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

NCT03106467 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2017-04-10

No results posted yet for this study

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.

Conditions

  • Appendicitis

Interventions

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.

Sponsors & Collaborators

  • Hallym University Medical Center

    lead OTHER

Principal Investigators

  • Soo Min Ahn, MD · Division of Pediatric Surgery, Hallym University Sacred Heart Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-11
Primary Completion
2016-06-30
Completion
2016-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03106467 on ClinicalTrials.gov