NCT00854815

Brief Summary

The purpose is to quantify the effect of irrigation during laparoscopic appendectomy for perforated appendicitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

December 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

3.5 years

First QC Date

March 2, 2009

Last Update Submit

July 31, 2012

Conditions

Perforated Appendicitis

Keywords

Perforated appendicitislaparoscopic appendectomychildrenirrigation

Outcome Measures

Primary Outcomes (1)

  • Post-operative abscess

    1 month

Secondary Outcomes (2)

  • operating time

    1 day

  • length of stay

    2 weeks

Study Arms (2)

Irrigation

ACTIVE COMPARATOR

Irrigation of the area with at least 500ml normal saline using the power suction/irrigator

Procedure: Irrigation

No Irrigation

ACTIVE COMPARATOR

Only suction with the power suction/irrigator without saline attached

Procedure: No Irrigation

Interventions

IrrigationPROCEDURE

Irrigation of the area with at least 500ml NS using the power suction/irrigator

Also known as: washout
Irrigation
No IrrigationPROCEDURE

Suction only using suction/irrigator

Also known as: suction
No Irrigation

Eligibility Criteria

Age1 Month - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Under 18 yrs old
  • Perforation identified as hole in the appendix or fecalith in the abdomen

You may not qualify if:

  • No perforation
  • A significant comorbidity that would limit their ability to recover from appendectomy in a normal fashion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Therapeutic IrrigationWASH protein, DrosophilaSuction

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative TechniquesDrainageSurgical Procedures, Operative

Study Officials

  • Shawn D St. Peter, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 3, 2009

Study Start

December 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(1)