NCT02867072

Brief Summary

Appendectomy is the most common surgical procedure performed in emergency surgery. Because of lack of consensus about the most appropriate technique, appendectomy is still being performed by both open (OA) and laparoscopic (LA) methods. In this retrospective analysis, the investigators aimed to compare the laparoscopic approach and the conventional technique in the treatment of acute appendicitis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
593

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4

Status
completed

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

January 1, 2004

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

7.5 years

First QC Date

August 8, 2016

Last Update Submit

August 13, 2016

Conditions

Acute Appendicitis

Outcome Measures

Primary Outcomes (2)

  • Hospital cost

    Mean hospital cost (in Euro) for patients that underwent appendectomy

    3 days

  • Wound infection

    Number of patients with wound infection after appendectomy

    1 week

Study Arms (2)

Open appendectomy

ACTIVE COMPARATOR

Subjects that underwent open surgery for appendicitis

Procedure: Open appendectomy

Laparoscopic appendectomy

ACTIVE COMPARATOR

Subjects that underwent laparoscopic surgery for appendicitis

Procedure: Laparoscopic appendectomy

Interventions

Open appendectomyPROCEDURE
Open appendectomy
Laparoscopic appendectomyPROCEDURE
Laparoscopic appendectomy

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • acute appendicitis

You may not qualify if:

  • Pregnant women and patients with severe medical disease (hemodynamic instability, chronic medical or psychiatric illness, cirrhosis, coagulation disorders) requiring intensive care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Biondi A, Di Stefano C, Ferrara F, Bellia A, Vacante M, Piazza L. Laparoscopic versus open appendectomy: a retrospective cohort study assessing outcomes and cost-effectiveness. World J Emerg Surg. 2016 Aug 30;11(1):44. doi: 10.1186/s13017-016-0102-5. eCollection 2016.

    PMID: 27582784DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 15, 2016

Study Start

January 1, 2004

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 16, 2016

Record last verified: 2016-08