- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03267082
Evaluation the Role of Laparoscopic Management of Perforated Appendicitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The LA was performed mostly on uncomplicated appendicitis due to negative opinions about its safety when it was first introduced. However, the application of the procedure has been extended to complicated appendicitis (CA), and it is now considered as an alternative procedure to an open appendectomy (OA) as its safety record has improved . Nevertheless, it is still controversial because there are still concerns about surgical difficulties in managing CA with laparoscopy, overall surgery time, possible post-op complications and conversion to an OA during the surgery.
this study aimed to evaluate the safety and the efficacy of LA for managing perforated appendicitis.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of acute perforated appendicitis
- fit for laparoscopy and general anesthesia.
- written informed consent.
- short term outcome data and agree to provide contact information.
Exclusion Criteria:
- high risk for general anesthesia.
- Appendicular abscess and appendicular mass .
- ongoing infections including chest infections .
- Children and pregnant females .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Evaluation the role of Laparoscopic management of perforated a
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
early recovery
Time Frame: 2 day
|
recovery within 2 days
|
2 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
wound cosmetic appearance
Time Frame: 6 months
|
no scare of incision post laporscopic mangement
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERLMPA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Perforated Appendicitis
-
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