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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03267082
Other study ID # ERLMPA
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 20, 2017
Last updated August 27, 2017
Start date September 15, 2017
Est. completion date March 15, 2019

Study information

Verified date August 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A laparoscopic appendectomy (LA) was first reported by Semm in 1983. Since then, its advantages, such as the aesthetic appearance of the wound, less postoperative pain, and faster recovery which facilitates early discharge, have been highlighted, and the number of procedures performed has been continuously increasing.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date March 15, 2019
Est. primary completion date March 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Laparoscopic management of perforated appendicitis
Insertion of Ports Exposure of the Appendix peritoneal toilet and aspiration of pus after abdominal exposure Isolation of Mesoappendicular Artery Clipping and Dividing of the Artery Application of 3 x Endoloops Division of the Appendix Retrieval of the Appendix in an Endobag

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Frazee RC, Bohannon WT. Laparoscopic appendectomy for complicated appendicitis. Arch Surg. 1996 May;131(5):509-11; discussion 511-3. — View Citation

Semm K. Endoscopic appendectomy. Endoscopy. 1983 Mar;15(2):59-64. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary early recovery recovery within 2 days 2 day
Secondary wound cosmetic appearance no scare of incision post laporscopic mangement 6 months
See also
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Recruiting NCT00677989 - Study on Laparoscopic Operation for Perforated Appendicitis N/A
Terminated NCT00540189 - Initial Versus Delayed Operation for Treatment of Complicated Appendicitis In Children N/A
Completed NCT00677417 - Diagnostic Value of Hyperbilirubinaemia as a Predictive Factor for Appendiceal Perforation in Acute Appendicitis N/A
Terminated NCT03795194 - Antibiotic Duration in Post-appendectomy Abscess Phase 4
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Completed NCT02881996 - The Impact of IV Acetaminophen on Pain After Appendectomy for Perforated Appendicitis N/A
Active, not recruiting NCT04039750 - Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis Phase 2
Completed NCT02724410 - Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis N/A
Recruiting NCT04253899 - The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations N/A
Completed NCT00854815 - Irrigation Versus No Irrigation for Perforated Appendicitis N/A
Completed NCT00195923 - Prospective Randomized Evaluation of Antibiotic Regimen Following Appendectomy for Perforated Appendicitis Phase 4
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