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“ common bile duct exploration ”, “ laparoscopic common bile duct exploration ”,
“ open common bile duct exploration”, “ choledocholithiasis ”, “transcholedochal”
AND “T-tube”, “biliary drainage”, “tube drainage”, “primary closure”, “ choledochotomy closure ”. Trials comparing primary closure and T-tube drainage after transcholedochal CBDE (both open and laparoscopic) were included in the subsequent
analysis.
Results
Six randomized trials including a total of 359 patients have compared the strategies
of primary closure versus T-tube drainage after open CBDE [ 5 – 10 ]. Four such trials
with 399 total patients have been performed for laparoscopic CBDE [ 11 – 14 ].
Additionally two Cochrane Group meta-analyses have been performed which
aggregated and analyzed these studies (one for open CBDE [ 15 ] and one for laparo-
scopic [ 16 ]). The existing literature mostly examines perioperative and short-term
postoperative outcomes , such as operative time, 30-day postoperative morbidity and
mortality , hospital length of stay, and need for re-interventions during the immediate postoperative period. Long-term implications of using or foregoing T-tube
drainage have not been as well studied. The following sections discuss the available
evidence with respect to specifi c outcomes after both open and laparoscopic
CBDE. Tables 18.2 and 18.3 summarize these quantitative comparison data com-
paring primary closure to T-tube drainage for open and laparoscopic CBDE
respectively.
Operative Time
Placement of a T-tube after CBDE, whether open or laparoscopic , requires several
discrete steps: the limbs of the t-tube are fashioned into the proper lengths and confi guration, the tube is inserted into the common ductotomy, the ductotomy is partially sutured closed so that the T-tube is secured in position but not so tightly that it
cannot eventually be removed, and the external portion of the tube must be brought
Table 18.1 PICO terms used in defi ning the clinical question and search strategy
P (Patients) I (Intervention) C (Comparator) O (Outcomes)
Patients with
choledocholithiasis
treated with open or
laparoscopic
transcholedochal
common bile duct
exploration (CBDE)
Primary closure of
the choledochotomy
at the conclusion of
CBDE
T-tube placement
through the
choledochotomy for
postoperative biliary
drainage at the
conclusion of CBDE
Operative time,
mortality, serious
morbidity, hospital
length of stay,
recurrent
choledocholithiasis,
biliary stricture
E.N. Teitelbaum et al.
213
out through to the skin. This is opposed to the strategy of primary closure, during
which the common ductotomy is simply sutured closed in order to conclude the
procedure.
Accordingly, it seems intuitive that primary closure should result in shorter operative times, and this appears to have been borne out in the randomized studies that
have compared the two approaches for both laparoscopic and open CBDE. Of the
randomized trails performed for open CBDE, only one compared operative times,
and found primary closure to be faster by 28 min [ 5 ]. The evidence for laparoscopic
CBDE is more robust, with all four randomized trials comparing operative times.
All of these studies demonstrated shorter operative times in their primary closure
patients, with similar mean differences between the groups ranging from 17 to
26 min [ 11 – 14 ].
Perioperative Mortality and Morbidity
When performed in experienced hands, both open and laparoscopic CBDE carry a
very low risk of perioperative mortality . As such, it is not surprising that even when
the results of all randomized trials are aggregated, there are no differences in mortality between primary closure and T-tube drainage. In studies of open CBDE the
aggregate perioperative mortality with t-tube drainage was 1.2 %, as opposed to
0.6 % with primary closure [ 15 ], and this difference was not statistically signifi cant.
In the four randomized trials comparing these techniques for laparoscopic CBDE,
there were no perioperative deaths among the 399 patients, which speaks to both the
safety and physiologic benefi ts of a laparoscopic approach.
