NCT00135603

Brief Summary

The purpose of the study is to demonstrate that antibiotic therapy is as safe and effective as appendectomy for the treatment of acute non complicated appendicitis. Two hundred fifty patients will be included in a prospective multicentric randomized trial. The primary endpoint is the rate of intra abdominal infections in both therapeutic strategies. Other criteria will be studied including duration of hospital stay and absence from work during a follow up period of one year, parietal and abdominal complications and recurrent appendicitis after antibiotic therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
243

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

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

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 12, 2009

Status Verified

January 1, 2009

Enrollment Period

4 years

First QC Date

August 24, 2005

Last Update Submit

February 11, 2009

Conditions

Appendicitis

Keywords

appendicitis.adult.treatment.antibiotic therapy.CT scanning.randomized trialsafety

Outcome Measures

Primary Outcomes (1)

  • rate of intra abdominal infections in both therapeutic strategies

    30 days

Secondary Outcomes (8)

  • duration of pain

    30 days

  • duration of hospitalisation

    30 days

  • duration of absence from work

    30 days

  • rate of wound infection

    30 days

  • recurrence of appendicitis

    12 months

  • +3 more secondary outcomes

Study Arms (2)

A

ACTIVE COMPARATOR

appendectomy, actual usual treatment

Procedure: appendectomy

B

ACTIVE COMPARATOR

antibiotic therapy

Drug: amoxicillin/clavulanate potassium

Interventions

amoxicillin/clavulanate potassiumDRUG

1 gramme, 3 times a day, intra venous initially and then orally for one or two weeks

B
appendectomyPROCEDURE

ablation of the appendix by laparotomy or laparoscopy

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical suspicion of appendicitis
  • Age more than 18 years

You may not qualify if:

  • Clinical signs of generalized peritonitis
  • Previous take of antibiotics within the 5 days preceding the presentation
  • Allergy or intolerance to lactamases and/or clavulanate potassium
  • Corticosteroid or anticoagulant therapy
  • Patient with a known inflammatory bowel disease (Crohn's disease or ulcerative colitis)
  • Pregnant women
  • Patient with iode allergy
  • Renal insufficiency (creatinine \> 200 )
  • CT scanning:
  • Appendix diameter \> 6 mm
  • Appendix non visualised
  • Signs of localized peritonitis:
  • extradigestive gas
  • fluid collection around the appendix
  • generalized intraperitoneal fluid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Antoine Béclère Hospital - Department of Surgery

Clamart, 92141 cedex, France

Location

Henri Mondor Hospital

Créteil, 94, France

Location

Hotel Dieu Hospital, Department of Digestive Surgery

Paris, 75004, France

Location

Cochin Hospital, Department of Digestive Surgery

Paris, 75014, France

Location

Lariboisière Hospital, Department of Digestive Surgery

Paris, 75475, France

Location

Related Publications (1)

  • Vons C, Barry C, Maitre S, Pautrat K, Leconte M, Costaglioli B, Karoui M, Alves A, Dousset B, Valleur P, Falissard B, Franco D. Amoxicillin plus clavulanic acid versus appendicectomy for treatment of acute uncomplicated appendicitis: an open-label, non-inferiority, randomised controlled trial. Lancet. 2011 May 7;377(9777):1573-9. doi: 10.1016/S0140-6736(11)60410-8.

    PMID: 21550483DERIVED

MeSH Terms

Conditions

Appendicitis

Interventions

Amoxicillin-Potassium Clavulanate CombinationAppendectomy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Corinne Vons, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2005

First Posted

August 26, 2005

Study Start

February 1, 2004

Primary Completion

February 1, 2008

Study Completion

December 1, 2008

Last Updated

February 12, 2009

Record last verified: 2009-01

Locations

FR(5)