PROTOCOL FOR SUBMISSION OF THESIS FOR THE

AWARD OF DEGREE OF DIPLOMATE OF NATIONAL

BOARD
GOVERNMENT MEDICAL COLLEGE ANANTNAG
DR. SHAHABUDDIN
SESSION 2023
(DNB TRAINEE GENERAL SURGERY)

TITLE OF THESEIS
“Evaluation of Pre-operative Predictors of difficult
laparoscopic cholecystectomy in a newly established medical
college – Prospective observational study.”

GUIDE
PROF. DR. MUMTAZ DIN WANI
PROF. POSTGRADUATE DEPARTMENT OF GENERAL & MINIMAL ACCESS SURGERY,
GOVERNMENT MEDICAL COLLEGE AND ASSOCIATED HOSPITAL, ANANTNAG.
 INTRODUCTION

 Cholelithiasis- commonest health problems encountered among surgical practice

worldwide with prevalence of 10-15% in developed countries and 10-22% in India.

 The frequently performed procedure for cholelithiasis is cholecystectomy.

 Currently the standard procedure is laparoscopic cholecystectomy(LC) done for gall

bladder stones because it is less invasive, less tissue injury, less post- operative pain,
less hospital stay, faster recovery, better cosmesis and less cost to the hospital as
compared to open cholecystectomy.

 Difficult LC is a stressful condition for surgeons, which is followed by higher risk of

biliary, vasculature and visceral injuries.

 Pre-operative predictors that are related to difficult LC are landmarks for surgeons to
assess the possibilities for overcoming difficulties and making early decision about
conversion to an open surgery.

 In this work, we will develop a scoring method, as suggested by Randhawa and

Pujahari, to predict the level of difficulty in LC before to surgery and to link it with
our level of difficulty during surgery.
 PROJECT TITLE

“Evaluation of Pre-operative Predictors of difficult laparoscopic

cholecystectomy in a newly established medical college – Prospective
observational study.”

AIMS & OBJECTIVES

 To evaluate the Pre-operative Predictors of difficult laparoscopic

cholecystectomy in a newly established medical college.
 To correlate these pre-operative predictors with intra-operative predictors of
difficult laparoscopic cholecystectomy.
 Validate these variables.
 MATERIAL AND METHODS

STUDY DESIGN
 This is a prospective, open-label, observational study after approval by
institutional Scientific and Ethics Committee, shall be conducted in the
Department of General Surgery, Government Medical College Anantnag and
Associated Hospital from April 2024 to April 2026 (24 Months) and shall be
carried out in accordance with Good Clinical Practice Guidelines.

 Patients with ultrasound documented gallbladder disease scheduled for elective

laparoscopic cholecystectomy and who satisfy the required inclusion and
exclusion criteria before the study shall be included in this study.

 The study population will include all the patients with symptomatic gallbladder
disease regardless of their gender. The selection of the patients will be made pre
operatively on the basis of history, physical examination, radiological and
laboratory diagnostic evidence of gallbladder disease.

STUDY PERIOD
 For a period of 24 months and shall be carried out in accordance with Good
Clinical Practice Guidelines.
 INCLUSION CRITERIA
 ASA Score< 2
Patients of either sex and all age groups
Patients with ultrasound documented gallbladder disease scheduled for elective
Laparoscopic Cholecystectomy
EXCLUSION CRITERIA
Cases of known or suspected gall bladder malignancy
Coagulopathies (uncorrected)
History of jaundice (obstructive or due to liver parenchymal disease) in the
recent past
Choledocholithiasis, cholangitis and previous biliary tract surgery
Cases having contraindication to laparoscopic abdominal surgery
Patients who did not give Informed Consent
ASA score >2
 STUDY PROCEDURE

 Patients with ultrasound documented gallbladder disease scheduled for elective

Laparoscopic Cholecystectomy and who satisfy the required inclusion and exclusion
criteria before the study shall be included in this study.

