT00952146 History of Changes |
| Other Study ID Numbers: | South Alvsborg Hospital |
| Study First Received: | June 15, 2009 |
| Last Updated: | August 4, 2009 |
| Health Authority: | Sweden: The National Board of Health and Welfare |
Keywords provided by Sodra Alvsborgs Hospital:
|
NOTES Transgastric Appendectomy Safety Feasibility |
Additional relevant MeSH terms:
|
Abdominal Pain Pain Signs and Symptoms Signs and Symptoms, Digestive |
ClinicalTrials.gov processed this record on May 22, 2013