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

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

Study Locations

      • Boras, Sweden, 50282
        • Recruiting
        • Department of Surgery, South Alvsborg Hospital
        • Contact:
        • 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:
  • No more interventions

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.

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

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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