Perforated Appendicitis
Conditions
Brief summary
The proposed study will investigate whether antibiotic irrigation using a gentamicin/clindamycin solution during laparoscopic appendectomy is superior in preventing postoperative wound infections and IAA in perforated appendicitis compared to suction without irrigation. This will be the first prospective study to compare these two options in pediatric PA.
Detailed description
This study is for pediatric patients who are having an appendectomy and have a perforated appendix. The purpose of this study is to see whether antibiotic irrigation using gentamicin, clindamycin and suction during the surgery works better when compared to suction alone when cleaning the stomach cavity. Arm A patients will have their abdomen irrigated with the antibiotics, gentamycin and clindamycin, and then the wound will be suctioned out. Arm B patients will not have the antibiotic irrigation but will have their wound suctioned.
Interventions
DRUGantibiotic rinse with suction
antibiotic rinse with suction
PROCEDUREsuction only
no irrigation, suction only
Sponsors
Prisma Health-Upstate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
there is no masking after randomization
Intervention model description
Patients will be randomized into 1 of 2 groups. Group "A" will be Antibiotic Irrigation with suction and Group "B" will be Suction Alone.
Eligibility
Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, age 18 years or younger 2. Scheduled to undergo laparoscopic appendectomy 3. Preoperative or intra-operative diagnosis of perforated appendicitis (PA). 4. Willingness to undergo treatments, provide written informed consent, and participate in follow-up.
Exclusion criteria
1. Male or female older than 18 years of age 2. Declined to undergo laparoscopic appendectomy 3. Not willing to provide written informed consent or undergo randomization of treatment 4. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| wound complications | 30 days | The overall objective is to change the postoperative wound complications and IAA after laparoscopic appendectomy for perforated appendicitis in pediatric patients. The outcome will be measured by tracking any wound complications that these patients have and comparing the incidence between treatment arms |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert Gates, MD
Prisma Health
Outcome results
None listed