Surgical Endoscopy

, Volume 24, Issue 9, pp 2241–2247

Single-incision laparoscopic cholecystectomy is feasible: initial experience with 80 cases

Authors

  • Alan Bradshaw
  • Paul Ahearne
  • Pierre Dematos
  • Ted Humble
  • Randy Johnson
  • David Mauterer
  • Peeter Soosaar
Article

DOI: 10.1007/s00464-010-0943-z

Cite this article as:
Edwards, C., Bradshaw, A., Ahearne, P. et al. Surg Endosc (2010) 24: 2241. doi:10.1007/s00464-010-0943-z

Abstract

Background and objective

Single-incision laparoscopic surgery (SILS) is a new advance wherein laparoscopic surgery is carried out through a single small incision hidden in the umbilicus. Advantages of this technique over standard laparoscopy are still under investigation. The objective of this study is to describe the short-term outcomes of SILS cholecystectomy in a single community-based institution.

Methods

A retrospective review of a prospectively collected database for all patients who underwent SILS cholecystectomy was carried out. Both true single-incision and dual-incision (training) cases were included in the analysis. Operative and perioperative outcomes were analyzed.

Results

Eighty SILS cholecystectomies (4 dual incision and 76 single incision) were performed from May 30, 2008 to April 23, 2009 (indications: 48 stones, 20 cholecystitis, 11 biliary dyskinesia, and 1 polyp). Mean body mass index (BMI) was 26.5 kg/m2 (range 17.3–39.1 kg/m2), mean operating room (OR) time was 69.5 min (range 29–126 min), mean estimated blood loss (EBL) was 5 cc, and mean incision length was 1.6 cm. There were no open conversions, but there were six conversions to dual-port and three conversions to four-port laparoscopic cholecystectomy due to poor visualization. Complications include three bile leaks managed with endoscopic retrograde cholangiopancreatography (ERCP) and percutaneous drainage (3.7%). Two leaks were from accessory ducts and one was from a cystic duct stump. Number of days of postoperative oral narcotic use was described as none in 11 patients (23%), minimal (1 day) in 21 patients (45%), moderate (1–3 days) in 6 patients (13%), and heavy (≥4 days) in 9 patients (19%), with mean follow-up of 4.7 months in 60 patients.

Conclusion

SILS cholecystectomy is feasible, with acceptable morbidity. Although not directly compared in this study, postoperative recovery appears shorter than after standard laparoscopy, but more studies are needed.

Keywords

Single-incision laparoscopic surgery (SILS)Single-port access surgeryCholecystectomySingle incision

The advent of laparoscopy in the 1980s has made laparoscopic cholecystectomy one of the most common procedures in general surgery, with improved overall recovery and shortened length of hospital stay compared with conventional open cholecystectomy. Today, laparoscopic cholecystectomy is a simple outpatient procedure with little complication and relatively little loss of normal activity. Although it is hard to improve on laparoscopic cholecystectomy, the arrival of single-incision or single-port access surgery may allow this.

Single-incision laparoscopic surgery has been performed for simple gynecological procedures such as tubal ligation for years now. This concept is now being applied to other areas of surgery and has been described for urological, general, and bariatric surgery. Single-port cholecystectomy emerged from the use of “fewer-port” cholecystectomy, where two or three ports were used to perform traditional four-port cholecystectomy. Single-port access surgery is the natural evolution of this reduced port concept for cholecystectomy. The first transumbilical cholecystectomies were described in 1999 [1, 2]. Since then other surgeons have advanced this technique, which goes by many names, such as SILS, single-port access (SPA), single laparoscopic incision transabdominal (SLIT) surgery, etc. [24]. To date, however, little has been formally published regarding single-incision cholecystectomy.

The advantages of single-incision laparoscopic cholecystectomy are not yet clearly defined. Decreased postoperative pain, faster return to normal activity, and improved cosmetic outcome are a few of the proposed advantages over traditional laparoscopy but have yet to be compared prospectively. The meteoric rise in popularity of this technique so far has been largely driven by industry and supposed patient demand, without true safety and efficacy studies by advanced minimally invasive surgeons. The possible safety concerns regarding this technique are related to the possible decreased visualization or exposure offered by this technique. Larger fascial incisions and subsequent risk of incisional hernia are also a concern. To date, no large safety and feasibility trials have been published.

