Clinical Trial: Multi-institutional Trial of Non-operative Management of Appendicitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Multi-institutional Trial of Non-operative Management of Uncomplicated Pediatric Appendicitis

Brief Summary: A successful non-operative management strategy for early appendicitis will decrease the number of children requiring surgery and may improve the quality of care related to the treatment of appendicitis. To account for the child-family perspective and treatment preferences, the investigators will perform a study in which patients and their families choose between antibiotics alone (Non-operative group) or appendectomy (Surgery group) at ten U.S. hospitals. This study will determine the effectiveness of non-operative management of early appendicitis with antibiotics alone in children and compare differences in morbidity, disability, quality of life, satisfaction, and cost between families choosing surgery or non-operative management.

Detailed Summary: Several randomized controlled trials comparing appendectomy to antibiotics alone in adults with acute appendicitis have been reported from non-U.S. countries. These studies reveal that non-operative management of appendicitis is a safe treatment for appendicitis and is associated with a significantly lower risk of complications than appendectomy. We have recently completed the first study in the U.S. examining the feasibility of non-operative management of uncomplicated appendicitis in children. In our pilot study, patients and their families chose between urgent appendectomy or antibiotics alone for treatment of uncomplicated appendicitis. The success rate of non-operative management was 90% at 30 days and 80% at a median follow-up of 8 months. In addition, patients in the non-operative group demonstrated a significantly faster return to normal activity and reported higher quality of life scores. The current proposal seeks to further investigate the effectiveness of non-operative management with antibiotics alone as a treatment option for children with uncomplicated appendicitis. When randomized trials are not feasible due to strong treatment preferences or when only a small proportion of patients will accept randomization, a parallel group non-randomized study where participants are allocated to their preferred treatment is a valuable alternative. Based on feedback from a multi-disciplinary stakeholder group that was convened to assess the potential impact of family preferences on study outcomes, recruitment, and generalizability, we propose a multi-institutional trial in which patients and their families choose between antibiotics alone (Non-operative group) or appendectomy (Surgery group). We hypothesize that non-operative management will be successful in 75% of patients at 1 year follow-up and will be associated with fewer disability days, higher quality of life scores, and lower costs than appendectomy. This study will enroll 795 patients, age 8-17 years, with
Sponsor: Nationwide Children's Hospital

Current Primary Outcome:

• Success rate [ Time Frame: 1 year ]
  success rate at 1 year is percent of patients choosing non-operative management who have not undergone an appendectomy
• Disability Days [ Time Frame: 1 year ]
  Number of days without normal schedule

Original Primary Outcome: Success rate [ Time Frame: 1 year ]

Current Secondary Outcome: Perforated appendicitis [ Time Frame: 1 year ]

Original Secondary Outcome:

• Disability Days [ Time Frame: 1 year ]
  Number of days without normal schedule
• Perforated appendicitis [ Time Frame: 1 year ]
  percent of patients with perforated appendicitis at operation

Information By: Nationwide Children's Hospital

Dates:
Date Received: October 20, 2014
Date Started: October 2014
Date Completion: January 2020
Last Updated: August 18, 2016
Last Verified: August 2016