NCT03106467

Practical Advantages of Single-port Over Three-port Laparoscopic Appendectomy in Children

Practical Advantages of Single-port Over Conventional Three-port Laparoscopic Appendectomy in Children: A Randomized Controlled Trial of 400 Cases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Hallym University Medical Center · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Appendicitis

Interventions

Type	Name	Description
PROCEDURE	Single-port laparoscopic appendectomy	Single-port laparoscopic appendectomy: A 1.5 cm skin incision is made inside the umbilicus and single port is introduced through it. The appendix is manipulated by a combination of a 5-mm scope, angulated, and straight instruments. The periappendiceal vessels and appendix are ligated and divided. Specimen is delivered via the transumbilical port. Umbilical fascia and skin are routinely closed.
PROCEDURE	Three-port laparoscopic appendectomy	Three-port laparoscopic appendectomy: CLA requires the introduction of a 30-degree 5-mm or 10-mm rigid scope through a 0.5 - 1.0 cm intra umbilical incision. Two additional 5-mm incisions are made outside umbilicus. Appendectomy is performed in the same manner as described for the SLA above. The umbilical fascia and skin are routinely closed.

Timeline

• Start date: 2014-11-11
• Primary completion: 2016-06-30
• Completion: 2016-08-31
• First posted: 2017-04-10
• Last updated: 2017-04-10

Locations

1 site across 1 country: South Korea