The authors began using this technique in early March 2008, when this technique was still in its infancy. The possible patient demand for this new technology largely drove the decision to trial this technique, but safety concerns were high. There was also concern that the increase in operative time may make this technique prohibitive in the heavy-volume community setting. The purpose of this series is to describe the safety and feasibility of single-incision laparoscopic cholecystectomy in a high-volume community hospital.

Patients and methods

A retrospective chart review of a prospectively collected database from March 2008 to April of 2009 was conducted. Hospital records from a large community tertiary referral center as well as office records of a single community practice were reviewed. Seven surgeons’ experience from a single group was included in this analysis. With some surgeons, the first few cases were performed using a two-incision technique in an effort to ease into the single-incision technique, and these were included in the analysis as well. Conversions to more traditional laparoscopic or open cholecystectomy were also included and labeled as conversions.

Operative morbidity is the primary outcome measure for this study. Secondary outcome measures include operative time, blood loss, and use of postoperative narcotics. Morbidity was evaluated by rates of bile leak, wound infection, hospital readmission, and hernia. Postoperative narcotic use was extracted from patients’ account of their use of oral narcotics after surgery when interviewed 1–2 weeks after surgery in the outpatient setting. Postoperative narcotic use was categorized as: none, if no narcotics were used; minimal, if used for only 1 day after; moderate if used for 2–3 days after surgery; and heavy, if used for more than 4 days. A visual analog scale for pain was not used in this series due to the limitations of the retrospective review. It was also felt that truly accurate visual analog pain scores would not be possible 2–3 weeks postoperatively in an outpatient private-practice setting, as patients would be subjected to recall bias. Therefore the use of postoperative narcotics, while still biased, is intended to provide some indication of postoperative pain. Data was analyzed using basic statistical analysis based on mean and range. It was felt that patient selection bias would make true comparison with traditional laparoscopy difficult and this was therefore not included in this phase of the study. This will be included in further reviews as the series progresses in the future.

The technique for single-incision laparoscopic cholecystectomy has changed during the course of this series. As training cases, a dual-incision technique was used, consisting of a single umbilical incision with two ports placed via separate fascial stab incisions for the camera and a second incision made for the operative hand in the upper midline. Transabdominal suture retractors were used, as described below. Once the surgeon was comfortable with the use of suture retractors, the second incision was abandoned and a true single-incision technique was used. The typical training period was 0–2 cases per surgeon with the dual-incision laparoscopic surgical (DILS) technique.

Two different access techniques were used during this series for true single-incision surgery. Initially, a single-incision multifascial puncture technique was used for the first cases by the primary author. This consisted of a single 1.5-cm umbilical skin incision followed by placement of a Veress needle to insufflate the abdomen. Care was taken not to elevate skin flaps due to concern over poor postoperative cosmetic outcome secondary to seroma formation. A 5-mm optical trocar was used to access the abdomen for the camera port in the inferior aspect of the incision. A second 5-mm port was then placed in the superior aspect of the incision via a separate fascial incision for use as an operative port. This port configuration is shown in Fig. 1. Next, transabdominal suture retractors were applied by placing a straightened-out CT 1 needle on a 2-0 silk in the right subcostal margin, which was then placed through the fundus of the gallbladder to retract it cephalad. A second suture was then placed through the right upper midline near the falciform, through the infundibulum in a figure-of-eight fashion, and then out of the right lower quadrant. This suture acts as the surgeon’s left hand and can retract the gallbladder left and right during the procedure without use of a standard laparoscopic grasper. Cholecystectomy was then carried out in the typical fashion, and the gallbladder was removed through the umbilicus by enlarging one of the 5-mm fascial defects. The suture retraction is shown in Fig. 2. The fascial defect was then closed with 0 Vicryl suture. The skin of the umbilicus was then carefully closed with 4-0 Monocryl, taking care to perform a good umbilicoplasty to prevent seroma and achieve an excellent cosmetic result.
https://static-content.springer.com/image/art%3A10.1007%2Fs00464-010-0943-z/MediaObjects/464_2010_943_Fig1_HTML.jpg
Fig. 1

Multiport transfascial technique; note the limited mobility of ports offered by this technique

