Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04373447 |
| Other study ID # |
lap cholecystectomy 2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2015 |
| Est. completion date |
January 1, 2020 |
Study information
| Verified date |
April 2020 |
| Source |
Zagazig University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Introduction:
In the last decades and due to improvement of medical heath care, large number of elderly
persons were prevalence. Old age usually had cardiopulmonary different diseases. Biliary
problems are high in old age. advancement of laparoscopic that occurred in the last years
made the use of laparoscopy is available in these cardiopulmonary risk patients. many studies
faced the role of laparoscopy in acute cholecystitis in elderly but no studies stated a new
and a safe laparoscopic approach to the patients.
Aim: compare between Fundus-Calot cholecystectomy with low pressure pneumo-peritoneum VS open
cholecystectomy in Emergency cases with cardiopulmonary risk patients as regard
intraoperative data and postoperative complications.
Patients and methods:
This study prospective randomized controlled study was conducted on 374 cases with acute
cholecystitis, biliary colic, mucocele and pyocele of gall bladder in emergency general
surgery department. Patients were divided into 2 groups, Group A: fundus-Calot approach
(235cases) and Group B (235cases): classical open approach
Description:
1. INTRODUCTION Evolving the role of laparoscopy in the last decades in managing of
different surgical diseases especially biliary diseases had made laparoscopic
cholecystectomy of special interest in the field of surgery. The wide spread of use of
laparoscopic cholecystectomy put this surgery in the front line of the commonest
operation performed in digestive system surgery and really put open cholecystectomy a
side.[ Gouma DJ, Rauws EA, Lameris JS. Bile duct injury after cholecystectomy: risk of
mortality substantially higher. NedTijdscr Genseeskd 2004; 148: 1020-24.]
Laparoscopic cholecystectomy advantages are numerous to both the doctors and the
patients. Advantages to the surgeons are safety and rapidity of the operation with
experienced surgeons. To the patients as regard small sized operative wounds, less pain
postoperative, less wound infection and hence rapid discharge from hospital and regain
its usual daily activities . [Stanisic V, Bakic M, Maqgelinic M, Kolasinac H. Babic I.
[Laparoscopic cholecystectomy of acute cholecystitis]. Med Preql 2010; 63: 404-8.]
Despite the fact that laparoscopic approach had many benefits over open approach, yet
many hazards may occur from laparoscopic cholecystectomy starting with viscous injury
during induction of pneumoperitoneum and conversion till fatal biliary and vascular
injuries during blind and insisted dissection of disturbed anatomy and frozen Calot
triangle. these complications may occur with best surgical hands and decreased with
increasing learning curve.[ Russel JC, WalshSJ, Mattie AS, Lynch JT. Bile duct
injuries.1989- 1993: A state wide experience: Connecticut laparoscopic cholecystectomy
registry. Arch Surg 1996; 131:382-8.][ Atmaram DC, Lakshman K. Predictive factors for
conversion of laparoscopic cholecystectomy. Indian J Surg 2011; 73: 42-3] a study put us
on the way to avoid bile duct injuries [5].
The incidence of gall bladder disease increase with advancement of age so that 20-30% of
patients undergo laparoscopic cholecystectomy is elderly patients > 60 years with
cardiopulmonary risks. and increase to 80 % after 90 years .Elderly patients had
cardiopulmonary risks and reduced physiological reserve [Festi D, Dormi A, Capodicasa S,
Staniscia T, Attili AF, Loria P, et al: Incidence of gallstone disease in Italy: results
from a multicenter, population-based Italian study (the MICOL project). World J
Gastroenterol 2008; 14:5282-5289.] [Ratner J, Lisbona A, Rosenbloom M, Palayew M,
Szabolcsi S, Tupaz T: The prevalence of gallstone disease in very old institutionalized
persons. JAMA 1991; 265: 902-903.]. Other study stated lower incidence of acute
cholecystitis in the elderly group of only 6%[ S. W. Lee, S. S. Yang, C. S. Chang, and
H. J. Yeh, "Impact of the Tokyo guidelines on the management of patients with acute
calculous cholecystitis," Journal of Gastroenterology and Hepatology, vol. 24, no. 12,
pp. 1857-1861, 2009.]
Insufflation of CO2 induces both hemodynamic and mechanical effects. Compression of the
vascular system decrease cardiac output due to increase peripheral resistance. Abdominal
distension hinder movement of diaphragm. [ Enciso NJ (2013) Anestesia en la cirugía
laparoscópica abdominal. An Fac med 74(1): 63-70.].
Head up position during laparoscopic cholecystectomy decrease venous return and release
catecholamine in the blood causing increase in peripheral vascular resistance and
myocardium exerts more efforts to pump the blood against high peripheral
resistance.[13][14] [15]
No randomized studies have compared fundus-Callot laparoscopic cholecystectomy with low
pressure pneumoperitoneum with open cholecystectomy in cardiopulmonary risk patients
with urgent cholecystectomy.
The aim of this study was to evaluate and compare the outcome of urgent LC using either
fundus-Callot approach or open approach in cardiopulmonary risk patients as regard
morbidity and mortality.
