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Transgastric Peritoneoscopy and Appendectomy

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ClinicalTrials.gov Identifier: NCT00952146
Recruitment Status : Unknown
Verified August 2009 by Sodra Alvsborgs Hospital.
Recruitment status was:  Recruiting
First Posted : August 6, 2009
Last Update Posted : August 6, 2009
Sponsor:
Collaborator:
Borås Lasarett
Information provided by:
Sodra Alvsborgs Hospital

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.

Condition or disease Intervention/treatment Phase
Abdominal Pain Procedure: Transgastric peritoneoscopy (NOTES) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transgastric Diagnostic Peritoneoscopy (Laparoscopy) and Appendectomy - A Pilot Study
Study Start Date : November 2007
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. To test the feasibility of transgastric peritoneoscopy [ Time Frame: When discharged from hospital, 1 month post-op and one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): 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
Borås Lasarett
Investigators
Principal Investigator: Per-Ola Park, MD&PhD South Alvsborg Hospital, Boras, Sweden

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
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: August 6, 2009
Last Verified: August 2009

Keywords provided by Sodra Alvsborgs Hospital:
NOTES
Transgastric
Appendectomy
Safety
Feasibility

Additional relevant MeSH terms:
Abdominal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive