Feasability of Ambulatory Appendicectomy

NCT03186105 | Completed

• 1 other identifier: 16-HPNCL-05
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a monocentric prospective preliminary study evaluating the feasibility of appendectomy for simple acute appendicitis in a cohort of 6-17 year-old children presenting to the emergency department of the Hôpital Pédiatrique de Nice CHU-Lenval (Lenval Childre Hospital, Nice) on a Period of 1 year.

Conditions

Appendicitis Acute

Keywords

Appendicitis Acute; AMBULATORY

Outcome Measures

Primary Outcomes (1)

• Feasibility of ambulatory care

  Feasibility is defined as the association of the return to the patient's home within the twelve hours of the intervention and the absence of re-hospitalization or recourse to town medicine before the postoperative consultation at day 8

  day 8 after intervention

Secondary Outcomes (10)

• pain of the patient at home

  3 post-operative days

• rate of patients able to return home on the day of the intervention

  the day of the intervention at day 0

• rate of consultations at Emergencies unit care before 8 days post operative

  8 days post operative

• Parent Satisfaction

  8 days post operative

• Patient Satisfaction

  8 days post operative

Study Arms (1)

Ambulatory appendicectomy

EXPERIMENTAL

The intervention consist of an ambulatory care by appendicectomy of the acute appendicitis. The normal care is an appendicectomy and an hospitalisation during 2 or 3 days.

Other: Ambulatory appendicectomy

Interventions

Ambulatory appendicectomy OTHER

The intervention consist of an ambulatory care by appendicectomy of the acute appendicitis. The normal care is an appendicectomy and an hospitalisation during 2 or 3 days .

Ambulatory appendicectomy

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Boy or girl
• Subjects aged 6 to 17 years (Children under 6 years of age with a table of acute appendicitis will not be included in the high probability of complicated acute appendicitis in these young children who are often rapidly changing pathology or delayed diagnosis Patients over 17 years of age are usually referred to adult hospitals and will not be included)
• Surgical indication of appendectomy under laparoscopy for simple acute appendicitis according to clinico-biological criteria (Appendix 6).
• Ambulatory eligibility according to the criteria usually defined
• Parents and children able to understand the study and having signed informed consent
• Possibility of organizing childcare immediately at home
• Subjects and holders of parental authority who have given their informed and written consent
• Subjects affiliated to Social Security system

You may not qualify if:

• Patients who had spent an overnight stay in hospital prior to surgery and therefore could not meet the ambulatory criteria.
• An ASA score higher than III
• Impossibility of ambulatory surgery due to a residence outside the coverage area defined by the surgical and ambulatory anesthesia service, the impossibility of being transported after returning home, the absence of parents Child after discharge from hospital
• Contra-indication to the practice of an appendectomy under laparoscopy

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Hôpitaux Pédiatriques de Nice CHU-LENVAL

Nice, 06200, France

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Florence BASTIANI, MD

  Hôpitaux Pédiatriques de Nice CHU-LENVAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 14, 2017
• Study Start: June 1, 2017
• Primary Completion: June 2, 2019
• Study Completion: June 2, 2019
• Last Updated: July 22, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)