2. THE AIM OF THE WORK The aim of this study was to evaluate and compare the outcome of
urgent laparoscopic cholecystectomy under low pressure Pneumo-peritoneum using either
fundus-Callot first approach Vs open approach in cardiopulmonary risk patients as regard
morbidity and mortality.
3. Patients and methods Study design: Prospective Randomized controlled clinical study.
Study place: our study was conducted in the surgical emergency unit of our University
Hospitals.
Study period: March 2015 to March 2018. Source of data: Patients admitted with clinical
diagnosis of acute cholecystitis, biliary colic, mucocele or pyocele of gall bladder in
patients with cardiopulmonary diseases.
Sample size: A total of 374 patients with a clinical diagnosis of acute cholecystitis,
biliary colic, mucocele or pyocele of gall bladder in patients with cardiopulmonary diseases.
Sampling method: simple random sample with a balance the data were uploaded into the database
using a standard closed-field electronic form; to guarantee patient anonymity, no information
that could permit patient identification was registered in the database.
Method of sample size calculation: Sample size calculated to be 187 at each group based on
global complications rate difference between open and laparoscopic group from previous paper
with 80% power of study and 95% confidence interval
Patient selection criteria:
A. Inclusion criteria:
1. Age: any age.
2. Sex: Male and Non pregnant female.
3. Patients with cardiopulmonary diseases.
4. Patients who diagnose acute cholecystitis not improving on medical treatment for 48
hours.
5. Patients with biliary colic, mucocele of gall bladder and pyocele of gall bladder.
6. American Society of Anesthesiologist's (ASA) score: grade I, II, III.
Exclusion criteria:
1. ASA grade IV
2. Patients refuse surgery.
3. Documented neurological, renal and Liver disease.
4. Previous percutaneous cholecystostomy
5. Cases not tolerated CO2 insufflation from the start.
6. Other associated problems as acute cholangitis, pancreatitis, gastro-intestinal cancer
or bile duct diseases
Preoperative work up: All patients included in the study underwent:
1. Full clinical examination: pain in right hypochondrium radiated to right shoulder, local
examination revealed tenderness in right hypochondrium or mass and fever.
2. Ultrasonography: thick edematous wall of gall bladder distended gall bladder or stone
impacted in gall bladder neck.
3. Blood investigations :leukocytosis
4. Liver Function Tests.
5. Chest x-ray and pulmonary function test.
6. ECG and Echocardiography.
The patients are admitted to the ward where third generation cephalosporin, metronidazole,
pethidine, proton pump blockers and intravenous fluid were started.
Patients are divided into 2 groups:
Group A (n=187): patients underwent laparoscopic cholecystectomy with low pressure
pneumoperitoneum and initial fundus first cholecystectomy followed by dissection of Calot
triangle (fundus-Calot dissection) Group B (n=187): patients underwent open cholecystectomy
Efforts to decrease bias in the study:
1. For pretrial bias: Good Define objectives. Risk and outcome .Select patients on
probability sample with adequate sample size. Define confound factors and avoid it
2. To avoid during trial bias: Standardize reaction and management of patients
blindly-Objective data use rather than subjective-Good handling of data- plan designed
for drop out
3. To avoid after trial bias: Suitable statistical analysis used-Good and carefully
interpretation-Control of confound
Methods:
The patients were given general anesthesia. The stomach and the urinary bladder were deflated
with naso-gastric tube and a catheter. The anaesthiologist continuously monitor the vital
signs, PO2 and PCO2 of the patients throughout the surgery. Insufflation of the abdomen were
done by either Verres needle or open Hasson techniques. Endoscope was introduced through the
umbilical incision and the other three trocars were introduced in epigastrium(10 mm), right
subcostal(5 mm) and right anterior axillary line at the level of umbilicus(5mm).we started
release of the fundus first by incision of the peritoneum on left side of middle of gall
bladder, and the dissection continued in the peritoneum around the fundus to the other side
in inverted u-shaped figure. Then the fundus of gall bladder is freed from the liver by
coagulation. Then the fundus is grasped to the right shoulder with ease and this help
elevation of the neck of gall bladder into view. We then begin to dissect the cystic duct and
cystic artery with blunt and sharp dissection till critical view of safety appears. The
cystic duct and artery are controlled by clips and divided. Finally the rest of gall bladder
adherent to the liver is removed. A drain is put in gall bladder bed.
Open cholecystectomy: subcostal Kocher incision. The abdominal layer is entered till opening
the peritoneum. By the use of retractors, the neck of gall bladder is exposed and any
adhesion from omentum, colon or duodenum is released carefully. Then we dissect on cystic
duct and artery carefully and they were controlled by Vicryl 2/0 sutures. Then the gall
bladder is freed from its bed. Sometimes, we performed fundus first approach that helped us
greatly to expose neck of gall bladder. Aspiration of the gall bladder helped us to grasp the
fundus. A drain was put in gall bladder bed.
Outcome measures:
Primary outcomes
1. Mortality (90-day mortality and mortality at maximal follow-up).
2. Postoperative complications: early (hemorrhage, bile leak, wound infection) and late
complications (biliary stricture)
4. Port site hernia Secondary outcomes
1. Conversion to open cholecystectomy.
2. Total hospital stay.
3. Intra-operative findings (duration of operation, intra-operative bleeding and iatrogenic
injuries)
4. Return to work.
