Diseases rising is almost a certainty among the

Diseases of the gallbladder are common and costly1.
In a country like India, with its ethnic background and increasing age, the
incidence rising is almost a certainty among the obese females with increasing
age1,2. The rising epidemic of obesity and the metabolic syndrome
predicts an escalation of cholesterol gallstone frequency1,3.
Gallstone disease in childhood, once considered rare, has become increasingly
recognized with similar risk factors as those in adults, particularly obesity.
The incidence of Gallbladder cancer is also high, particularly in Indians.

Over the past years, there has been substantial
development in cholecystectomy techniques, as well as in the pre- and
post-operative management of patients. The open surgical procedure with a large
incision (OC)4 has been succeeded by small incision open
cholecystectomy (SIOC)5, laparoscopic cholecystectomy6
, single port laparoscopic cholecystectomy technique7 and robotic
cholecystectomy8. The introduction of laparoscopic cholecystectomy
in 1989 further increased the cholecystectomy rate10,11. It is essential to scrutinise such changes in
surgical technology in terms of cost and quality of life, to ensure fair
distribution of resources.

Although
Laparoscopic Cholecystectomy is being done more commonly, there have always
been questions raised regarding its benefits over Open Cholecystectomy. It has
also been stated that Open can be preferred as it offers less operation time
and Laparoscopic method gives no benefit in terms of complications12,13. Similar findings were reported in an
expertise-based randomised controlled trial14. The
aim of the present study is to compare Open and Laparoscopic Cholecystectomy
 concerning costs and quality of
life using the data obtained in this study and to provide data for further
meta-analysis.

There is sparse literature on the
cost-effectiveness of one surgery over other and the quality of life
thereafter. Hence, addressing this research gap will help the surgeon in
selecting one operation over other with proper mobilization of available
resources.

 

OBJECTIVES :  

Primary
objectives:

1.    
To find out the
cost-effectiveness of Open and Laparoscopic Cholecystectomy.

2.    
To compare the health
related quality of life among patients treated with Open and Laparoscopic
Cholecystectomy.

 

Secondary
objectives:

1.    
To identify and determine
complications within the time of discharge, operative time, length of hospital
stay, conversion rate, frequency of ambulatory surgery and readmissions within
30 days.

 

METHODOLOGY:

Study
Design

After the approval of Ethics Committee of my
institution, I plan to carry out my study as described below.

Study Type: Prospective Comparative Study.

Study Site: Department of Surgery of a tertiary care
hospital, Ahmedabad.

Study Duration: Two months between May 2018 and September 2018.

Study Method: Written informed consent of the patients
fulfilling the inclusion and exclusion criteria will be taken. Patients will be followed from the time of
admission, perioperative period, till the time of discharge. Detailed case
report form is developed to record information on demographic data, admission
details, present history findings, past medical history of Diabetes, Hypertension
and to record the pre-operative and post-operative details. Patients with
complications will be followed till 30 days and all relevant information will
be noted in the case report form. The economic assessment will be conducted
from a societal perspective, calculating both direct public healthcare costs
and indirect costs generated by the loss of productivity (sick leave). Cost
generating posts in health care will be calculated from the time the patient
was admitted for surgery. Health-related
quality of life will be assessed using questions concerning patient mobility,
self-care, usual activities, pain/discomfort and anxiety/depression.

Data
Analysis: Data
entered in an excel sheet will be analyzed by SPSS 16.0 (Statistical Package
for Social Sciences; IBM, Chicago, USA) software. Statistical comparisons
between OC and LC groups will be made with Student’s t test
for categorical variables. Statistical significance is defined as P<0.05. Interventions: None. Study Population Inclusion Criteria: 1.     All patients admitted for elective cholecystectomies, irrespective of age or gender. 2.     Patient willing to Participate in Study . Exclusion criteria:        1.     Patients with critical illness. 2.     Medically unfit for surgery. 3.     Cholecystectomy performed as a part of other Surgery.   Sampling All the patients admitted in this hospital for elective cholecystectomy within the Study Duration, satisfying the inclusion and exclusion criteria's will be included in this study. IMPLICATIONS : A.    If this study can establish significant cost-effectiveness of one operation over other, the operation can be considered more often for elective cholecystectomy, especially when resources are to be taken care of. B.     Patient satisfaction of the surgery can be greatly increased if better health related quality of life after surgery is established. C.     When the operation, other than the one proved better is selected, proper counseling of the patient should be done, explaining the reasons of choosing the operation, costs that will be incurred, the problems he/she might face and precautions to be taken for those problems.  

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