Clinical trial NCT03947372: 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
Overall status: COMPLETED
Phase: NA
Conditions: Appendectomy
Pain, Postoperative
Length of Stay
Keywords: Open Appendectomy
Laparoscopic Appendectomy
post-operative pain
Hospital stay
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2019-05-13
Enrollment: 116
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Post-operative pain
timeFrame: patient was assessed after 12 and 24 hours of surgery and change noted in 24 hour
measure: Hospital Stay
timeFrame: patient was assessed from 1 to 6 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: services Hospital
state: Punjab
Study officials:
References: