Comparison of Open and Laparoscopic Appendectomy in Pediatric Population (Appendicitis)

April 11, 2024 updated by: Muhammad Sharif, King Edward Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 53711
        • Muhammad Sharif

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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). -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A laparoscopic appendicectomy
In Group A (50 patients) laparoscopic appendicectomy was done
Procedure: Laparoscopic appendicectomy
In group A laparoscopic appendicectomy was done while in group B Open appendicectomy was done
Other Names:
  • open appendicectomy
Active Comparator: Group B open appendicectomy
In Group B(50 patients) open appendicectomy was done
Procedure: Laparoscopic appendicectomy
In group A laparoscopic appendicectomy was done while in group B Open appendicectomy was done
Other Names:
  • open appendicectomy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Edward Medical University

Investigators

  • Study Chair: Muhammad Sharif, FCPS, king Edward medical university/mayo hospital lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

March 30, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

will be shared on demand

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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