Comparison of Outcomes After Laparoscopic Versus Open Appendectomy in Acute Appendicitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-21

Study Completion Date

2015-08-20

Brief Summary

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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

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Detailed Description

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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

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Appendectomy Pain, Postoperative Length of Stay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OA (open Appendectomy)

Open Appendectomy

Group Type ACTIVE_COMPARATOR

Appendectomy

Intervention Type PROCEDURE

removal of acutely inflamed appendix

LA (Laparoscopic Appendectomy)

Laparoscopic Appendectomy

Group Type EXPERIMENTAL

Appendectomy

Intervention Type PROCEDURE

removal of acutely inflamed appendix

Interventions

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Appendectomy

removal of acutely inflamed appendix

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes