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

NCT ID: NCT03106467

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-11
• Study Completion Date: 2016-08-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-port laparoscopic appendectomy

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

Group Type: EXPERIMENTAL

Single-port laparoscopic appendectomy

Intervention Type: 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.

Three-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

Group Type: ACTIVE_COMPARATOR

Three-port laparoscopic appendectomy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hallym University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soo Min Ahn, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Pediatric Surgery, Hallym University Sacred Heart Hospital

Locations

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

2014-I124

Identifier Type: -

Identifier Source: org_study_id