PRE-OPERATIVE

 After the OPD work- up, the scores were given on the basis of history, clinical examination
and sonological findings (Table 2) one-day prior to surgery on admission. Score up to 5
was defined as Easy, 6–10 as Difficult and 11–15 as Very Difficult.
 SCORING FACTORS (TABLE 2)
1)History
Max Score
Age <50yrs (0). >50yrs (1).
1

Sex Female (0) Male (1)

1

H/O hospitalization N (0). Y (4)

4

2)Clinical Examination

BMI wt (kg)/ht (m²) <25 (0) 25-27.5(1)>27.5(2)

2

Abdominal scar N (0) Infra-umbilical (1)

2

Supra-umbilical (2)

Palpable gallbladder N (0) Y (1)

1

3)Sonography
H/O = history of, N = No, Y = Yes Total Maximum score = 15
Wall thickness Thin (0) Thick >4 mm (2)
(Randhawa J S, Pujahari A K,2 2009)
Pericholecystic collection. N (0) Y (1)
1
 INTRA-OPERATIVE GRADING SYSTEM

 The scoring system ranges from 0 to 10, classified as score of less than 2 (easy), 2
to 4 (moderate), 5–7 (very difficult), and 8 to 10 (extreme).
(Ahmed N, Maaz ul Hassan, Tahira M, Samad A, Rana H N, 2018)
We Intra-operatively defined easy, difficult and very difficult.

Time taken <60 min

no bile spillage
Easy no injury to duct, artery

Time taken 60–120 min bile/stone spillage

Difficult
injury to duct and no conversion

Very difficult Time taken >120 min and conversion

 Review of Literature

Trehan M, Manqotra V, Singh J, Sinqla S, Gautam S S, Gara R , 2023:

The study also identified he factors that can predict the difficulty in Laparoscopic
cholecystectomy and thus complication can be prevented before hand.

Karim S T, Chakravarti S, Jain A, Patel G, Dey S, 2022:

The aim was to assess the different preoperative factors in patient of cholelithiasis and
ascertain the validity of the scoring system devised by Randhawa and Pujahari in pre-
operatively predicting the difficult LC in our hospital scenario

Paul S, Khatanaiar H, Ck A, Rao H K 2022:

An observational study was conducted in patients who underwent Laparoscopic
cholecystectomy (LC) using a scoring system devised by Randhawa etal. to predict
difficult LC preoperatively which was correlated to intra-operative difficulties in actual
surgeries

Yilmaz T V, Eraldemir F C, Vural C, Cinar S, Acar E,Caglayangil S, Bayrak B Y,

Utkan N Z, 2022:
A prospective cross sectional study was conducted to evaluate the association between
plasma Cholecystokinin (CCK) and difficult cholecystectomy and try to explain the
mechanism
 REVIEW OF LITERATURE

Stanisic V, Milicevic M, Kocev N, Stanisic B, 2020:

This study is a continuation of a research regarding identification of predictors of
difficult LC and it used the analysis of routine preoperative clinical parameters
(anamnesis, physical examination, ultrasound, biochemical, hematological findings) in
patients with difficult LC.

 Chen G, Li M, Cao B, Xu Q, Zhang Z, 2022:

Conducted a retrospective study who's aims were to explore risk factors of difficult
Cholecystectomy and to establish a risk prediction model of difficult Cholecystectomy,
in order to reduces the risk of Laparoscopic Cholecystectomy (LC).

Chand P, Kaur M, Bhandari S, 2019:

Conducted a prospective study that aims to aid the prediction of difficult cases
undergoing Laparoscopic Cholecystectomy, (LC) thereby better selection of patient
with the least conversion rates.

Flores A D, Lailson E C, Velazquez A C, Parra A R, 2017:

Conducted a prospective study to analyze C-reactive protein (CRP)as a predictors of
difficult Laparoscopic Cholecystectomy (LC) in a patient with acute calcular
cholecystitis. Ideal cutoff point for CRP was calculated as 11 mg/dl.