Serious morbidity has also not been conclusively shown to differ between primary ductotomy closure and T-tube drainage, although there may be an advantage
Table 18.2 Comparison of
compiled data from
randomized trials comparing
primary closure versus T-tube
drainage for open CBDE [
15 ]
Outcomes
Primary
closure
T-tube
drainage
Operative time (mins) 88* 117
Mortality (%) 0.6 1.2
Serious morbidity (%) 6.6 14.5
Hospital stay (days) 9.1* 13.8
*p < 0.05 in favor of primary closure
Table 18.3 Comparison of
compiled data from
randomized trials comparing
primary closure versus T-tube
drainage for laparoscopic
CBDE [
16 ]
Outcomes
Primary
closure
T-tube
drainage
Operative time (mins) 106* 127
Mortality (%) 0 0
Serious morbidity (%) 6.1 9.7
Hospital stay (days) 3.9* 7.2
*p < 0.05 in favor of primary closure
18 Primary Closure or T-Tube Drainage After Open or Laparoscopic Common Bile...
214
to primary closure in this regard. A meta-analysis of trials comparing the approaches
after open CBDE, found a serious morbidity rate of 14.5 % after T-tube drainage, as
opposed to 6.6 % after primary closure, although this difference narrowly missed
obtaining statistical signifi cance. Similarly, when the trials comparing the
approaches during laparoscopic CBDE were analyzed, the overall serious complication rate was 11.3 % in the T-tube group versus 6.1 % in the primary closure
patients; however, this difference was also not statistically signifi cant.
A closer examination of the results of these trials reveals that a number of these
serious complications were directly related to use of the T-tube , and thus these trials
may simply not be adequately powered to detect the added risk that T-tube placement confers (i.e., a Type II statistical error is present). For example, patients in
several trials required reoperation for replacement of prematurely dislodged T-tubes,
in some cases leading to bile peritonitis. Also, bile leak age after T-tube removal
occurred in approximately 1–2 % of patients, which usually required either replacement of another tube through the existing tract, percutaneous drainage of a bile
collection, or reoperation for drainage and tube replacement. This is in contrast to
the primary closure group, in which bile leakage from the choledochotomy closure
occurred in less than 1 % of patients, and could almost uniformly be treated with
ERCP sphincterotomy and/or stenting without the need for reoperation [ 15 ].
Therefore, even when a “serious morbidity ” occurs after CBDE with primary closure, it appears to result in less severe consequences for the patient when contrasted
with complications directly related to the use of a T-tube.
Hospital Length of Stay
The use of a T-tube adds another clinical variable, as the drain outputs must be
tracked, the decision to place the tube to drainage versus clamping is weighed, and
routine and/or clinically-prompted T-tube cholangiograms are often obtained in
order to evaluate for biliary obstruction and/or leakage. Additionally, patients must
be educated regarding the self-care and management of the tube at home prior to
leaving the hospital. All of these factors can potentially lead to longer hospital
length of stay in the perioperative period, and this has been refl ected in the literature
examining both open and laparoscopic CBDE. In trials comparing approaches for
open CBDE, primary closure resulted in a marked advantage over T-tube drainage,
with a mean difference in hospital length of stay of 4.7 days [ 15 ]. This superiority
of primary closure was also present to a lesser extent in the trials involving laparoscopic CBDE, with a mean difference of 3.3 days. The smaller difference in length
of stay after laparoscopic CBDE is likely due to the overall decreased length of stay
after laparoscopic, when compared with open, surgery then to a less signifi cant
advantage of primary closure over t-tube drainage. Additionally, one study compared time to return to work, and found patients undergoing primary closure did so
8 days earlier than those with T-tubes [
13 ].
E.N. Teitelbaum et al.
