Clinical Trial: Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children Aged 7-17 Years Old - Antibiotics Versus Primary Append

Brief Summary:

OBJECTIVE

The aim of this study is to compare the effectiveness of initial non-operative treatment strategy (reserving appendectomy for those not responding or with recurrent disease) with immediate appendectomy in children from 7 to 17 years old, inclusive, with acute simple appendicitis in terms of complications, health-related QOL and costs.

Main research question: What is the difference in proportion of patients experiencing complications within 1 year between both strategies in children from 7 to 17 years old, inclusive, with acute simple appendicitis?


Detailed Summary: Initial non-operative treatment of acute simple appendicitis has recently been investigated in both the adult as the paediatric population. In the adult population, six Randomised Controlled Trial (RCTs) showed that an appendectomy could be avoided in 40-76% of the patients at the end of their follow-up period. Despite the fact that some patients need to undergo a delayed appendectomy, it has been demonstrated in systematic reviews that non-operative treatment strategy is associated with a significant reduction in complications, faster recovery and return to work, less pain duration and analgesic medication consumption. In children only pilot data is yet available. Short-term success rates of this strategy (including of the investigators own pilot cohort study) are between the 83-92%. Long-term results (one-year follow-up) are available from two studies; 62-75% did not require an appendectomy. No large RCT have yet been conducted in the paediatric population. It is therefore essential to generate high quality empirical evidence regarding this strategy in this subset of patients.
Sponsor: Ramon Gorter

Current Primary Outcome: Proportion of patients experiencing complications [ Time Frame: One year follow up ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of days absent from school, social or sport events [ Time Frame: 7 days, 1,6,12 months ]
  • Number of days absent from work [ Time Frame: 7 days, 1,6,12 months ]
  • Total number of extra visits (not the already scheduled ones) to the outpatient clinic, general practitioners office or emergency department for abdominal pain. [ Time Frame: 7 days, 1,6,12 months ]
  • Total length of hospital stay during the follow-up period for strategy related treatment or complications [ Time Frame: 7 days, 1,6,12 months ]
  • Total days of analgesics medication use. [ Time Frame: one month ]
  • Pain score measured by the Visual Analogue Scale (VAS) [ Time Frame: Clinical phase (up to 7 days) ]
  • Proportion of patients with missed diagnosis of complex appendicitis with risk of peritonitis [ Time Frame: 7 days, 1,6,12 months ]
  • Proportion of patients not having to undergone appendectomy [ Time Frame: 7 days, 1,6,12 months ]
  • Proportion of patients experiencing recurrent appendicitis [ Time Frame: 7 days, 1,6,12 months ]
  • Proportion of patients experiencing early failure of initial non-operative treatment. [ Time Frame: 7 days, 1,6,12 months ]
  • Proportion of patients that undergo interval appendectomy. [ Time Frame: 7 days, 1,6,12 months ]
  • Quality of life questionnaire (CHQ-CF87, EQ-5d-Youth, EQ-5d-Proxy) [ Time Frame: 7 days, 1,6,12 months ]
  • Medical and non-medical costs (Health and Labor questionnaire) [ Time Frame: 1,6,12 months ]
  • Quality adjusted life years (QALY's). Calculating using outcome 13 and 14 [ Time Frame: 1,6,12 months ]
  • Patient satisfaction questionnaire (PSQ-18 & Net promotor score) [ Time Frame: 7 days, 1,6,12 months ]
  • Promoting and obstructing factors of implementability measured by questionnaires [ Time Frame: 12 months ]


Original Secondary Outcome:

  • Number of days absent from school, social or sport events [ Time Frame: 1,3,6,9,12 months ]
  • Number of days absent from work [ Time Frame: 1,3,6,9,12 months ]
  • Total number of extra visits (not the already scheduled ones) to the outpatient clinic, general practitioners office or emergency department for abdominal pain. [ Time Frame: 1,3,6,9,12 months ]
  • Total length of hospital stay during the follow-up period for strategy related treatment or complications [ Time Frame: 1,3,6,9,12 months ]
  • Total days of analgesics medication use. [ Time Frame: one month ]
  • Pain score measured by the Visual Analogue Scale (VAS) [ Time Frame: Clinical phase (up to 7 days) ]
  • Proportion of patients with missed diagnosis of complex appendicitis with risk of peritonitis [ Time Frame: 1,3,6,9,12 months ]
  • Proportion of patients not having to undergone appendectomy [ Time Frame: 1,3,6,9,12 months ]
  • Proportion of patients experiencing recurrent appendicitis [ Time Frame: 1,3,6,9,12 months ]
  • Proportion of patients experiencing early failure of initial non-operative treatment. [ Time Frame: 1,3,6,9,12 months ]
  • Proportion of patients that undergo interval appendectomy. [ Time Frame: 1,3,6,9,12 months ]
  • Quality of life questionnaire (CHQ-CF87, EQ-5d-Youth, EQ-5d-Proxy) [ Time Frame: 1,3,6,9,12 months ]
  • Medical and non-medical costs (Health and Labor questionnaire) [ Time Frame: 1,3,6,9,12 months ]
  • Quality adjusted life years (QALY's). Calculating using outcome 13 and 14 [ Time Frame: 1,3,6,9,12 months ]
  • Patient satisfaction questionnaire (PSQ-18 & Net promotor score) [ Time Frame: 1,3,6,9,12 months ]
  • Promoting and obstructing factors of implementability measured by questionnaires [ Time Frame: 1,3,6,9,12 months ]


Information By: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Dates:
Date Received: July 24, 2016
Date Started: December 2016
Date Completion: December 2020
Last Updated: December 21, 2016
Last Verified: December 2016