Clinical trial NCT03106467: Practical Advantages of Single-port Over Three-port Laparoscopic Appendectomy in Children
Official title: Practical Advantages of Single-port Over Conventional Three-port Laparoscopic Appendectomy in Children: A Randomized Controlled Trial of 400 Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Keywords: appendectomy
laparoscopic
single port
randomized
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 400
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite growing popularity, practical advantages of single-port laparoscopic appendectomy (SLA) over conventional three-port laparoscopic appendectomy (CLA) have yet to be established well in pediatric population.

The investigators designed the randomized controlled trial to clarify practical advantages of SLA over CLA in pediatric population. The investigators compared conversion rate, intra-operative adverse events, operating time, wound complications, intra-abdominal complications, and postoperative hospital stay, changes in postoperative pain severity, and cosmetic outcomes during follow up period between SLA and CLA groups.

Detailed description: Currently the single-port laparoscopic appendectomy (SLA) has gained popularity in pediatric population since it was first reported in 1998 by Esposito et al. Nonetheless, the practical advantages of SLA over conventional three-port laparoscopic appendectomy (CLA) have yet to be established well in pediatric population due to lacking and inconsistent high-level evidences from randomized trials and meta-analysis.

Thus far, in addition to overall postoperative hospital stay, complications such as wound abscess and seroma, intra-abdominal abscess and ileus were reported not to be significantly different between SLA and CLA, while SLA might have taken longer operation time in children and adult. Currently, the advertised benefits on postoperative pain and cosmetic results of SLA incurred suspicion because of heterogeneous data inconsistently supporting SLA from a few RCTs especially in pediatric population. Consequently, a consensus regarding the practical superiority of SLA to CLA has still not been reached particularly in children.

To address this issue, the investigators designed the randomized trial to clarify practical benefits of SLA over CLA in pediatric population. For this, the investigators compared conversion rate, intra-operative adverse events, operating time, wound complications, intra-abdominal complications, and postoperative hospital stay, changes in postoperative pain severity, and cosmetic outcomes during follow up period between SLA and CLA groups. Primary end points were postoperative pain severity and cosmetic satisfaction. Secondary endpoints were intra- and post-operative complication rates, operation time, and postoperative hospital stay.

Eligibility criteria: Inclusion Criteria:

* Acute appendicitis was diagnosed in accordance with following clinical, laboratory, and radiographic criteria; history of right lower quadrant pain or periumbilical pain migrating to the right lower quadrant with nausea and/or vomiting. presence direct and indirect tenderness on McBurney's point and/or right lower quadrant guarding. a fever ≥ 38°C and/or white blood cell counts more than 10X10³ cells per mL on complete blood count. diameter of appendix ≥ 6 mm with mural thickening and periappendiceal fat infiltration and/or abdominal fluid collection on appendiceal ultrasonography or abdominopelvic computed tomography.
* Perforated appendicitis: disrupted appendix contour with non-homogenous peritoneal fluid collection in pelvic cavity and/or sub-hepatic space simultaneously with above mentioned clinical, laboratory, and radiographic findings of appendicitis.
* Peri-appendiceal abscess which was preoperatively confirmed by ultrasonographic and/or computed tomographic evidence.

Exclusion Criteria:

* Suspicious diagnosis of appendicitis which was not in accordance with the diagnosis criteria.
* Patients who were subjected to ≥ 2 days of empirical antibiotics therapy for initial symptom prior to diagnosis with acute appendicitis.
* History of coagulation disorders, shock upon admission, previous abdominal surgery, contraindication to general anesthesia, suspected or proven malignancy, and mental illness.

Primary outcomes:
measure: Post-operative pain (visual analogue scale of pain ranging 0-10)
timeFrame: up to postoperative day 7
measure: Cosmetic satisfaction (visual analogue scale of cosmetic result ranging 1-10)
timeFrame: at postoperative 12 months
Secondary outcomes:
measure: Wound complications
timeFrame: up to postoperative 3 months
measure: Intra-abdominal complications
timeFrame: up to postoperative 3 months
measure: Operation time
timeFrame: on postoperative day 1
measure: Post-operative hospital stay
timeFrame: at postoperative 2 weeks
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
Study officials:
affiliation: Division of Pediatric Surgery, Hallym University Sacred Heart Hospital
name: Soo Min Ahn, MD
role: PRINCIPAL_INVESTIGATOR
References: