AppendectomyNCT03947372
Comparison of Outcomes After Laparoscopic Versus Open Appendectomy in Acute Appendicitis
A study testing Appendectomy in people with Appendectomy and Pain, Postoperative, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial summary
A comparison study was performed between laparoscopic appendectomy and open appendectomy in acute setting in tertiary hospital to access the outcome of postoperative pain and hospital stay. Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Appendectomy, Pain, Postoperative, Length of Stay
- What is being tested?
- Appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Feb 2015to 20 Aug 2015
- 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 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- with acute appendicitis confirmed clinically by pain in right iliac fossa accompanied by right iliac fossa tenderness, elevated leukocyte count (>8*109/ml) without a palpable mass and on radiological investigation admitted through emergency department were included in the study.
Who cannot join
- • Perforated appendix (had been assesses on abdominal ultrasound or per-operatively.
- Palpable mass in the right lower quadrant as assessed by clinical exam.
- History of Co-morbidities e.g. known diabetic, known hypertensive, cirrhosis as shown by ultrasonography and coagulation disorder (to be determined by low platelet count; <140 *109, deranged PT and APTT).(PT=13sec, APTT= 33 sec)
- Patients unfit for surgery (ASA Grade III/IV).
- Patient who did not give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
A comparison study was performed between laparoscopic appendectomy and open appendectomy in acute setting in tertiary hospital to access the outcome of postoperative pain and hospital stay. As the popularity of laparoscopic appendectomy has failed in major tertiary hospital due to huge amount of patient load in which open appendectomy was performed.This study was performed to prove that outcome of laparoscopic appendectomy are far better than open appendectomy and to increase the use of laparoscopic surgery in acute settings
Read the detailed description
Introduction:
Open appendicectomy has been a safe and usually opted mode of operation for acute appendicitis for more than a century, but since last 10 years laparoscopic appendicectomy is gaining popularity, although still not as popular as laparoscopic cholecystectomy. Comparison of these two is studied in terms of pain outcome as patient perceives and length of hospital stay.
OBJECTIVES:
The objective of this study was to compare the outcome of open appendectomy and laparoscopic appendectomy in patients with acute appendicitis.
STUDY DESIGN: Randomized control trial
SETTING:
Surgical Unit I, Services Hospital, Lahore
DURATION OF STUDY:
Duration of my study was six months after the approval of synopsis i.e 21-02-2015 to 20-08-2015.
SAMPLE SIZE:
Was calculated using WHO method of calculating sample size.
SAMPLING TECHNIQUE:
Non probability consecutive sampling.
DATA COLLECTION PROCEDURE:
All patients fulfilled the inclusion criteria was admitted through the emergency after taking approval from hospital Ethical committee. A detailed history had been taken including demographic data (age, address). Patients was requested to sign an informed consent. They had been assured regarding confidentiality and expertise used for the procedure. All procedures was done by a single operating surgical team to control bias. All the data/variables was recorded on a specially designed Performa attached which are post-op pain at 12hrs and 24 hrs, post-Op stay and patient satisfaction score.
- Conditions
- Appendectomy, Pain, Postoperative, Length of Stay
- Being tested
- Appendectomy
- Keywords
- Open Appendectomy, Laparoscopic Appendectomy, post-operative pain, Hospital stay
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppendectomyProcedure or surgery
removal of acutely inflamed appendix
| Study group | Role | What they receive |
|---|---|---|
| OA (open Appendectomy) | Active comparator | Open Appendectomy Receives: Procedure: Appendectomy |
| LA (Laparoscopic Appendectomy) | Experimental | Laparoscopic Appendectomy Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Post-operative pain
Visual Analogue Score at 12 and 24 hours after surgery . Score 0-10 where '0 shows no distress and '10' shows severe distress.
Measured: patient was assessed after 12 and 24 hours of surgery and change noted in 24 hour
Hospital Stay
Had been the total number of days spent in hospital during the same admission (from date of operation till date of discharge).Patient had been discharged as soon as bowel sounds are audible, passed flatus and resumed oral feeding.
