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

NCT03106467 | Completed DMC

• 1 other identifier: 2014-I124
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis

Keywords

appendectomy; laparoscopic; single port; randomized

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  at postoperative 12 months

Secondary Outcomes (4)

• Wound complications

  up to postoperative 3 months

• Intra-abdominal complications

  up to postoperative 3 months

• Operation time

  on postoperative day 1

• Post-operative hospital stay

  at postoperative 2 weeks

Study Arms (2)

Single-port laparoscopic appendectomy

EXPERIMENTAL

Single-port laparoscopic appendectomy is performed through single-port which is installed in umbilicus.

Procedure: Single-port laparoscopic appendectomy

Three-port laparoscopic appendectomy

ACTIVE COMPARATOR

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

Interventions

Single-port laparoscopic appendectomy PROCEDURE

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.

Single-port laparoscopic appendectomy

Three-port laparoscopic appendectomy PROCEDURE

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.

Three-port laparoscopic appendectomy

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hallym University Medical Center: lead

Study Sites (1)

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 14068, South Korea

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Soo Min Ahn, MD

  Division of Pediatric Surgery, Hallym University Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 10, 2017
• Study Start: November 11, 2014
• Primary Completion: June 30, 2016
• Study Completion: August 31, 2016
• Last Updated: April 10, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)