Clinical trial NCT03754387: Antibiotic Therapy vs Laparscopic Appendectomy in Pediatric Chronic Appendicitis
Official title: Mutil-institutions Comparing Antibiotic Therapy With Laparscopic Appendectomy in Pediatric Chronic Appendicitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Appendicitis
Keywords: children
antibiotic therapy
laparoscopic appendectomy
randomized clinical trial(RCT)
Chronic appendicitis
Lead sponsor: Zunyi Medical College
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial will compare antibiotic therapy with laparoscopic appendectomy in the treatment of pediatric chronic appendicitis in china. Enrolled patients will be randomised and an allocation ratio of 1:1 will be made via weighted minimisation, where half of the patients will receive antibiotic therapy with intravenous Ceftazidime sodium, while the other half will have a laparoscopic appendicectomy.

Detailed description: In recent years, nonoperative treatment has challenged appendectomy as a first-line treatment of acute uncomplicated appendicitis by demonstrating its safety and short-term efficacy in adults. Several randomized controlled trials comparing appendectomy to antibiotics alone in children with acute uncomplicated appendicitis have been reported from other 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. However, the success rate of nonoperative management was 75% at 1year. Chronic appendicitis has been described as a possible cause of persistent right lower quadrant (RLQ) pain and laparoscopic appendectomy has been shown to benefit a large number of children，but there are no high-quality clinical trials. There are more than 200 million children in China. According to preliminary clinical data, the incidence of pediatric appendicitis in China is higher than Europe and America. Due to the Chinese parents have different cultures and educational backgrounds, more high-quality clinical trials are needed to guide parents to choose appropriate treatment for chronic appendicitis in children. Therefore, the investigators propose a multi-institutional trial in which patients and their families choose between antibiotics therapy (AT group) or laparoscopic appendectomy (LAAPT group) to chronic appendicitis in children aged 3-15 years. The investigators hypothesize that laparoscopic appendectomy will be successful in 90% of patients at 1 year follow-up and will be associated with fewer disability days, higher quality of life scores, and higher pain reduce scores than antibiotic therapy. This study will enroll 200 patients, age 3-15 years, with chronic appendicitis at 8-10 hospitals.

Eligibility criteria: Inclusion Criteria:

1. Patients were eligible if they were between 3 and 15 years of age, and they suffered from chronic appendicitis.
2. US showing hyperemia and fecalith, ≤ 1.1 cm in diameter, compressible or non-compressible, no abscess, no phlegmon or CT showing hyperemia and fecalith, fat stranding, ≤ 1.1 cm in diameter, no abscess, no phlegmon.

Exclusion Criteria:

1. Exclusion criteria consisted of (a history of) chronic back pain
2. previous abdominal surgery (with the exception of diagnostic laparoscopies or a laparoscopic sterilization)
3. specific gastro-intestinal entities (such as inflammatory bowel disease) 4.gynaecological disease (all female patients consulted a gynaecologist)

Primary outcomes:
measure: Success rate
timeFrame: 1 year
Secondary outcomes:
measure: The rate of recurrence
timeFrame: 1 year
measure: postintervention pain scores
timeFrame: 1 year
measure: Wound infection
timeFrame: 30 days
measure: pneumonia
timeFrame: 7days
measure: Diarrhea
timeFrame: 7 days
measure: Incisional hernia
timeFrame: 1 year
measure: Bowel obstruction
timeFrame: 1 year
measure: persistent abdominal or incisional pain
timeFrame: 1 year
Other outcomes:
Locations:
city: Guiyang
country: China
facility: children's hospital of Guiyang
state: Guizhou
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Zunyi
country: China
facility: The first people hospital of zunyi
state: Guizhou
Study officials:
affiliation: Zunyi Medical College
name: yuanmei Liu
role: STUDY_CHAIR
affiliation: Children's hospital of guiyang
name: peihong Yan, MD
role: STUDY_DIRECTOR
affiliation: Zunyi First People's Hospital
name: Shengli Gu, MD
role: STUDY_DIRECTOR
affiliation: Affiliated hospital of Binzhou
name: Lei Geng, MD
role: STUDY_DIRECTOR
affiliation: Children's hospital of Dalian
name: Ziyong Li, MD
role: STUDY_DIRECTOR
affiliation: People's Hospital of Anshun City of Guizhou Province
name: Guoqing He, MD
role: STUDY_DIRECTOR
affiliation: Medical university of Guizhou
name: Xuanzao Wu, MD
role: STUDY_DIRECTOR
affiliation: people hospital of Suiyang
name: Guohong Yang
role: STUDY_DIRECTOR
References:
citation: Minneci PC, Mahida JB, Lodwick DL, Sulkowski JP, Nacion KM, Cooper JN, Ambeba EJ, Moss RL, Deans KJ. Effectiveness of Patient Choice in Nonoperative vs Surgical Management of Pediatric Uncomplicated Acute Appendicitis. JAMA Surg. 2016 May 1;151(5):408-15. doi: 10.1001/jamasurg.2015.4534.
citation: Anderson KT, Bartz-Kurycki M, Austin MT, Kawaguchi A, John SD, Kao LS, Tsao K. Approaching zero: Implications of a computed tomography reduction program for pediatric appendicitis evaluation. J Pediatr Surg. 2017 Dec;52(12):1909-1915. doi: 10.1016/j.jpedsurg.2017.08.050. Epub 2017 Sep 5.
citation: Salminen P, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Tuominen R, Hurme S, Virtanen J, Mecklin JP, Sand J, Jartti A, Rinta-Kiikka I, Gronroos JM. Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPAC Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2340-8. doi: 10.1001/jama.2015.6154.