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出境医 / 临床实验 / Comparison of Outcomes After Laparoscopic Versus Open Appendectomy in Acute Appendicitis

Comparison of Outcomes After Laparoscopic Versus Open Appendectomy in Acute Appendicitis

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

Condition or disease Intervention/treatment Phase
Appendectomy Pain, Postoperative Length of Stay Procedure: Appendectomy Not Applicable

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
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
Active Comparator: OA (open Appendectomy)
Open Appendectomy
Procedure: Appendectomy
removal of acutely inflamed appendix

Experimental: LA (Laparoscopic Appendectomy)
Laparoscopic Appendectomy
Procedure: Appendectomy
removal of acutely inflamed appendix

Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Locations
Layout table for location information
Pakistan
services Hospital
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
Services Hospital, Lahore
Tracking Information
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
 (submitted: May 8, 2019)
  • 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.
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.

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
Condition  ICMJE
  • Appendectomy
  • Pain, Postoperative
  • Length of Stay
Intervention  ICMJE Procedure: Appendectomy
removal of acutely inflamed appendix
Study Arms  ICMJE
  • Active Comparator: OA (open Appendectomy)
    Open Appendectomy
    Intervention: Procedure: Appendectomy
  • Experimental: LA (Laparoscopic Appendectomy)
    Laparoscopic Appendectomy
    Intervention: Procedure: Appendectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2019)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: share of Abstract and data to be shared on request
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: 1 year
Access Criteria: can be accessed on request
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