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Fig. 2

Cephalad retraction of the gallbladder using a transabdominal suture retractor

This early version of the technique was then replaced with a single-incision single-port access technique using a Gel-Port device. This was initiated due to the fact that there was a good deal of clashing of the ports externally using the multiport technique, as discussed further below. The single-incision transfascial technique used the same skin incision and suture retractors as previously described. However, instead of multiple ports placed through separate 5-mm fascial defects, a single hand-assist gel port device was placed through a 1.5-cm fascial defect. This defect was typically only slightly larger than the size of a Hassan trocar, usually about the size made to remove a stone-filled gallbladder with the other technique. After the hand-access device was placed, a 5-mm and a 10-mm port were placed though the gel as shown in Fig. 3. This was felt to eliminate the external port clashing that occurred with the other port while also accommodating a 10-mm device if necessary without compromising ease of use. The procedure was then carried out as previously described. Final views of the abdominal scars 2 weeks postoperatively are shown in Fig. 4.
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Fig. 3

Use of the single-port access gel port device; note that separation of trocars allows for full movement of instruments

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Fig. 4

Patient 2 weeks after single-incision laparoscopic cholecystectomy; no visible scar is noted

Results

From 12 March, 2008 to April 9, 2009, 80 single-incision laparoscopic cholecystectomies were performed. Four were performed as training dual-incision cases, with the remaining 76 as true single-incision cholecystectomies. Full demographic data including age, BMI, and sex are presented in Table 1. Perioperative data are presented in Table 2. There were nine conversions to multi-incision cases. Six were to two-port cholecystectomies; the second port was placed in a right lateral position for better cephalad retraction. The other three conversions were to traditional four-port cholecystectomies. All conversions were done because of inadequate visualization of Calot’s triangle, and all surgeons described poor visualization as reason for conversion. No conversions were performed due to complications, and no conversions resulted in complications. All authors expressed poor visualization of the critical view as reason for adding ports for the procedure. There were no open conversions. Of the patients converted to multiport laparoscopy, five were being operated on for biliary colic, three for biliary dyskinesia, and one for acute cholecystitis.
Table 1

Demographic data of single-incision laparoscopic cholecystectomy patients

Parameter

Mean

Range

Age (years)

42.3

13–83

BMI (kg/m2)

26.5

17.3–39.1

Sex

66 F

 

14 M

Table 2

Perioperative data for single-incision laparoscopic cholecystectomy with OR time and conversion rate, by surgical indication

 

Operative time (min)

Estimated blood loss (cc)

Surgical indication (%)

Conversions (number)

Total

69.5 (29–102)

9 (0–20)

 

9/80

Stones

65.2

 

60

5

Cholecystitis

71.4

 

25

1

Dyskinesia

65.4

 

13

3

Polyp

65

 

1

 
There were seven patients with complications after surgery (Table 3). Of these seven, only three were considered major, requiring additional treatment. These bile leaks occurred in 3 of 80 (3.7%) patients, with two leaks from the hepatic bed and one from a cystic duct leak. The other complications were considered minor and resolved spontaneously without long-term consequences or significant treatment. There were no reoperations or major long-term sequelae associated with any single-incision case. There were no incisional hernias reported in any case.
Table 3

Complications after single-incision laparoscopic cholecystectomy

Complication

Number (%)

Total

7 (8.7)

Cystic duct leak

1 (1.2)

Accessory duct leak

2 (2.5)

Cellulitis

2 (2.5)

Seroma

0

Urinary retention

2 (2.5)

The three biliary leaks were easily treated with percutaneous drainage and ERCP. None of the biliary leaks were felt to be a result of poor visualization. These three bile leaks occurred with three different surgeons. The other complications were minor without significant consequences

Follow-up with a mean of 4.7 months was accomplished in 79% of patients. Of those reporting for follow-up, description of use of postoperative narcotics was lacking in the medical record of 13 of 65 patients (19%). Of the remaining 52 patients, 67% described less than 1 day’s use of postoperative oral narcotics. Use of postoperative pain medication is presented in Table 4.
Table 4

Use of oral postoperative narcotics

No use of pain medication

11/47 (23%)

Minimal use (<1 day)

21/47 (45%)

Moderate use (1–3 days)

6/47 (13%)

Heavy use (>4 days)

9/47 (19%)

No description documented

13/60

All patients went home on the same operative day. Of 60 patients who returned for follow-up, 13 had no description of use of postoperative narcotic. Note that 68% of patients reported minimal to no use of postoperative pain medication

Discussion

The authors began exploring this technique based on early, unpublished reports of experience from colleagues. Industry interest as well as possible patient demand prompted a critical review of our experience with this technique. The authors were among the first few practices in the country to investigate the new technology in early March 2008, and safety and feasibility concerns abounded. Was this technology safe to use? Is the increased operative time for this technique prohibitive in a very busy community-based tertiary referral center? These were the primary questions that are explored with this review.

