Comparison of Outcomes After Laparoscopic Versus Open Appendectomy in Acute Appendicitis
Primary Purpose
Appendectomy, Pain, Postoperative, Length of Stay
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Appendectomy
Sponsored by
About this trial
This is an interventional treatment trial for Appendectomy focused on measuring Open Appendectomy, Laparoscopic Appendectomy, post-operative pain, Hospital stay
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
• 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.
Sites / Locations
- services Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
OA (open Appendectomy)
LA (Laparoscopic Appendectomy)
Arm Description
Open Appendectomy
Laparoscopic Appendectomy
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03947372
Brief Title
Comparison of Outcomes After Laparoscopic Versus Open Appendectomy in Acute Appendicitis
Official Title
Comparison of Outcomes After Laparoscopic Versus Open Appendectomy in Acute Appendicitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 21, 2015 (Actual)
Primary Completion Date
August 20, 2015 (Actual)
Study Completion Date
August 20, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Hospital, Lahore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendectomy, Pain, Postoperative, Length of Stay
Keywords
Open Appendectomy, Laparoscopic Appendectomy, post-operative pain, Hospital stay
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OA (open Appendectomy)
Arm Type
Active Comparator
Arm Description
Open Appendectomy
Arm Title
LA (Laparoscopic Appendectomy)
Arm Type
Experimental
Arm Description
Laparoscopic Appendectomy
Intervention Type
Procedure
Intervention Name(s)
Appendectomy
Intervention Description
removal of acutely inflamed appendix
Primary Outcome Measure Information:
Title
Mean Post-operative pain
Description
Visual Analogue Score at 12 and 24 hours after surgery . Score 0-10 where '0 shows no distress and '10' shows severe distress.
Time Frame
patient was assessed after 12 and 24 hours of surgery and change noted in 24 hour
Title
Hospital Stay
Description
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.
Time Frame
patient was assessed from 1 to 6 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
• 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.
Facility Information:
Facility Name
services Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
share of Abstract and data to be shared on request
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
can be accessed on request
Learn more about this trial
Comparison of Outcomes After Laparoscopic Versus Open Appendectomy in Acute Appendicitis
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