Appendicitis AcuteAppendicitisNCT06363318
Comparison of Open and Laparoscopic Appendectomy in Pediatric Population
A study testing Laparoscopic appendicectomy in people with Appendicitis Acute, run by King Edward Medical University at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Appendicitis Acute
- What is being tested?
- Laparoscopic appendicectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of age 7-12 years of either gender diagnosed as acute appendicitis
- pediatric appendicitis score >4
Who cannot join
- Children with comorbidities,
- Perforated appendix
- Appendicular mass (on clinical examination). -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Appendicitis Acute
- Being tested
- Laparoscopic appendicectomy
- Keywords
- Appendicitis, children, laparoscopic appendectomy, open appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic appendicectomyProcedure or surgery
Also called open appendicectomy
In group A laparoscopic appendicectomy was done while in group B Open appendicectomy was done
| Study group | Role | What they receive |
|---|---|---|
| Group A laparoscopic appendicectomy | Experimental | In Group A (50 patients) laparoscopic appendicectomy was done Receives: Procedure: Laparoscopic appendicectomy |
| Group B open appendicectomy | Active comparator | In Group B(50 patients) open appendicectomy was done Receives: Procedure: Laparoscopic appendicectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
from time of incision to skin closure
Measured: during surgery
wound infection
It was labelled if there was redness, swelling or pus present at surgical wound site
Measured: 10 days
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.
Measured: 5 days
Postoperative pain
It was measured by using visual analogue scale (VAS), which consists of score minimum zero to maximum ten score
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Jul 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- children were randomly divided in two groups. In group A, laparoscopic appendectomy was done. In group B, open appendectomy was done
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Sharif, King Edward Medical University
- Investigators
- Muhammad Sharif, FCPS, Study chair, King edward Medical University/Mayo Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363318
- Sponsor's protocol ID
- 0003
- Acronym
- Appendicitis
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will be shared on demand
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Open and Laparoscopic Appendectomy in Pediatric Population
- ClinicalTrials.gov ID
- NCT06363318
- Acronym / sponsor ID
- Appendicitis / 0003
- Conditions
- Appendicitis Acute
- Keywords
- Appendicitis, children, laparoscopic appendectomy, open appendectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- children were randomly divided in two groups. In group A, laparoscopic appendectomy was done. In group B, open appendectomy was done
| Arm | Type | Receives |
|---|---|---|
| Group A laparoscopic appendicectomy | Experimental | Procedure: Laparoscopic appendicectomyIn Group A (50 patients) laparoscopic appendicectomy was done |
| Group B open appendicectomy | Active comparator | Procedure: Laparoscopic appendicectomyIn Group B(50 patients) open appendicectomy was done |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children of age 7-12 years of either gender diagnosed as acute appendicitis
- pediatric appendicitis score >4
Key exclusion criteria (3 listed)
- Children with comorbidities,
- Perforated appendix
- Appendicular mass (on clinical examination). -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic appendicectomyAlso: open appendicectomyIn group A laparoscopic appendicectomy was done while in group B Open appendicectomy was done | Procedure or surgery | Group A laparoscopic appendicectomy, Group B open appendicectomy |
Primary outcome
Operative time
Time frame: during surgery
from time of incision to skin closure
wound infection
Time frame: 10 days
It was labelled if there was redness, swelling or pus present at surgical wound site
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: No. will be shared on demand
Related trials for Appendicitis Acute
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
Not yet recruitingPhase 2
Patient Choice Between Antibiotics and Appendectomy in Uncomplicated Appendicitis (FRENCH 47 - ALACARTE)
Acute Appendicitis
Active, not recruitingObservational study
Retrospective Acute Care Appendectomy Study
Acute Appendicitis
Not yet recruiting
Immediate Laparoscopic Appendectomy Versus Interval Laparoscopic Appendectomy for Early Appendicular Mass
Appendicular Mass, Acute Appendicitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Sharif, FCPS study chair
King edward Medical University/Mayo Hospital Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic appendicectomy in people with Appendicitis Acute, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: during surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.