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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| postintervention pain scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| children's hospital of Guiyang | Guiyang | Guizhou | 550000 | China | ||
| Affiliated Hospital of Zunyi Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26676711 | Background | 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. | |
| 28927978 | Background |
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| ID | Term |
|---|---|
| D002442 | Ceftazidime |
| D001062 | Appendectomy |
| ID | Term |
|---|---|
| D002509 | Cephaloridine |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
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| appendectomy | Procedure | APPT group consisted of admission to the hospital with promptinitiation of intravenous antibiotics and appendectomy |
|
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 |
| 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 |
| 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 |
| Diarrhea | Adverse effects of the antibiotic treatment during the conservation treatment | 7 days |
| Incisional hernia | Postintervention complication included incisional hernia occurring within1year after the operative procedure as diagnosed by surgeon . | 1 year |
| 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 |
| 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 |
| Zunyi |
| Guizhou |
| 563000 |
| China |
| The first people hospital of zunyi | Zunyi | Guizhou | 563000 | China |
| 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. |
| 26080338 | 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. |
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |