Outpatient Laparoscopic Cholecystectomy: Initial Results

Original Articles
Outpatient Laparoscopic Cholecystectomy:
Initial Results of a Series of 200 Cases
Francisco Martínez Ródenas, Raquel Hernández Borlán, Yaima Guerrero de la Rosa, José Moreno Solorzano,
Ana Alcaide Garriga, Edmon Pou Sanchís, Gema Torres Soberano, José María Vila Plana, Jorge Pie García,
and José Ramón Llopart López
Badalona Serveis Assistencials, Hospital Municipal, Badalona, Barcelona, Spain
Abstract
Introduction. Outpatient laparoscopic cholecystectomy
(CL) has not been generalised due to the fear of
complications by the surgeon and preference of patients
for hospitalisation. This situation could be changed by
setting up strict selection criteria and providing hospital
home care. The aims of this study are to find out what
percentage of our population fulfil these criteria, confirm
their validity and find out if the surgical process should
be improved before being introduced.
Material and method. A retrospective analysis was
carried out on the first 200 elective CL cases dating
from January 2006. The exclusion criteria were as
follows: pre-operative criteria (social causes, age ⱖ70
years, unstable ASA III or ASA IV, an associated
pathology or admission due to biliopancreatic pathology), intra-operative criteria (conversion, surgical time
lasting longer than 90 minutes, non-identification
or bleeding of the cystic artery, application of
haemostatic material, haemorrhaging in the entrance
ports, intra-abdominal bile spillage, drainage, difficulties
in removing the gallbladder, anaesthetic and/or surgical
complications) and post-operative (haemodynamic
instability, excessive pain, nausea, and /or vomiting).
Results. Out of the 200 cases, 53 (26.5%) patients
fulfilled the criteria.The outpatient system was preferred
predominantly by females and by those younger in age.
Post-operative incidents occurred in 9.4% of the cases
and these were dealt with by the hospital home care
team.
Conclusions. Ambulatory CL procedure is safe.
Patients of advanced age or with associated pathologies
Correspondence: Dr. F. Martínez Ródenas.
BSA-Hospital Municipal.
Vía Augusta, 9-13. 08911 Badalona. Barcelona. España.
E-mail: [email protected]
Manuscript received April 2, 2008; accepted for publication June
6, 2008.
262
Cir Esp. 2008;84(5):262-6
limit the inclusion. Hospital home care can solve any
possible complications and contribute to the speedy
discharge in those patients without criteria.
Key words: Cholelithiasis. Outpatient laparoscopic
cholecystectomy. Major ambulatory surgery. Hospital home
care.
COLECISTECTOMÍA LAPAROSCÓPICA
AMBULATORIA: RESULTADOS INICIALES
DE UNA SERIE DE 200 CASOS
Introducción. La colecistectomía laparoscópica
(CL) ambulatoria no se ha generalizado por temor del
cirujano a las potenciales complicaciones postoperatorias y preferencia del paciente a la hospitalización.
El establecimiento de criterios selectivos estrictos y
la hospitalización a domicilio podrían cambiar esta
predisposición. Los objetivos de este estudio son
averiguar qué porcentaje de nuestra población con
colelitiasis cumple dichos criterios, confirmar su validez y descubrir si debe mejorarse el proceso quirúrgico antes de implementarse.
Material y método. Se analizan prospectivamente
los primeros 200 casos de CL electiva desde enero
de 2006. Los criterios de exclusión son: preoperatorios (causas sociales, edad ⱖ 70 años, ASA III inestable o ASA IV, enfermedad concomitante que precisa
control hospitalario, ingreso previo por afección biliopancreática), intraoperatorios (conversión a laparotomía, tiempo quirúrgico ⱖ 90 min, sin identificación o sangrado de la arteria cística, aplicación de
material hemostático, hemorragia en puertas de entrada, vertido de bilis intraabdominal, drenajes, extracción dificultosa de vesícula, complicaciones
anestésicas y/o quirúrgicas) y postoperatorios (inestabilidad hemodinámica, dolor excesivo, náuseas y/o
vómitos en la sala de reanimación).
Resultados. Cumplieron criterios 53 (26,5%) pacientes. El sexo femenino y la menor edad favorecen
Martínez Ródenas F et al. Outpatient Laparoscopic Cholecystectomy: Initial Results of a Series of 200 Cases
el proceso ambulatorio. Se presentaron incidencias
postoperatorias en el 9,4% que podrían asumirse por
el equipo de hospitalización a domicilio.
