Postoperative intra-abdominal adhesionsAdhesive small bowel obstructionAppendectomy complications in children. Peritoneal adhesions (postprocedural)
Conditions
Interventions
Intervention 1: Intervention group:At the end of appendectomy (open or laparoscopic), after complete hemostasis, SINGCLEAN hyaluronic acid gel (manufactured in China, CE-approved) will be applied topi
maximum 50 mL).Application: Under sterile conditions by the pediatric surgeon before closure.Storage: 2–20 °C until use.All other surgical and postoperative management will be identical to the control
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1-Children aged 2 to 18 years undergoing appendectomy (either open or laparoscopic) 2-Patients whose parents or legal guardians provide written informed consent 3-Patients with no previous history of abdominal surgery. 4-Patients who are hemodynamically stable and eligible for elective or emergency appendectomy
Exclusion criteria
Exclusion criteria: History of previous abdominal surgery Known allergy or hypersensitivity to hyaluronic acid or any component of the SINGCLEAN gel. History of severe drug allergies or anaphylaxis Patients with severe systemic illness (e.g., sepsis, multi-organ failure) not suitable for safe surgery. Parents or guardians who refuse or withdraw informed consent at any stage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative intestinal adhesions or adhesion-related bowel obstruction within six months, assessed clinically and by imaging or reoperation records. Timepoint: Baseline (post-surgery), and at 1, 3, and 6 months after intervention; final primary outcome assessment at 6 months postoperatively. Method of measurement: Clinical evaluation for bowel obstruction symptoms by blinded pediatric surgeons, supported by abdominal X-ray or ultrasound when indicated, and intra-operative confirmation in reoperated cases. | — |
Secondary
| Measure | Time frame |
|---|---|
| Readmission, reoperation, postoperative complications, and hospital stay length within 6-month follow-up; assessed from clinical records by blinded evaluators. Timepoint: During hospitalization for early complications and hospital stay; at 1, 3, and 6 months post-surgery for readmission and reoperation rates; final analysis at 6 months. Method of measurement: Based on hospital and surgical records, clinical and nursing notes, and parental follow-up interviews; complications, readmission, reoperation, and hospital stay recorded by blinded evaluators using standardized forms. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKhashayar Atqiaee
Mashhad University of Medical Sciences
Outcome results
None listed