Comparison of Open and Laparoscopic Appendectomy in Pediatric Population

NCT06363318 | Completed DMC

• 1 other identifier: 0003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: In the era of minimally invasive surgery, changing trends are towards laparoscopic surgery, first introduced in 1983. Now the preferred operation for children with appendicitis, laparoscopic appendectomy is associated with a reduced risk of wound infection, less postoperative pain and shorter hospital stay as compared to open appendectomy. Objectives: To compare the outcome of open and laparoscopic appendectomy in children presenting with appendicitis in terms of operative time, postoperative pain, wound infection and hospital stay.

Conditions

Appendicitis Acute

Keywords

Appendicitis; children; laparoscopic appendectomy; open appendectomy

Outcome Measures

Primary Outcomes (4)

• Operative time

  from time of incision to skin closure

  during surgery

• wound infection

  It was labelled if there was redness, swelling or pus present at surgical wound site

  10 days

• Hospital stay

  It was measured in terms of days required to stay in hospital after surgery. The start time will be the day of operation and end time was the day of discharge from hospital.

  5 days

• Postoperative pain

  It was measured by using visual analogue scale (VAS), which consists of score minimum zero to maximum ten score

  48 hours

Study Arms (2)

Group A laparoscopic appendicectomy

EXPERIMENTAL

In Group A (50 patients) laparoscopic appendicectomy was done

Procedure: Laparoscopic appendicectomy

Group B open appendicectomy

ACTIVE COMPARATOR

In Group B(50 patients) open appendicectomy was done

Procedure: Laparoscopic appendicectomy

Interventions

Laparoscopic appendicectomy PROCEDURE

In group A laparoscopic appendicectomy was done while in group B Open appendicectomy was done

Also known as: open appendicectomy

Group A laparoscopic appendicectomy; Group B open appendicectomy

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of age 7-12 years of either gender diagnosed as acute appendicitis
• pediatric appendicitis score \>4

You may not qualify if:

• Children with comorbidities,
• Perforated appendix
• Appendicular mass (on clinical examination). -

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

Muhammad Sharif

Lahore, Punjab Province, 53711, Pakistan

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Muhammad Sharif, FCPS

  King edward Medical University/Mayo Hospital Lahore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Model Details: children were randomly divided in two groups. In group A, laparoscopic appendectomy was done. In group B, open appendectomy was done

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 12, 2024
• Study Start: July 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)