Conclusiones. La CL en régimen ambulatorio es
segura. La edad avanzada y la enfermedad concomitante limitan la inclusión. La hospitalización a domicilio puede solucionar las posibles complicaciones y
facilitar el alta precoz de los pacientes sin criterios
de CL ambulatoria.
Palabras clave: Colelitiasis. Colecistectomía laparoscópica ambulatoria. Cirugía mayor ambulatoria. Hospitalización a domicilio.
Introduction
In the 1990s, outpatient laparoscopic cholecystectomy
(LC) safety and ability to reduce hospital costs were described
and demonstrated.1,2,3 However, despite being performed
in several hospitals in Spain,4-6 this procedure is not widelyused in this country.This is primarily because of the possibility
of postoperative complications, doubt on the part of the
surgeon of the availability of a safe backup to assume
responsibility7 and patient preference for hospitalisation.8
Because of this, the majority of cases are hospitalised for
a minimum of 1 night.9
The availability of a home care unit in our hospital, which
makes it possible to have 24-hour telephone consultation
and surgeon and nursing house calls in the first days following
surgery, provides us with the ability to evaluate the possibility
of performing this operation on a major ambulatory surgery
basis for cases that meet certain criteria. The objectives
proposed for this study have been:
– To study what percentage of our population with
symptomatic cholecystitis met the criteria for outpatient LC
– To confirm if the selection criteria were adequate
– To study the causes for exclusion among potential
candidates
– To validate the safety of outpatient LC
– To identify potential areas for improvement in case of
adverse clinical results
Material and Method
Study Design and Subjects
Prospective and observational clinical study performed between January
2006 and August 2007 at BSA-Hospital Municipal. The first 200 patients
who underwent elective LC for cholelithiasis were included. All surgeons
in the department participated in the operations.
LC was performed under balanced general anaesthesia in the French
position with a Hasson trocar and two 5 and 10 mm accessory trocars. A
fourth trocar was used for cases of difficult Calot’s triangle exposure. The
abdominal cavity was insufflated with CO2 at an intra-abdominal pressure
<14 mm Hg and gastric decompression was performed in cases of gastric
distension. Selection guidelines were used of antibiotic prophylaxis (age
>65 years, history of acute cholecystitis, pancreatitis or jaundice and bile
spillage into the abdominal cavity) and for perioperative cholangiography
(history of jaundice or pancreatitis, bilirubin or alkaline phosphatase changes
and dilation of the common bile duct >6 mm by ultrasound). The patients
were seen in outpatient surgery consultation at 1 month after discharge
and a general follow-up panel with liver function testing was performed on
those patients who had persistent symptoms.
Exclusion Criteria for Outpatient LC
The exclusion criteria have been chosen from criteria used by other
authors.1,10-15 and have been classified as preoperative, intraoperative, and
postoperative.
– Preoperative exclusion criteria: social causes (lack of family support,
lack of telephone, living far from the hospital), age ≥70 years, unstable
ASA III or ASA IV, concomitant disease that requires hospital monitoring,
obesity (body mass index ≥35) and prior admission for a biliopancreatic
condition (acute cholecystitis, pancreatitis, and obstructive jaundice)
– Intraoperative exclusion criteria: conversion to laparotomy, surgical
time >90 minutes, lack of identification of the cystic artery or haemorrhage,
use of haemostatic material in the liver bed, haemorrhage in the entrance
ports, intra-abdominal bile spillage, placement of a drain, difficult extraction
of the gallbladder through the umbilical incision, anaesthesia complications
and surgical complications
– Postoperative exclusion criteria (recovery room): haemodynamic
instability, excessive pain on the visual analogue scale (VAS) and poorly
controlled nausea and/or vomiting
The VAS quantitative model was used to evaluate postoperative pain.
It consists of a diagram with a 10 cm long horizontal line where the ends
are marked with the expressions “no pain” and “maximum pain imaginable.”
The patient marks the pain intensity on the line relative to the ends. Pain
was considered to be excessive when the distance measured from the “no
pain” end to the mark was greater than 3 cm.
Analysis of the Data
The results obtained have been analysed statistically using the
STATWIEW 512+ programme for the Macintosh personal computer. The
χ2 independence test was used for comparison of quantitative variables
and analysis of variance between qualitative and quantitative variables. A
P value less than .05 was considred significant.The results are expressed
as the median (standard deviation).
Results
Hundred forty-one women and 59 men underwent surgery,
with a median age of 57.3 (15.1) (range, 20-85) years.
Overall morbidity in the study was 8.5%. This occurred
during hospitalisation in 6 patients (1 biliary leak, 2 cases
of acute urinary retention, 2 trocar bleeds, and 1 wound
infection). One patient had a subhepatic abscess at followup that required reintervention, another had a subhepatic
collection that was treated conservatively and there were 3
wound infections. There was no mortality. The rate of
conversion to laparotomy was 5.5%. Hospital stay was 2.1
(0.9) days.
Eighty-one (40.5%) patients met the preoperative inclusion
criteria, with important differences with regards to gender
(65 women vs 16 men; P<.05) (Figure 1). Causes for
preoperative exclusion are shown in Figure 2.
The most significant criteria for intraoperative exclusion
was intra-abdominal bile spillage of any amount with or
without calculi during dissection of the gallbladder off the
liver bed, which occurred in 19 (23.5%) of the 81 patients
included. Extraction of the gallbladder through the umbilical
incision was difficult on 2 occasions in this subgroup. Of the
remaining 8 patients 2 were excluded, 3 were due to
placement of an abdominal drain, 3 due to use of haemostatic
material, 1 due to intestinal puncture, and 1 due to a surgery
time greater than 90 minutes.
Cir Esp. 2008;84(5):262-6
263
Martínez Ródenas F et al. Outpatient Laparoscopic Cholecystectomy: Initial Results of a Series of 200 Cases
Relationship Between Exclusion Criteria
for Outpatient Laparoscopic Cholecystectomya
Preoperative Criteria, %
200 Patients
Preoperative
Criteria
81 Included
40.5% (Total)
119 Excluded
Intraoperative criteria, %
Yes
No
Yes
No
76.1
37.9
23.9
62.1
a
P<.001.
Intraoperative
Criteria
54 Included
66.6% (Preoperative Criteria)
27% (Total)
27 Excluded
Postoperative
Criteria
53 Included
98.2% (Intraoperative Criteria)
26.5% (Total)
1 Excluded
Figure 1. Patient distribution according to preoperative, intraoperative,
and postoperative inclusion criteria met.
Age (≥70 Years)
8
3
21
Prior Admission
Cholecystitis
Pancreatitis
Obstructive Jaundice
11
28
10
38
Concomitant Disease
Hypertension
Diabetes
Heart Disease
Chronic Obstructive
Pulmonary Disease
Cirrhosis
Cerebral-Vascular Accident
Epilepsy
Amaurosis
Morbid Obesity
Figure 2. Exclusion criteria for 119 patients without preoperative
inclusion criteria.
There is a good correlation between the preoperative and
the intraoperative exclusion criteria (Table). In our study,
76.1% of patients who were excluded preoperatively also
met intraoperative exclusion criteria. Following the operation,
264
Cir Esp. 2008;84(5):262-6
1 patient presented abdominal pain and haemodynamic
instability during their stay in the recovery room. Therefore,
hypothetically, 53 (26.5%) patients were discharged according
to the outpatient LC programme (Figure 1).
Patients who met all the criteria for outpatient LC were
younger (43.8 [10.4] vs 62.2 [13.5] years; P<.001); the
percentage of women was greater than men’s (31.9% vs
13.6%; P<.05).
Five patients suffered incidents on the ward: vomiting (2),
pain (1), both symptoms (1), and acute urinary retention (1)
(morbidity was 1.9%). In theory, this means 9.3% of the 53
patients who were discharged suffered problems at home.
Discussion
Many authors consider LC and inguinal herniorrhaphy
to be procedures that can be performed on an outpatient
basis with better safety and efficacy.16,17 Nevertheless,
though outpatient treatment for hernia has become
common, outpatient LC is still far from common. This is
due to the fact that these procedures are not comparable.
In the case of LC, this situation is created by the risk for
potential serious postoperative complications and
uneasiness on the part of the surgeon to assume
responsibility when faced with the lack of adequate home
health services and due to legal uncertainties7,10,18,19; in
addition to patient objections who, because of uneasiness,
may assume that admission to hospital is the best option
for treatment.8 Therefore, in order to ensure successful
introduction of this project in our organisation, the following
strategy has been employed: ascertain what percentage
of the population would be affected, confirm the safety of
the procedure in order to assure our patients and surgeons
and study whether improvements should be made prior to
being carried out.
Currently, 26.5% of our reference population of patients
with symptomatic gallstones may benefit from outpatient
LC. This percentage, which may appear to be low when
compared to other studies,12-15 is the result of very stringent
selection criteria, the purpose of which, as stated above,
is to confirm the safety of outpatient LC, to avoid rejection
by patients and surgeons and to reinforce its success in
our centre. Our results are closer to those published by
Voyles et al,20 which revealed that only a third of 1750
patients evaluated in their institution met the selection
criteria.
The preoperative, intraoperative, and postoperative
selection criteria chosen in our study are sufficient because
Martínez Ródenas F et al. Outpatient Laparoscopic Cholecystectomy: Initial Results of a Series of 200 Cases
those patients who meet all of the criteria have a minimal
risk for and severity of postoperative incidents and
morbidity.
There is good correlation between the preoperative and
intraoperative causes for exclusion; a preoperative cause
for exclusion predicts that there will be an intraoperative
cause 76.1% of the time. Therefore, from a practical point
of view, the preoperative criteria are useful since they permit
sufficient selection prior to surgery.
These selection criteria may be relaxed in 2 given situations
once outpatient LC is consolidated in our centre. Half of
patients without concomitant disease and with a history of
acute pancreatitis, and the majority of patients with intraabdominal bile spillage, met the postoperative criteria and
would also have benefitted from the outpatient procedure.
As with our findings, a recent study14 indicates that gallbladder
perforation is not an intraoperative factor that predicts failure
of the outpatient protocol.
Apart from 1 patient who suffered urinary retention, the
other postoperative incidents were related to pain, nausea,
and/or vomiting. Before initiating the programme, establishing
an analgesic and antiemetic protocol is a top priority in order
to improve the quality of our results and to avoid the
occurrence of these problems in the patient’s home.
Postoperative nausea and vomiting are the main cause of
unexpected hospital admission, which varies by study15,21
between 1% and 39%. Poorly-controlled postoperative pain,
conversion to laparotomy and uneasiness on the part of the
patient also contribute.15 The rate of readmission varies from
1.9% to 8% and is related to morbidity21; in which residual
bile duct lithiasis is an important cause.
Some authors have questioned the safety of outpatient
cholecystectomy treatment.22,23 Nevertheless, some
studies24,25 have shown that, with regards to vital
complications (1/2000 LC), these become symptomatic
within the first hours following surgery, so they would be
detected during hospitalisation, and other complications,
such as injury to the bile duct (0.3%-1%), are not usually
discovered until the second day following surgery; as such,
a 4-6 hour observation period would be prudent since hospital
admission would not reduce detection of later major
complications.15
After confirming the incidences of postoperative morbidity
of the candidates who met the selection criteria, it can be
stated that outpatient LC is a safe procedure in our area
and that the minimal complications, should they appear, can
be evaluated and resolved effectively by our home health
team.This team may also facilitate early discharge for patients
who did not meet the criteria needed for outpatient LC.
Our results reveal that female gender and lower age are
factors that facilitate outpatient LC. These results coincide
with the findings reported by Lau et al.12
The success of a major ambulatory surgery programme
depends on the effort and coordination between surgeons,
anaesthesiologists and nursing staff. Sufficient information
to the patient is fundamental in order to gain their trust
and acceptance, as is understanding their opinion.26 There
is no doubt that all of the activities developed in order
to establish a major ambulatory surgery programme will
result in an improvement in quality of care in addition to
providing an economic benefit to the healthcare
system.8,14,27,28
References
1. Reddick EJ, Olsen DO. Outpatient laparoscopic laser cholecystectomy.
Am J Surg. 1990;160:485-7.
2. Arregui ME, Davis CJ, Arkush A, et al. In selected patients outpatient
laparoscopic cholecystectomy is safe and significantly reduces
hospitalization charges. Surg Laparosc Endosc. 1991;1:240-5.
3. Zegarra RF 2nd, Saba AK, Peschiera JL. Outpatient laparoscopic
cholecystectomy: safe and cost effective? Surg Laparosc Endosc.
1997;7:487-90.
4. Pardo J, Ramia R, Martín JM, López A, Padilla D, Cubo T, et al.
Colecistectomía laparoscópica ambulatoria. Cir Esp. 1998;64:37-9.
5. Serralta A, García R, Martínez P, Hoyas L, Planells M. Cuatro años
de experiencia en colecistectomía laparoscópica ambulatoria. Rev
Esp Enferm Dig. 2001;93:207-10.
6. Bermúdez I, López S, Sanmillán A, González C, Baamonde de la
Torre I, Rodríguez A, et al. Colecistectomía laparoscópica en régimen
ambularorio. Cir Esp. 2004;76:159-63.
7. Henderson J, Goldacre MJ, Griffith M, Simmons HM. Day-case surgery:
geographical variation, trends, and readmissions rates. J Epidemiol
Community Health. 1978;43:301-5.
8. Planells M, Sánchez A, Sanahuja A, Bueno J, Serralta A, García R,
et al. Gestión de la calidad toral en colecistectomía laparoscópica.
