Comparison of Open and Laparoscopic Appendectomy in Pediatric Population

Not Applicable

Completed

• Conditions: Appendicitis Acute
• Interventions: Procedure: Laparoscopic appendicectomy

• Registration Number: NCT06363318
• Lead Sponsor: King Edward Medical University

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.

Detailed Description

A total of 100 children presenting with acute appendicitis were included in this study, In group A, patients were undergone laparoscopic appendectomy.

In group B, patients were undergone open appendectomy. During surgery, operative time was noted. After surgery, patients were shifted to surgical wards and were followed-up there till discharge. Patients were followed regularly by the researcher for mean post-operative pain at 24 hours. At discharge, hospital stay was noted. Then patients followed up in outpatient department for 10 days for any evidence of wound infection.

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Study First Submitted: 2024-03-30
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-10
• Last Update Submitted: 2024-04-11
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Children of age 7-12 years of either gender diagnosed as acute appendicitis
2. pediatric appendicitis score >4

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Exclusion Criteria

1. Children with comorbidities,
2. Perforated appendix
3. Appendicular mass (on clinical examination). -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A laparoscopic appendicectomy	Laparoscopic appendicectomy	In Group A (50 patients) laparoscopic appendicectomy was done
Group B open appendicectomy	Laparoscopic appendicectomy	In Group B(50 patients) open appendicectomy was done

Primary Outcome Measures

Name	Time	Method
Postoperative pain	48 hours	It was measured by using visual analogue scale (VAS), which consists of score minimum zero to maximum ten score
Operative time	during surgery	from time of incision to skin closure
wound infection	10 days	It was labelled if there was redness, swelling or pus present at surgical wound site
Hospital stay	5 days	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.

Trial Locations

Locations (1)

Muhammad Sharif; 🇵🇰 Lahore, Punjab, Pakistan