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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Hallym University Medical Center

Current Primary Outcome:

  • Post-operative pain (visual analogue scale of pain ranging 0-10) [ Time Frame: up to postoperative day 7 ]
    Post-operative pain is measured by visual analogue scale of pain ranging 0-10.
  • Cosmetic satisfaction (visual analogue scale of cosmetic result ranging 1-10) [ Time Frame: at postoperative 12 months ]
    Cosmetic satisfaction is measured by visual analogue scale of cosmetic result ranging 1-10.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Wound complications [ Time Frame: up to postoperative 3 months ]
    Wound complications include port site seroma collection and abscess formation.
  • Intra-abdominal complications [ Time Frame: up to postoperative 3 months ]
    Intra-abdominal complications include radiologically confirmed bowel ileus or peritoneal abscess formation.
  • Operation time [ Time Frame: on postoperative day 1 ]
    OT is defined as the duration of surgery, from skin incision to application of wound dressing.
  • Post-operative hospital stay [ Time Frame: at postoperative 2 weeks ]
    Post-operative hospital stay is the days between a day after surgery and discharge. Operation day is considered as day 0.


Original Secondary Outcome: Same as current

Information By: Hallym University Medical Center

Dates:
Date Received: March 27, 2017
Date Started: November 11, 2014
Date Completion:
Last Updated: April 7, 2017
Last Verified: March 2017