Calidad asistencial y calidad percibida en colecistectomía laparoscópica
ambulatoria. Rev Esp Enferm Dig. 2002;94:319-25.
9. Turienzo EO, Rodríguez JI, Trelles A, Aza J. Gestión integral del
proceso de colecistectomía laparoscópica. Cir Esp. 2006;80:
385-94.
10. Fiorillo M, Davidson P, Fiorillo M, D’Anna J, Sithian N, Silich R. 149
ambulatory laparoscopic cholecystectomies. Surg Endosc. 1996;10:
52-6.
11. Cuschieri A. Day-case (ambulatory) laparoscopic surgery: let us sing
from the same hymn sheet. Surg Endosc. 1997;11:1143-4.
12. Lau H, Brooks DC. Transitions in laparoscopic cholecystectomy. The
impact of ambulatory surgery. Surg Endosc. 2002;16:323-6.
13. Martínez A, Docobo F, Mena J, Durán I, Vázquez J, López F, et al.
Colecistectomía laparoscópica en el tratamiento de la litiasis biliar:
¿cirugía mayor ambulatoria o corta estancia? Rev Esp Enferm Dig.
2004;96:452-9.
14. Bueno J, Planells M, Sanahuja A, García R, Arnau C, Guillemot M.
Factores intraoperatorios predictivos del fracaso del régimen ambulatorio
tras colecistectomía laparoscópica. Cir Esp. 2005;78:168-74.
15. Bueno J, Planells M, Arnau C, Sanahuja A, Oviedo M, García R, et
al. Colecistectomía laparoscópica ambulatoria. ¿El nuevo “gold
standard” de la colecistectomía? Rev Esp Enferm Dig. 2006;98:
14-24.
16. Campanelli G, Cavagnoli R, Cioffi U, de Simona M, Fabián M, Pietro
P. Can laparoscopic cholecystectomy be a day surgery procedure.
Hepatogastroenterology. 1998;45:1422-9.
17. Keulemans Y, Eshuis J, de Haes H, de Wit L, Gonma DI. Laparoscopic
cholecystectomy: day-care versus clinical observation. Ann Surg.
1998;228:730-40.
18. Saunders CJ, Leary BF, Wolfe BM. Is outpatient laparoscopic
cholecystectomy wise? Surg Endosc. 1997;11:1147-9.
19. Joshi GP, Twersky R. Fast tracking in ambulatory surgery. Amb Surg.
2000;8:185-90.
20. Voyles CR, Berch BR. Selection criteria for laparoscopic
cholecystectomy in an ambulatory care setting. Surg Endosc. 1997;
11:1145-6.
21. Lau H, Brooks DC. Contemporary outcomes of ambulatory laparoscopic
cholecystectomy in a major teaching hospital. World J Surg.
2002;26:1117-21.
22. Llorente J. Laparoscopic cholecystectomy in the ambulatory surgery
setting. J Laparoendosc Surg. 1992;2:23-6.
23. Saunders C, Learvy B, Wolfe B. Is outpatient laparoscopic
choleystectomy wise? Surg Endosc. 1995;9:1263-8.
24. Deziel D, Millikan K, Economou S, Doolas A, Ko S, Airan M.
Complications of laparosocpic cholecystectomy: a nacional survey of
4,929 hospitals anda n análisis of 77,604 cases. Am J Surg. 1993;165:
9-14.
25. Richarson M, Bell G, Fullarton G. Incidente and nature of bile Duch
injuries following laparosocpic cholecystectomy: an audit of 5913
cases.West of Scotland Laparoscopic Cholecystectomy Audit Group.
Br J Surg. 1996;83:1356-60.
26. Codina J, Martínez-Ródenas F, Utrera C, Díaz L, Sánchez P, Pié P.
La opinión del paciente en cirugía mayor ambulatoria y su inclusión
como parámetro de calidad. Cir Esp. 1998;64:28-32.
Cir Esp. 2008;84(5):262-6
265
Martínez Ródenas F et al. Outpatient Laparoscopic Cholecystectomy: Initial Results of a Series of 200 Cases
27. Keulemans Y, Eshuis J, de Haes H, De Wit LT, Gouma DJ. Laparoscopic
cholecystectomy: day care versus clinical observation. Ann Surg.
1998;228:734-40.
266
Cir Esp. 2008;84(5):262-6
28. Lillemoe KD, Lin JW, Talamini MA, Yeo CJ, Synder DS, Parker SD.
Laparoscopic cholecystectomy as a “true” outpatient procedure: initial
experience in 130 consecutive patients. J Gastrointest Surg. 1999;3:44-9.