Comparison of Open and Laparoscopic Appendectomy in Pediatric Population

Appendicitis Acute Clinical Trial

— Appendicitis  

Official title:

Comparison of Open and Laparoscopic Appendectomy in Pediatric Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06363318
• Other study ID #: 0003
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: April 2024
• Source: King Edward Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Children of age 7-12 years of either gender diagnosed as acute appendicitis

2. pediatric appendicitis score >4

Exclusion Criteria:

1. Children with comorbidities,

2. Perforated appendix

3. Appendicular mass (on clinical examination). -

Related Conditions & MeSH terms

• Appendicitis
• Appendicitis Acute

Intervention

Procedure:
• Laparoscopic appendicectomy
In group A laparoscopic appendicectomy was done while in group B Open appendicectomy was done

Locations

Country	Name	City	State
Pakistan	Muhammad Sharif	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	from time of incision to skin closure	during surgery
Primary	wound infection	It was labelled if there was redness, swelling or pus present at surgical wound site	10 days
Primary	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
Primary	Postoperative pain	It was measured by using visual analogue scale (VAS), which consists of score minimum zero to maximum ten score	48 hours