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NCT Number: NCT06363318

Comparison of Open and Laparoscopic Appendectomy in Pediatric Population

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.

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Key information

Conditions

Appendicitis Acute Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muhammad Sharif

Lahore, Punjab Province, 53711, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Laparoscopic appendicectomy

Procedure

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

Other names: open appendicectomy

Primary outcomes

  1. Operative time

    Time frame: during surgery

    from time of incision to skin closure

  2. wound infection

    Time frame: 10 days

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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Acronym: Appendicitis

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 12, 2024
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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