Antibiotic Therapy vs Laparscopic Appendectomy in Pediatric Chronic Appendicitis (ATvsLAAPT)
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|ClinicalTrials.gov Identifier: NCT03754387|
Recruitment Status : Enrolling by invitation
First Posted : November 27, 2018
Last Update Posted : November 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Appendicitis||Drug: Ceftazidime Procedure: appendectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Mutil-institutions Comparing Antibiotic Therapy With Laparscopic Appendectomy in Pediatric Chronic Appendicitis|
|Estimated Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2022|
Active Comparator: 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).
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.
Experimental: 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.
APPT group consisted of admission to the hospital with promptinitiation of intravenous antibiotics and appendectomy
- Success rate [ Time Frame: 1 year ]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).
- The rate of recurrence [ Time Frame: 1 year ]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.
- postintervention pain scores [ Time Frame: 1 year ]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.
- Wound infection [ Time Frame: 30 days ]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.
- pneumonia [ Time Frame: 7days ]Postintervention complication included pneumonia occurring within 7days after the operative procedure as diagnosed by clinical presentation and chest X-ray or CT-scan.
- Diarrhea [ Time Frame: 7 days ]Adverse effects of the antibiotic treatment during the conservation treatment
- Incisional hernia [ Time Frame: 1 year ]Postintervention complication included incisional hernia occurring within1year after the operative procedure as diagnosed by surgeon .
- Bowel obstruction [ Time Frame: 1 year ]Postintervention complication included bowel obstruction occurring within1year after the operative procedure as diagnosed by clinical presentation and abdominal X-ray or CT-scan.
- persistent abdominal or incisional pain [ Time Frame: 1 year ]Postintervention complication included persistent abdominal or incisional pain occurring within1year after the operative procedure as diagnosed by surgeon .
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754387
|children's hospital of Guiyang|
|Guiyang, Guizhou, China, 550000|
|Affiliated Hospital of Zunyi Medical University|
|Zunyi, Guizhou, China, 563000|
|The first people hospital of zunyi|
|Zunyi, Guizhou, China, 563000|
|Study Chair:||yuanmei Liu||Affiliated Hospital of Zunyi Medical University|
|Study Director:||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 Guizhou Province|
|Study Director:||Xuanzao Wu, MD||Medical university of Guizhou|
|Study Director:||Guohong Yang||people hospital of Suiyang|