NCT00952146

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

3.1 years

First QC Date

June 15, 2009

Last Update Submit

August 4, 2009

Conditions

Abdominal Pain

Keywords

NOTESTransgastricAppendectomySafetyFeasibility

Outcome Measures

Primary Outcomes (1)

  • To test the feasibility of transgastric peritoneoscopy

    When discharged from hospital, 1 month post-op and one year

Study Arms (1)

Transgastric peritoneoscopy

EXPERIMENTAL

Only one arm, feasibility study

Procedure: Transgastric peritoneoscopy (NOTES)

Interventions

Transgastric peritoneoscopy (NOTES)PROCEDURE

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.

Also known as: No more interventions
Transgastric peritoneoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with acute abdominal pain

You may not qualify if:

  • Patient under 18
  • Patient who cannot understand information in Swedish
  • Patients previously operated in upper part of the abdomen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, South Alvsborg Hospital

Borås, 50282, Sweden

RECRUITING

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Per-Ola Park, MD&PhD

    South Alvsborg Hospital, Boras, Sweden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Per-Ola Park, MD&PhD

CONTACT

+46 33 616 1000per-ola.park@vgregion.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2009

First Posted

August 6, 2009

Study Start

November 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 6, 2009

Record last verified: 2009-08

Locations

SE(1)