Comparison of Open and Laparoscopic Appendectomy in Pediatric Population

NCT ID: NCT06363318

Last Updated: 2024-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-11-30

Brief Summary

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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

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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.

Conditions

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Appendicitis Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

children were randomly divided in two groups. In group A, laparoscopic appendectomy was done. In group B, open appendectomy was done
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A laparoscopic appendicectomy

In Group A (50 patients) laparoscopic appendicectomy was done

Group Type EXPERIMENTAL

Laparoscopic appendicectomy

Intervention Type PROCEDURE

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

Group B open appendicectomy

In Group B(50 patients) open appendicectomy was done

Group Type ACTIVE_COMPARATOR

Laparoscopic appendicectomy

Intervention Type PROCEDURE

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

Interventions

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Laparoscopic appendicectomy

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

Intervention Type PROCEDURE

Other Intervention Names

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open appendicectomy

Eligibility Criteria

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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). -
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Edward Medical University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Sharif

PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammad Sharif, FCPS

Role: STUDY_CHAIR

King edward Medical University/Mayo Hospital Lahore

Locations

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Muhammad Sharif

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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0003

Identifier Type: -

Identifier Source: org_study_id

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