Comparison of Outcomes After Laparoscopic Versus Open Appendectomy in Acute Appendicitis

NCT03947372 | Completed DMC

• 1 other identifier: IRB/451/SIMS
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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

Conditions

Appendectomy; Pain, Postoperative; Length of Stay

Keywords

Open Appendectomy; Laparoscopic Appendectomy; post-operative pain; Hospital stay

Outcome Measures

Primary Outcomes (2)

• 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.

  patient was assessed after 12 and 24 hours of surgery and change noted in 24 hour

• 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.

  patient was assessed from 1 to 6 days after surgery

Study Arms (2)

OA (open Appendectomy)

ACTIVE COMPARATOR

Open Appendectomy

Procedure: Appendectomy

LA (Laparoscopic Appendectomy)

EXPERIMENTAL

Laparoscopic Appendectomy

Procedure: Appendectomy

Interventions

Appendectomy PROCEDURE

removal of acutely inflamed appendix

LA (Laparoscopic Appendectomy); OA (open Appendectomy)

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Services Hospital, Lahore: lead

Study Sites (1)

services Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal Investigator

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 13, 2019
• Study Start: February 21, 2015
• Primary Completion: August 20, 2015
• Study Completion: August 20, 2015
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year
• Access Criteria: can be accessed on request

Locations

PA (1)