215
Long-Term Outcomes
Most trials have focused on perioperative outcomes when comparing the strategies
of primary closure and T-tube drainage after CBDE, but some longer-term outcomes data does exist. One of the theoretical reasons behind the use of a T-tube is
to facilitate biliary access in the case of retained stones and/or prevent biliary stricture . However, in the limited outcomes data available, neither of these potential
complications appear to be either frequent or lessened in severity by the use of
T-tube drainage at the time of initial CBDE. In experienced hands, the rate of a
retained common duct stones is less than 5 % for both open and laparoscopic
CBDE. Additionally, missed stones are usually small, and thus are almost universally retrievable via ERCP , obviating the need for T-tube access to the biliary system
in the rare instance that they do occur. In the three open and one laparoscopic trials
that evaluated longer-term outcomes at 6-months to 2.5 years, no patients in either
arm (primary closure or t-tube drainage) had either recurrence of choledocholithiasis or new-onset of biliary stricture [ 5 , 6 , 10 , 11 ]. There are no studies examining
outcomes beyond 2.5 years.
Recommendations Based on the Data
1. Primary choledochotomy closure after CBDE (both open and laparoscopic )
results in shorter operative times and shorter hospital length of stay when com-
pared with t-tube drainage – HIGH level of evidence
2. Primary closure and t-tube drainage after CBDE result in equivalent rates of seri-
ous complications in the perioperative period – MODERATE level of evidence
3. Primary closure and t-tube drainage after CBDE result in equivalent rates of
long-term recurrent choledocholithiasis and biliary stricture – VERY LOW level
of evidence
4. Primary choledochotomy closure should be the preferred technique in uncompli-
cated cases of both open and laparoscopic CBDE – MODERATE strength
recommendation
Potential Exceptions to Recommendations
As with any surgical disease and operation, each patient undergoing CBDE for choledocholithiasis must be evaluated individually, and various factors must be taken
into account when determining the most benefi cial approach to their condition. That
is to say, despite our moderate strength recommendation of the use of primary closure, there are many instances in which T-tube drainage might be the superior option
for a given patient. For example, if a completion cholangiogram at the conclusion of
18 Primary Closure or T-Tube Drainage After Open or Laparoscopic Common Bile...
216
a CBDE procedure demonstrates poor fl ow of contrast into the duodenum despite an
absence of stones in the common bile duct , edema or stricture at the Ampulla of
Vater may be present. In this case, placing a T-tube would be the best option, as both
drainage and instrumentation of the biliary system will likely be necessary in the
immediate postoperative period. Alternatively, if a patient undergoing CBDE has a
prior Roux-en-Y gastric bypass that precludes future ERCP , the safest option may
be to place a T-tube, so that the biliary system can be accessed easily in the case of
a retained stone or bile leak age. Finally, the lack of data regarding the incidence of
biliary stricture beyond 2.5 years should also be taken into account when making
the decision for or against T-tube placement at the time of CBDE.
Utilization of CBDE and Future Directions for Training
While it is important to study technical considerations such as T-tube drainage versus primary closure, CBDE still remains an extremely underutilized method for
treating common bile duct stones. This remains true despite the advantages of
CBDE (particularly laparoscopic CBDE) compared to ERCP [ 3 , 4 ]. For example, a
study examining data from the United States National Inpatient Sample found that
of patients admitted to hospitals with a diagnosis of choledocholithiais, 93 % were
treated with ERCP as opposed to 7 % with CBDE [ 17 ].
Several reasons likely exist for this disparity including: lack of CBDE instrument
availability, lack of familiarity with the procedure on the part of surgeons and support staff, and relatively poor fi nancial reimbursement for surgeons. The lack of
exposure to, and training in, CBDE during surgical residency is almost certainly a
central barrier to more widespread adoption of CBDE for treatment of choledocholithiasis . A review of residents’ operative case logs showed that graduating chief
residents had performed a mean of 1.7 open and 0.7 laparoscopic CBDE procedures
during their entire residency, with a mode of 1 and 0 respectively [ 18 ]. This limited
experience is not suffi cient for gaining competency with either primary choledochotomy closure or T-tube placement, let alone the remainder of the skills required
to perform CBDE.
In order to address this lack of exposure to CBDE during residency and hopefully increase the utilization of procedure at our institution, we have developed a
laparoscopic CBDE simulator for training and evaluation purposes [ 19 ]. The simu-
lator recreates the three visualization modalities involved in the operation (laparoscopic, endoscopic , and fl uoroscopic), and trainees are able to perform a complete
simulated procedure via either a transcystic or transcholedochal approach. We have
been able to demonstrate that a technical curriculum based around practice on the
simulator is able to consistently train senior surgery residents to the level of a predetermined “mastery standard” over the course of a two-month rotation [ 20 ].