Measured: patient was assessed from 1 to 6 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start21 Feb 2015
- Primary completion20 Aug 2015
- Study completion20 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendectomyStudies 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
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Safia Zahir Ahmed, Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947372
- Sponsor's protocol ID
- IRB/451/SIMS
- Status last verified
- May 2019
- First submitted
- 8 May 2019
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: share of Abstract and data to be shared on request
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes After Laparoscopic Versus Open Appendectomy in Acute Appendicitis
- ClinicalTrials.gov ID
- NCT03947372
- Acronym / sponsor ID
- IRB/451/SIMS
- Conditions
- Appendectomy, Pain, Postoperative, Length of Stay
- Keywords
- Open Appendectomy, Laparoscopic Appendectomy, post-operative pain, Hospital stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- 21 Feb 2015 (actual)
- Primary completion
- 20 Aug 2015 (actual)
- Study completion
- 20 Aug 2015 (actual)
- First posted
- 13 May 2019 (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.
A comparison study was performed between laparoscopic appendectomy and open appendectomy in acute setting in tertiary hospital to access the outcome of postoperative pain and hospital stay. As the popularity of laparoscopic appendectomy has failed in major tertiary hospital due to huge amount of patient load in which open appendectomy was performed.This study was performed to prove that outcome of laparoscopic appendectomy are far better than open appendectomy and to increase the use of laparoscopic surgery in acute settings
Detailed description
Introduction:
Open appendicectomy has been a safe and usually opted mode of operation for acute appendicitis for more than a century, but since last 10 years laparoscopic appendicectomy is gaining popularity, although still not as popular as laparoscopic cholecystectomy. Comparison of these two is studied in terms of pain outcome as patient perceives and length of hospital stay.
OBJECTIVES:
The objective of this study was to compare the outcome of open appendectomy and laparoscopic appendectomy in patients with acute appendicitis.
STUDY DESIGN: Randomized control trial
SETTING:
Surgical Unit I, Services Hospital, Lahore
DURATION OF STUDY:
Duration of my study was six months after the approval of synopsis i.e 21-02-2015 to 20-08-2015.
SAMPLE SIZE:
Was calculated using WHO method of calculating sample size.
SAMPLING TECHNIQUE:
Non probability consecutive sampling.
DATA COLLECTION PROCEDURE:
All patients fulfilled the inclusion criteria was admitted through the emergency after taking approval from hospital Ethical committee. A detailed history had been taken including demographic data (age, address). Patients was requested to sign an informed consent. They had been assured regarding confidentiality and expertise used for the procedure. All procedures was done by a single operating surgical team to control bias. All the data/variables was recorded on a specially designed Performa attached which are post-op pain at 12hrs and 24 hrs, post-Op stay and patient satisfaction score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OA (open Appendectomy) | Active comparator | Procedure: AppendectomyOpen Appendectomy |
| LA (Laparoscopic Appendectomy) | Experimental | Procedure: AppendectomyLaparoscopic Appendectomy |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- with acute appendicitis confirmed clinically by pain in right iliac fossa accompanied by right iliac fossa tenderness, elevated leukocyte count (>8*109/ml) without a palpable mass and on radiological investigation admitted through emergency department were included in the study.
Key exclusion criteria (5 listed)
- • Perforated appendix (had been assesses on abdominal ultrasound or per-operatively.
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 |
|---|---|---|
| Appendectomyremoval of acutely inflamed appendix | Procedure or surgery | LA (Laparoscopic Appendectomy), OA (open Appendectomy) |
Primary outcome
Mean Post-operative pain
Time frame: patient was assessed after 12 and 24 hours of surgery and change noted in 24 hour
Visual Analogue Score at 12 and 24 hours after surgery . Score 0-10 where '0 shows no distress and '10' shows severe distress.
Hospital Stay
Time frame: patient was assessed from 1 to 6 days after surgery
Had been the total number of days spent in hospital during the same admission (from date of operation till date of discharge).Patient had been discharged as soon as bowel sounds are audible, passed flatus and resumed oral feeding.
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 13 May 2019.
- Individual participant dataSharing planned: Yes. share of Abstract and data to be shared on request
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Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
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Quality of Life and Pain After Appendectomy in Children
Chronic Pain, Postoperative, Quality of Life
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Hospital Based Continuous Patient Monitoring System
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appendectomy in people with Appendectomy and Pain, Postoperative, run by Services Hospital, Lahore 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 1 inclusion and 5 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 13 May 2019. 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?
Mean Post-operative pain (time frame: patient was assessed after 12 and 24 hours of surgery and change noted in 24 hour). The study lists 2 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 13 May 2019.