Antibiotic Therapy vs Laparscopic Appendectomy in Pediatric Chronic Appendicitis

Chronic Appendicitis Clinical Trial

— ATvsLAAPT  

Official title:

Mutil-institutions Comparing Antibiotic Therapy With Laparscopic Appendectomy in Pediatric Chronic Appendicitis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03754387
• Other study ID #: ZunyiMU
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: November 2018
• Source: Zunyi Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

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)

Related Conditions & MeSH terms

• Appendicitis
• Chronic Appendicitis

Intervention

Drug:
• Ceftazidime
Patients choosing AT group were admitted to the hospital for observation and to receive intravenous antibiotics Intravenous Ceftazidime sodium (50mg/kg/dose every 12 hours) was administered for 3 days.

Procedure:
• appendectomy
APPT group consisted of admission to the hospital with promptinitiation of intravenous antibiotics and appendectomy

Locations

Country	Name	City	State
China	children's hospital of Guiyang	Guiyang	Guizhou
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou
China	The first people hospital of zunyi	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Zunyi Medical College

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View Citation

Salminen P, Paajanen H, Rautio T, Nordström P, Aarnio M, Rantanen T, Tuominen R, Hurme S, Virtanen J, Mecklin JP, Sand J, Jartti A, Rinta-Kiikka I, Grönroos 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate	The primary end point for patients in the antibiotic therapy group is resolution of chronic appendicitis, resulting in discharge from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of 1 year (treatment efficacy). Treatment success in the laparoscopic appendectomy group is defined as a patient successfully undergoing an laparoscopic appendectomy and no recurrent abdominal pain during a minimum follow-up of 1 year (treatment efficacy).	1 year
Secondary	The rate of recurrence	late recurrence (after 1 year) of chronic appendicitis after conservative treatment, length of hospital stay and the amount of sick leave used by the patient.	1 year
Secondary	postintervention pain scores	postintervention pain scores (VAS score range, 0-10; a score of 0 indicates no pain and 10 indicates the worst possible pain), and the use of pain medication.	1 year
Secondary	Wound infection	Postintervention complications included clinical wound infection (surgical site infection) occurring within 30 days after the operative procedure as diagnosed by a surgeon or with a positive bacterial culture.	30 days
Secondary	pneumonia	Postintervention complication included pneumonia occurring within 7days after the operative procedure as diagnosed by clinical presentation and chest X-ray or CT-scan.	7days
Secondary	Diarrhea	Adverse effects of the antibiotic treatment during the conservation treatment	7 days
Secondary	Incisional hernia	Postintervention complication included incisional hernia occurring within1year after the operative procedure as diagnosed by surgeon .	1 year
Secondary	Bowel obstruction	Postintervention complication included bowel obstruction occurring within1year after the operative procedure as diagnosed by clinical presentation and abdominal X-ray or CT-scan.	1 year
Secondary	persistent abdominal or incisional pain	Postintervention complication included persistent abdominal or incisional pain occurring within1year after the operative procedure as diagnosed by surgeon .	1 year