Hopefully, similar training initiates can be developed nationally, with the goal of
increasing the utilization of CBDE and ultimately improving patient outcomes . If
CBDE becomes more commonly used by surgeons for the treatment of choledocho-
E.N. Teitelbaum et al.
217
lithisis, the question of whether to perform a primary choledochotomy closure or
leave a T-tube for biliary drainage will become even more clinically relevant and
important.
References
1. Houdart R, Perniceni T, Darne B, Salmeron M, Simon JF. Predicting common bile duct lithia-
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1995;170:38–43.
2. Collins C, Maguire D, Ireland A, Fitzgerald E, O’Sullivan GC. A prospective study of common
bile duct calculi in patients undergoing laparoscopic cholecystectomy: natural history of choledocholithiasis revisited. Ann Surg. 2004;239:28–33.
3. Cuschieri A, Lezoche E, Morino M, et al. E.A.E.S. multicenter prospective randomized trial
comparing two-stage vs single-stage management of patients with gallstone disease and ductal
calculi. Surg Endosc. 1999;13:952–7.
4. Rogers SJ, Cello JP, Horn JK, et al. Prospective randomized trial of LC+LCBDE vs ERCP/
S+LC for common bile duct stone disease. Arch Surg. 2010;145:28–33.
5. Marwah S, Singh I, Godara R, Sen J, Marwah N, Karwasra RK. Evaluation of primary duct
closure vs T-tube drainage following choledochotomy. Indian J Gastroenterol.
2004;23:227–8.
6. Ambreen M, Shaikh AR, Jamal A, Qureshi JN, Dalwani AG, Memon MM. Primary closure
versus T-tube drainage after open choledochotomy. Asian J Surg/Asian Surg Assoc.
2009;32:21–5.
7. Lygidakis NJ. Choledochotomy for biliary lithiasis: T-tube drainage or primary closure.
Effects on postoperative bacteremia and T-tube bile infection. Am J Surg. 1983;146:254–6.
8. Makinen AM, Matikainen M, Nordback I. T-tube drainage is needed after routine common bile
duct closure: results of a randomized trial. Surg Res Commun. 1989;6:299–302.
9. Payne RA, Woods WG. Primary suture or T-tube drainage after choledochotomy. Ann R Coll
Surg Engl. 1986;68:196–8.
10. Williams JA, Treacy PJ, Sidey P, Worthley CS, Townsend NC, Russell EA. Primary duct clo-
sure versus T-tube drainage following exploration of the common bile duct. Aust N Z J Surg.
1994;64:823–6.
11. Dong ZT, Wu GZ, Luo KL, Li JM. Primary closure after laparoscopic common bile duct
exploration versus T-tube. J Surg Res. 2014;189:249–54.
12. Zhang WJ, Xu GF, Wu GZ, Li JM, Dong ZT, Mo XD. Laparoscopic exploration of common
bile duct with primary closure versus T-tube drainage: a randomized clinical trial. J Surg Res.
2009;157:e1–5.
13. Leida Z, Ping B, Shuguang W, Yu H. A randomized comparison of primary closure and T-tube
drainage of the common bile duct after laparoscopic choledochotomy. Surg Endosc.
2008;22:1595–600.
14. El-Geidie AA. Is the use of T-tube necessary after laparoscopic choledochotomy? J Gastrointest
Surg. 2010;14:844–8.
15. Gurusamy KS, Koti R, Davidson BR. T-tube drainage versus primary closure after open com-
mon bile duct exploration. Cochrane Database Syst Rev. 2013;6, CD005640.
16. Gurusamy KS, Koti R, Davidson BR. T-tube drainage versus primary closure after laparo-
scopic common bile duct exploration. Cochrane Database Syst Rev. 2013;6, CD005641.
