Antibiotic Therapy vs Laparscopic Appendectomy in Pediatric Chronic Appendicitis

NCT03754387 | Unknown

• 1 other identifier: ZunyiMU
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Appendicitis

Keywords

children; antibiotic therapy; laparoscopic appendectomy; randomized clinical trial(RCT); Chronic appendicitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The rate of recurrence

  1 year

• postintervention pain scores

  1 year

• Wound infection

  30 days

• pneumonia

  7days

• Diarrhea

  7 days

Study Arms (2)

Antibiotic therapy group

ACTIVE COMPARATOR

Ceftazidime will chosen as the antibiotic for this study because of its efficacy as a monotherapy for serious intraabdominal infections, requiring only a single, daily dose. Intravenous Ceftazidime sodium (50mg/kg/dose every 12 hours) is administered for 3 days to patients in the AT group, with the first dose given in the emergency department. The clinical status of patients in the AT group is reevaluated within 12 to 24 hours after admission by the surgeon on call. If the surgeon suspected progressive infection, perforated appendicitis, or peritonitis, the patient will underwent appendectomy. Intravenous antibiotic treatment will followed by 7 days of oral cefuroxime (250mg twice daily).

Drug: Ceftazidime

Laparoscopic Appendectomy group

EXPERIMENTAL

Laparoscopic appendectomy will performed using. Prophylactic antibiotics (ceftazidime sodium 50mg/kg/dose ) will administered approximately 30 minutes before the incision was made. No further antibiotics will given to patients in the surgical group unless a wound infection was suspected postoperatively.

Procedure: appendectomy

Interventions

Ceftazidime DRUG

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.

Antibiotic therapy group

appendectomy PROCEDURE

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

Laparoscopic Appendectomy group

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients were eligible if they were between 3 and 15 years of age, and they suffered from chronic appendicitis.
• 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.

You may not qualify if:

• previous abdominal surgery (with the exception of diagnostic laparoscopies or a laparoscopic sterilization)
• specific gastro-intestinal entities (such as inflammatory bowel disease) 4.gynaecological disease (all female patients consulted a gynaecologist)

Sponsors & Collaborators

• Zunyi Medical College: lead

Study Sites (3)

children's hospital of Guiyang

Guiyang, Guizhou, 550000, China

Location

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

Location

The first people hospital of zunyi

Zunyi, Guizhou, 563000, China

Location

Related Publications (3)

• 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.

  PMID: 26676711 BACKGROUND

• 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.

  PMID: 28927978 BACKGROUND

• 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.

  PMID: 26080338 BACKGROUND

MeSH Terms

Interventions

Ceftazidime; Appendectomy

Intervention Hierarchy (Ancestors)

Cephaloridine; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• yuanmei Liu

  Zunyi Medical College

  STUDY CHAIR

• peihong Yan, MD

  Children's hospital of guiyang

  STUDY DIRECTOR

• Shengli Gu, MD

  Zunyi First People's Hospital

  STUDY DIRECTOR

• Lei Geng, MD

  Affiliated hospital of Binzhou

  STUDY DIRECTOR

• Ziyong Li, MD

  Children's hospital of Dalian

  STUDY DIRECTOR

• Guoqing He, MD

  People's Hospital of Anshun City of Guizhou Province

  STUDY DIRECTOR

• Xuanzao Wu, MD

  Medical university of Guizhou

  STUDY DIRECTOR

• Guohong Yang

  people hospital of Suiyang

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of pediatric surgery

Study Record Dates

• First Submitted: November 18, 2018
• First Posted: November 27, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)