NCT01515293

Brief Summary

The aim of this study is to compare the short-term outcomes of single-incision and conventional laparoscopic appendectomy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P25-P50 for phase_3

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

September 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
Last Updated

January 24, 2012

Status Verified

May 1, 2011

Enrollment Period

1.2 years

First QC Date

January 18, 2012

Last Update Submit

January 23, 2012

Conditions

Appendicitis

Study Arms (2)

Single Incision Laparoscopic Appendectomy

EXPERIMENTAL
Procedure: Single Incision Laparoscopic Appendectomy

Conventional appendectomy

EXPERIMENTAL

Conventional appendectomy

Procedure: Conventional appendectomy

Interventions

Single Incision Laparoscopic AppendectomyPROCEDURE
Single Incision Laparoscopic Appendectomy
Conventional appendectomyPROCEDURE
Conventional appendectomy

Eligibility Criteria

Age12 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with suspected acute appendicitis

You may not qualify if:

  • Perforated appendicitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Frutos MD, Abrisqueta J, Lujan J, Abellan I, Parrilla P. Randomized prospective study to compare laparoscopic appendectomy versus umbilical single-incision appendectomy. Ann Surg. 2013 Mar;257(3):413-8. doi: 10.1097/SLA.0b013e318278d225.

    PMID: 23386239DERIVED

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dolores Frutos HUV Arrixaca

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 24, 2012

Study Start

September 1, 2009

Primary Completion

December 1, 2010

Last Updated

January 24, 2012

Record last verified: 2011-05