Antibiotic Therapy vs Laparscopic Appendectomy in Pediatric Chronic Appendicitis

NCT ID: NCT03754387

Last Updated: 2018-11-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-01-01

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.

Conditions

Chronic Appendicitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Antibiotic therapy group

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).

Group Type: ACTIVE_COMPARATOR

Ceftazidime

Intervention Type: 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.

Laparoscopic Appendectomy group

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.

Group Type: EXPERIMENTAL

appendectomy

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DRUG

appendectomy

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

Intervention Type: PROCEDURE

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

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)

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zunyi Medical College

OTHER

Sponsor Role: lead

Responsible Party

zebing Zheng

Head of pediatric surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yuanmei Liu

Role: STUDY_CHAIR

Zunyi Medical College

peihong Yan, MD

Role: STUDY_DIRECTOR

Children's hospital of guiyang

Shengli Gu, MD

Role: STUDY_DIRECTOR

Zunyi First People's Hospital

Lei Geng, MD

Role: STUDY_DIRECTOR

Affiliated hospital of Binzhou

Ziyong Li, MD

Role: STUDY_DIRECTOR

Children's hospital of Dalian

Guoqing He, MD

Role: STUDY_DIRECTOR

People's Hospital of Anshun City of Guizhou Province

Xuanzao Wu, MD

Role: STUDY_DIRECTOR

Medical university of Guizhou

Guohong Yang

Role: STUDY_DIRECTOR

people hospital of Suiyang

Locations

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, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 26676711 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28927978 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26080338 (View on PubMed)

Other Identifiers

ZunyiMU

Identifier Type: -

Identifier Source: org_study_id