NCT03267082

Brief 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.

Trial Health

35
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 Sep 2017

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

First Submitted

Initial submission to the registry

August 20, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

1.5 years

First QC Date

August 20, 2017

Last Update Submit

August 27, 2017

Conditions

Perforated Appendicitis

Outcome Measures

Primary Outcomes (1)

  • early recovery

    recovery within 2 days

    2 day

Secondary Outcomes (1)

  • wound cosmetic appearance

    6 months

Study Arms (1)

Evaluation the role of Laparoscopic management of perforated a

EXPERIMENTAL
Other: Laparoscopic management of perforated appendicitis

Interventions

Laparoscopic management of perforated appendicitisOTHER

1. Insertion of Ports 2. Exposure of the Appendix 3. peritoneal toilet and aspiration of pus after abdominal exposure 4. Isolation of Mesoappendicular Artery 5. Clipping and Dividing of the Artery 6. Application of 3 x Endoloops 7. Division of the Appendix 8. Retrieval of the Appendix in an Endobag

Evaluation the role of Laparoscopic management of perforated a

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • high risk for general anesthesia.
  • Appendicular abscess and appendicular mass .
  • ongoing infections including chest infections .
  • Children and pregnant females .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Semm K. Endoscopic appendectomy. Endoscopy. 1983 Mar;15(2):59-64. doi: 10.1055/s-2007-1021466.

    PMID: 6221925RESULT

  • Frazee RC, Bohannon WT. Laparoscopic appendectomy for complicated appendicitis. Arch Surg. 1996 May;131(5):509-11; discussion 511-3. doi: 10.1001/archsurg.1996.01430170055010.

    PMID: 8624197RESULT

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
general surgery

Study Record Dates

First Submitted

August 20, 2017

First Posted

August 30, 2017

Study Start

September 15, 2017

Primary Completion

March 15, 2019

Study Completion

March 15, 2019

Last Updated

August 30, 2017

Record last verified: 2017-08