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Conservative Treatment of Acute Appendicitis in Children (CONSAPP Pilot)

Primary Purpose

Appendicitis, Child

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Appendectomy
Conservative, non-surgical treatment
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis focused on measuring Appendectomy, Nonsurgical treatment with antibiotics

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children 5-15 years old with a clinical diagnosis of appendicitis that prior to the trial would have been subjected to a surgical intervention

Exclusion Criteria:

  • Suspicion of perforated appendicitis on the basis of generalized peritonitis
  • An appendiceal mass, diagnosed either by palpation or with radiology

Sites / Locations

  • Astrid Lindgren Children´s Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Appendectomy

Conservative, non-surgical treatment

Arm Description

Standard surgical treatment, appendectomy

Non-operative treatment with intravenous and oral antibiotics

Outcomes

Primary Outcome Measures

Resolution of symptoms without significant complications
This outcome measure is designed to be similar between the two groups. It is measured in number of participants that fails its designated treatment. Failure of treatment include abscess formation requiring treatment (prolonged antibiotic course or drainage), wound infection requiring intravenous antibiotics, wound dehiscence requiring treatment, prolonged ileus >5 days, length of stay >7 days, recurrent appendicitis, persistance of symptoms leading to surgery and negative appendectomy.

Secondary Outcome Measures

Time in hospital
Number of days as inpatients after initiation of allocated treatment, ea. after randomization.
Time to resolution of symptoms
In hours, to the time where there is no significant pain (VAS not more than 3), no temprature nor any anorexia.
Abscess formation
As noted either in hospital or during follow up.
Early complications
Wound infections, wound dehiscence, diarrhea etc.
Pain
Measured after 12, 24 and 48 hours with the 0-10 Visual Analoge Scale.

Full Information

First Posted
February 13, 2012
Last Updated
October 15, 2012
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01572558
Brief Title
Conservative Treatment of Acute Appendicitis in Children
Acronym
CONSAPP Pilot
Official Title
Conservative Treatment of Acute Appendicitis in Children Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a feasibility study that will be performed at the Astrid Lindgren Children´s Hospital, Karolinska University Hospital, Stockholm, Sweden. It will involve 50 patients, randomized to either conservative, non-operative, treatment with antibiotics OR surgery. The study will test an computerized randomization system, the availability of patients willing to participate in the trial and the trial protocol. The investigators will assess the characteristics of the patients who agree to participate in the study and those who do not. The investigators will explore short term outcome and design suitable long term outcome measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis, Child
Keywords
Appendectomy, Nonsurgical treatment with antibiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Appendectomy
Arm Type
Active Comparator
Arm Description
Standard surgical treatment, appendectomy
Arm Title
Conservative, non-surgical treatment
Arm Type
Experimental
Arm Description
Non-operative treatment with intravenous and oral antibiotics
Intervention Type
Procedure
Intervention Name(s)
Appendectomy
Other Intervention Name(s)
Open appendectomy, Laparoscopic appendectomy
Intervention Description
Standard surgical treatment, normally laparoscopic appendectomy
Intervention Type
Drug
Intervention Name(s)
Conservative, non-surgical treatment
Other Intervention Name(s)
Meronem®, Meropenem, Flagyl®, Metronidazol, Ciproxin®, Ciprofloxacin
Intervention Description
Non-surgical treatment, intravenous and oral antibiotics. Meropenem and Metronidazol will be used as intravenous antibiotics, Ciprofloxacin and Metronidazol will be used as oral antibiotics.
Primary Outcome Measure Information:
Title
Resolution of symptoms without significant complications
Description
This outcome measure is designed to be similar between the two groups. It is measured in number of participants that fails its designated treatment. Failure of treatment include abscess formation requiring treatment (prolonged antibiotic course or drainage), wound infection requiring intravenous antibiotics, wound dehiscence requiring treatment, prolonged ileus >5 days, length of stay >7 days, recurrent appendicitis, persistance of symptoms leading to surgery and negative appendectomy.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Time in hospital
Description
Number of days as inpatients after initiation of allocated treatment, ea. after randomization.
Time Frame
7 days
Title
Time to resolution of symptoms
Description
In hours, to the time where there is no significant pain (VAS not more than 3), no temprature nor any anorexia.
Time Frame
7 days
Title
Abscess formation
Description
As noted either in hospital or during follow up.
Time Frame
7 days
Title
Early complications
Description
Wound infections, wound dehiscence, diarrhea etc.
Time Frame
7 days
Title
Pain
Description
Measured after 12, 24 and 48 hours with the 0-10 Visual Analoge Scale.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children 5-15 years old with a clinical diagnosis of appendicitis that prior to the trial would have been subjected to a surgical intervention Exclusion Criteria: Suspicion of perforated appendicitis on the basis of generalized peritonitis An appendiceal mass, diagnosed either by palpation or with radiology
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan F Svensson, MD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Astrid Lindgren Children´s Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
31800496
Citation
Patkova B, Svenningsson A, Almstrom M, Eaton S, Wester T, Svensson JF. Nonoperative Treatment Versus Appendectomy for Acute Nonperforated Appendicitis in Children: Five-year Follow Up of a Randomized Controlled Pilot Trial. Ann Surg. 2020 Jun;271(6):1030-1035. doi: 10.1097/SLA.0000000000003646.
Results Reference
derived
PubMed Identifier
25072441
Citation
Svensson JF, Patkova B, Almstrom M, Naji H, Hall NJ, Eaton S, Pierro A, Wester T. Nonoperative treatment with antibiotics versus surgery for acute nonperforated appendicitis in children: a pilot randomized controlled trial. Ann Surg. 2015 Jan;261(1):67-71. doi: 10.1097/SLA.0000000000000835.
Results Reference
derived

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Conservative Treatment of Acute Appendicitis in Children

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