17. Poulose BK, Arbogast PG, Holzman MD. National analysis of in-hospital resource utilization
in choledocholithiasis management using propensity scores. Surg Endosc. 2006;20:186–90.
18. Helling TS, Khandelwal A. The challenges of resident training in complex hepatic, pancreatic,
and biliary procedures. J Gastrointest Surg. 2008;12:153–8.
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19. Santos BF, Reif TJ, Soper NJ, Nagle AP, Rooney DM, Hungness ES. Development and evalu-
ation of a laparoscopic common bile duct exploration simulator and procedural rating scale.
Surg Endosc. 2012;26:2403–15.
20. Teitelbaum EN, Soper NJ, Santos BF, et al. A simulator-based resident curriculum for laparo-
scopic common bile duct exploration. Surgery. 2014;156:880–7, 90–3.
21. O’Toole MT, editor. Miller-Keane encyclopedia and dictionary of medicine, nursing and allied
health. 7th ed. Philadelphia: Saunders; 2003.
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219© Springer International Publishing Switzerland 2016
J.M. Millis, J.B. Matthews (eds.), Diffi cult Decisions in Hepatobiliary
and Pancreatic Surgery, Diffi cult Decisions in Surgery: An Evidence-Based
Approach, DOI 10.1007/978-3-319-27365-5_19
Chapter 19
Single-Incision or Multiport Laparoscopic
Cholecystectomy
Bill Ran Luo and Nathaniel J. Soper
Abstract This chapter reviews the current body of literature comparing multi-port
laparoscopic cholecystectomy versus single incision laparoscopic cholecystectomy;
specifi cally differences between complications, conversion rates, pain, cosmesis,
quality of life, cost, and rate of hernia formation.
Keywords Laparoscopic cholecystectomy • Single-incision • Multi-port •
Morbidity • Pain • Cosmesis • Cost
Introduction
Laparoscopic cholecystectomy is one of the most common operations performed in
the western world today. The standard of care for gallbladder removal prior to the
1980s was an open cholecystectomy , but with the acceptance of laparoscopic cholecystectomy as a standard technique in the 1990s, the world of minimally invasive
surgery for gallbladder pathology expanded [ 2 ]. After an initial learning curve,
laparoscopic cholecystectomy was demonstrated to have an overall complication
rate of less than 5 % with an established rate of common bile duct injury between
0.3 and 0.5 % [ 1 ]. Given the drive for surgeons to continue to innovate and create
less invasive surgical techniques, single incision laparoscopic cholecystectomies
have developed a large base of support. However, as standard multi-port laparoscopic cholecystectomy (MPLC) has such proven and safe results, single incision
cholecystectomy naturally must be analyzed and dissected critically, to ensure that
outcomes are cost effective, effi cient, and, most importantly, safe for patients. These
single incision approaches have multiple eponyms; including single incision
B. R. Luo • N. J. Soper (*)
Department of Surgery , Northwestern Medicine ,
251 E. Huron St. Galter 3-150 , Chicago , IL 60611 , USA
e-mail:
nsoper@nmh.org
220
laparoscopic surgery (SILS), single port access (SPA), and laparo- endoscopic single site (LESS). In this chapter, we will abbreviate the single-incision laparoscopic
cholecystectomy as SILC.
