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
Sponsor:
Collaborator:
Borås Lasarett
Information provided by:
Sodra Alvsborgs Hospital
ClinicalTrials.gov Identifier:
NCT00952146
First received: June 15, 2009
Last updated: August 4, 2009
Last verified: August 2009
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Borås Lasarett
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 July 29, 2014