Three bile leaks occurred in over 80 cases. These were easily treated by percutaneous drainage and ERCP stenting. All patients did well and were discharged without long-term sequelae. Two leaks were determined on postoperative ERCP to be accessory duct leaks. The other leak was from a cystic duct stump. The authors feel that this cystic duct leak was not a consequence of poor visualization but the result of a clip applier problem. During this particular case, a clip applier was used that did not close completely. This clip was removed and two clips were then placed clearly across the cystic duct and the duct ligated. However, shortly afterwards, the clip that came across the cystic artery “scissored” the artery in half. A new clip applier was used to ligate the cystic artery. The authors feel that there may have been a “scissoring” effect of the clip applier used on the cystic duct, causing the cystic duct leak. Clear critical views were obtained during this part of the procedure, and this particular complication was not felt to be related to the single-incision technique but rather to the equipment used. However, this leak occurred and is still of concern; it cannot be conclusively stated that it was not related to the single-incision technique.

These biliary leaks are not felt to be due to poor visualization. The 3.7% rate of biliary leak is slightly higher than the reported incidence of 1–3% in the published literature [57]. These three leaks occurred with three different surgeons. All occurred in their first ten cases. The cystic duct leak may or may not have been the result of the technical clip applier problem described above. The two accessory duct or liver bed leaks may or may not have been related to the technique used.

This series reports a higher than normal leak rate of 3.7%. Due to this leak rate, it cannot be stated that a single-incision approach is as safe as traditional laparoscopy, which has reported leak rates of up to 3.0%. The authors feel that a critical view was obtained in every case performed and that the leaks would likely have occurred irrespective of the technique applied. However, the reported leak rate must be included in the critical review of this new technology. The authors feel that further analysis will reveal similar leak rates as compared with traditional laparoscopy as the series progresses in the future. The authors cannot make the conclusion that the single-incision technique used is as safe given the occurrence of the accessory duct leaks reported in this series. The authors feel that these leaks may have occurred regardless of the technique used. However the authors cannot reliably state that these complications are not directly the result of the single-incision technique either. It can be stated that this technique is feasible; more data collection is needed to conclude that outcomes are similar to those of traditional laparoscopy. There were no common bile duct injuries in this series. There were no major long-term sequelae reported in this series either.

The authors believe that single-incision laparoscopic cholecystectomy is feasible. However, it must be stated that it may not be as safe as traditional laparoscopic cholecystectomy. Visualization in this series was not as optimal as with typical laparoscopy using the suture retraction method. This also distorts traditional anatomy identification. This sometimes limited the critical view and made conversion to traditional laparoscopy necessary. However, a critical view is always the goal. If this is not realized then the addition of ports is recommended in order to achieve an adequate critical view. The suture retractors used to elevate the dome of the gallbladder can only be placed to the level of the right costal margin. The authors do not recommend placing this suture retractor between the ribs, as rib pain can ensue. This limits the cephalad retraction of the gallbladder and does not create the typical triangle with which most surgeons are familiar. This suboptimal cephalad retraction typically means that the cystic artery is anterior to the cystic duct rather than superior to it with Calot’s node in between. Care must be taken to identify this unfamiliar anatomy.

Another consideration is the suboptimal right lateral retraction performed by the infundibular suture retractors. Typical laparoscopy allows for good lateral retraction and optimization of Calot’s triangle. This also stretches the cystic duct somewhat and allows easier clipping. The suture retraction used does not provide the same tension as a laparoscopic grasper, and typically the duct does not stretch out and appears thicker than is usually seen traditionally. Therefore it is often necessary to use a large clip in a 10-mm instrument rather than the medium–large clip found in most 5-mm clip appliers. This was one of the primary reasons that adoption of the single-port technique was initiated, as it allowed easy use of a 10-mm instrument if needed without the burden of having to work with a 5-mm and a 10-mm port so close together. Other techniques that do not use the suture retraction method may help with this problem, but either larger skin flaps or larger fascial incisions need to be used with currently available technology. As technology changes and provides single-incision-specific technology, this may change.