Search Strategy
A literature search of English language publications from 2000 to 2014 was used to
identify published data on single incision and multi-port laparoscopic cholecystectomy comparative results in the adult population using the PICO outline. Databases
searched were PubMed, Embase, Science Citation Index/Social sciences Citation
Index and Cochrane Evidence Based Medicine . Terms used in the search were “single incision cholecystectomy ”, “SILS” “single access cholecystectomy”, “SPA”,
“single port cholecystectomy”, “laparoendoscopic single site cholecystectomy”,
“LESS”, “multi-port laparoscopic cholecystectomy”, “standard laparoscopic cholecystectomy”, “conventional cholecystectomy”, “conventional laparoscopic cholecystectomy” AND “ cost ” OR “ pain ” OR “ morbidity ” OR “ mortality ” OR
“conversion” OR “conversion rate” OR “effectiveness” OR “operative time” OR
“ cosmesis ” OR “hernia” OR “hernia rates” OR “complications” OR “admission”
OR “re-admission” OR “ outcomes ” OR “randomized trials” OR “randomised trials” OR “prospective trials”. Articles were excluded if they exclusively addressed
open cholecystectomy, natural orifi ce (NOTES) cholecystectomy, robotic cholecystectomy, or pediatric patients. Ten randomized controlled trials, 11 retrospective
studies, and 6 systematic reviews were included in our analysis. The data were classifi ed using the GRADE system.
Results of Single Incision Laparoscopic Cholecystectomy Compared with Standard Multi-port Laparoscopic Cholecystectomy
Peri-operative Morbidity and Mortality
Laparoscopic cholecystectomy has evolved to be an operation that is safe for
patients for both acute cholecystitis and in the elective setting, with low morbidity
(3.1 %) and mortality (0.3 %) [ 1 ]. There have been no reported mortalities following
SILC in any published studies [ 3–7, 10 – 25 , 27 , 30 ]. With analysis of all adverse
events, the data favored MPLC, with an odds ratio of 1.14 (0.69–1.91) [ 27 ]. One
meta-analysis that stratifi ed expertise bias showed a difference in complications for
SILC (5.35 %) versus conventional (3.79) in non-expert hands [ 31 ]. However, other
B.R. Luo and N.J. Soper
221
studies showed either no difference or an improved overall complication rate for
SILC [ 20 , 30 ]. There were no differences for major biliary complications, which for
SILC ranged from 0.3 to 0.5 % [ 8 , 15 , 28, 29, 31 ]. Bleeding risks appear to be
equivalent between the two techniques, about 1 % in these studies [ 16 , 20 , 26 ], with
one study showing a minimal favorability toward MPLC [ 27 ]. Periumbilical port
site infections for SILC trended higher in some studies, but failed to reach statistical
signifi cance [ 20 , 26 ]. Based on the available randomized trials and meta -
analyses – there is high level evidence that there is no difference in mortality ,
major complications , or biliary complications ( Grade 1A recommendation that
either SILC or MPLC are safe approaches ), but there is low level evidence
which suggests that there may be a small increase in adverse events and port
site infections in SILC patients ( Grade 2C recommendation in favor of MPLC ).
Conversion Rates
There were no differences between conventional and SILC in conversion rates to a
laparotomy, with rates as low as 0.2 % [ 26 , 31 ]. More likely is the conversion from
SILC to MPLC, with variable rates of 0.2 % up to 8 %, but these conversions were
proven to be safe in multiple studies [ 24 , 27 , 30 ]. There is high level evidence that
conversion from SILC to MPLC is safe , as well as high level evidence that rates
of conversion to a laparotomy for both procedures are negligible and comparable in the elective setting . ( Grade 1A recommendation that either SILC or
MPLC are safe modalities ).
Cost
One of the largest prospective randomized trials comparing MPLC and SILC found
signifi cant increases in charges for SILC, specifi cally increased total hospital
charges of $2,100, surgical equipment $1,700, operating room costs $913, and anesthesia costs $241 [ 19 ]. There were no differences in pharmacy, laboratory, recovery
room, observation or ICU costs. These increases in costs were consistently higher
for SILC in several other studies, although the increased costs ranged from $400 to
964 with some variability in signifi cance [ 9 , 12 , 26 ]. Only one retrospective study
analyzed cost , showing a slight increase in SILC patients, but only those that converted to MPLC. The rest of the large prospective randomized trials did not analyze
the cost differences between the two. There is moderate level evidence that SILC
incurs more hospital costs when compared with MPLC . ( Grade 1B recommendation in favor of MPLC .)
19 Single-Incision or Multiport Laparoscopic Cholecystectomy