Condition or disease | Intervention/treatment | Phase |
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Appendectomy Pain, Postoperative Length of Stay | Procedure: Appendectomy | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 116 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Outcomes After Laparoscopic Versus Open Appendectomy in Acute Appendicitis |
Actual Study Start Date : | February 21, 2015 |
Actual Primary Completion Date : | August 20, 2015 |
Actual Study Completion Date : | August 20, 2015 |
Arm | Intervention/treatment |
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Active Comparator: OA (open Appendectomy)
Open Appendectomy
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Procedure: Appendectomy
removal of acutely inflamed appendix
|
Experimental: LA (Laparoscopic Appendectomy)
Laparoscopic Appendectomy
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Procedure: Appendectomy
removal of acutely inflamed appendix
|
Ages Eligible for Study: | 15 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
• Perforated appendix (had been assesses on abdominal ultrasound or per-operatively.
Pakistan | |
services Hospital | |
Lahore, Punjab, Pakistan, 54000 |
Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | May 8, 2019 | ||||||||||||||||||
First Posted Date ICMJE | May 13, 2019 | ||||||||||||||||||
Last Update Posted Date | May 13, 2019 | ||||||||||||||||||
Actual Study Start Date ICMJE | February 21, 2015 | ||||||||||||||||||
Actual Primary Completion Date | August 20, 2015 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Change History | No Changes Posted | ||||||||||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | Comparison of Outcomes After Laparoscopic Versus Open Appendectomy in Acute Appendicitis | ||||||||||||||||||
Official Title ICMJE | Comparison of Outcomes After Laparoscopic Versus Open Appendectomy in Acute Appendicitis | ||||||||||||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Procedure: Appendectomy
removal of acutely inflamed appendix
|
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||
Actual Enrollment ICMJE |
116 | ||||||||||||||||||
Original Actual Enrollment ICMJE | Same as current | ||||||||||||||||||
Actual Study Completion Date ICMJE | August 20, 2015 | ||||||||||||||||||
Actual Primary Completion Date | August 20, 2015 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 15 Years to 45 Years (Child, Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
Listed Location Countries ICMJE | Pakistan | ||||||||||||||||||
Removed Location Countries | |||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT03947372 | ||||||||||||||||||
Other Study ID Numbers ICMJE | IRB/451/SIMS | ||||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Safia Zahir Ahmed, Services Hospital, Lahore | ||||||||||||||||||
Study Sponsor ICMJE | Services Hospital, Lahore | ||||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||||
Investigators ICMJE | Not Provided | ||||||||||||||||||
PRS Account | Services Hospital, Lahore | ||||||||||||||||||
Verification Date | May 2019 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |