An interventional study of Single-port laparoscopic appendectomy and Three-port laparoscopic appendectomy in Appendicitis, sponsored by Hallym University Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged Up to 15 Years. Per ClinicalTrials.gov, last updated 2017-04-10.
Sponsored by Hallym University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
412 studies on the registry are indexed under Appendicitis; 62 are open to participants now.
This study's enrollment of 400 is above the median of 111 across 246 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Hallym University Medical Center is the lead sponsor of 52 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single-port laparoscopic appendectomy is performed through single-port which is installed in umbilicus.
Procedure: Single-port laparoscopic appendectomy
Three-port laparoscopic appendectomy is performed using conventional three-port technique which needs two additional ports outside umbilicus in addition to trans-umbilical port
Procedure: Three-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.
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.
Post-operative pain (visual analogue scale of pain ranging 0-10)
Post-operative pain is measured by visual analogue scale of pain ranging 0-10.
Time frame: up to postoperative day 7
Cosmetic satisfaction (visual analogue scale of cosmetic result ranging 1-10)
Cosmetic satisfaction is measured by visual analogue scale of cosmetic result ranging 1-10.
Time frame: at postoperative 12 months
Wound complications
Wound complications include port site seroma collection and abscess formation.
Time frame: up to postoperative 3 months
Intra-abdominal complications
Intra-abdominal complications include radiologically confirmed bowel ileus or peritoneal abscess formation.
Time frame: up to postoperative 3 months
Operation time
OT is defined as the duration of surgery, from skin incision to application of wound dressing.
Time frame: on postoperative day 1
Post-operative hospital stay
Post-operative hospital stay is the days between a day after surgery and discharge. Operation day is considered as day 0.
Time frame: at postoperative 2 weeks
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hallym University Medical Center