Regarding safety, care must be taken to account for the unfamiliar anatomy found using the single-incision technique due to the suboptimal cephalad retraction. As stated above, this allows for adequate but perhaps not necessarily optimal visualization of Calot’s triangle. The authors have found that working high on the gallbladder is the safest way to dissect the duct and artery free. Also, beginning dissection cephalad to the artery and freeing the gallbladder away from the liver allow for greater mobility of the gallbladder and identification of the artery. This is in contrast to the traditional method of working on the cystic duct first, which is often difficult due to the weak tension allowed by the suture retractors and the fact that often one will find the artery anterior to the duct. Working cephalad to this, similar to a “top-down” approach on the gallbladder, seems to clear up this unusual anatomy. Of course any difficulty should prompt the surgeon to convert to a two- or four-port procedure.

The authors cannot stress enough the importance of conversion to a traditional four-port procedure if necessary. Oftentimes the limiting factor of poor visibility is due to inadequate cephalad retraction. The two-port conversions in this series were due to poor visualization, and adding a right lateral port to retract the gallbladder more cephalad resolved this issue nicely. However, it cannot be stated clearly enough that, if needed, conversion to a four-port operation should be done. This should not be considered a failure or complication.

The authors believe that single-incision laparoscopic cholecystectomy is feasible, but not necessarily as safe as traditional four-port laparoscopic cholecystectomy. Visualization is sometimes not as good. The current commercially available instrumentation is usable but not optimal for this technique. The anatomy is somewhat altered from what most surgeons are used to. The primary author also believes that this technique, at its current state of advancement as of April 2009, should be performed by surgeons with significant experience in advanced laparoscopy. The current state of technology available at the time of writing makes this technique difficult and possibly dangerous if meticulous attention to detail and early conversion for difficult situations is not maintained.

Another issue that the authors wanted to answer is the impact on overall productivity. The mean operative time for single-incision laparoscopic cholecystectomy in this series was 69 min. The learning curve does seem to improve this time somewhat, but placing suture retractors will still take longer than placing a simple 5-mm port. However, this did not seem to alter overall productivity within the authors’ practice. However, it must be remembered that the procedure does take longer and that there is no special reimbursement code for this as of today. Perhaps in the future this will change.

Single-incision laparoscopic cholecystectomy is relatively easy to perform as long as one has the patience to work within its limitations. The use of a single-port access device helps address these limitations. The hand-assist device used by the authors in this series made dissection much easier, the primary reason being that this device elevates the ports from the skin in a convex fashion. This means that the ports themselves are above and not through the single 1.5-mm fascial defect. This allows for more room to work through the defect. It also spreads the ports further apart and eliminates the clashing of ports on the outside found early in the series using a multifascial technique. The gel port used in this technique also makes it easy to remove and replace ports in a slightly different location if needed. The disadvantage of this single-port access device is that it was not designed for single-incision surgery but to place a hand through and comes prefabricated with a slit for this purpose. Loss of pneumoperitoneum through this slit can be an issue but is largely minimized by placing a strip of occlusive dressing over the slit. The increased cost of this device as compared with traditional trocars may also be a limiting factor. Single-incision surgery specific ports are currently undergoing trial but are not currently available at the time of this writing.

This series demonstrated that nearly 70% of patients took either no or only a minimal amount of postoperative oral narcotics. It was common to hear that most patients were back to normal activity within 1 day. This series does not compare postoperative pain of single-incision surgery and traditional laparoscopy. This comparison is difficult and not attempted in this series primarily due to the heavy bias due to patient selection. Patients chosen for single-incision surgery were typically thin, healthy, and with outpatient gallbladder problems. This was especially true early in the series. Even in a matched cohort study it would be difficult to compare this aspect in a truly statistically significant way using retrospective evaluation of the data. This is a major disadvantage of this series and is being addressed in an ongoing prospective evaluation.

Conclusions

Single-incision laparoscopic cholecystectomy is feasible. The technique and technology for this are still in their infancy but rapidly catching up. Operative outcomes are acceptable. The leak rate in this series is a major drawback but felt to be only slightly higher than in previously published reports. Although the authors feel that the slightly higher leak rates with this technique were not directly attributable to the technique itself, this series cannot be used to state that the single-incision technique is as safe as traditional laparoscopy. More critical review needs to be done comparing morbidity with that of traditional laparoscopy. Cosmetic outcomes are certainly excellent and may drive the overall use of this technology in the future. There may be decreased pain with single-incision surgery as compared with traditional laparoscopic surgery; however, studies comparing these two techniques need to be pursued.

Disclosures

Chris Edwards and Alan Bradshaw are on the Speakers Bureau for Covidien, Inc. and Applied Medical; no direct conflicts of interest apply. Authors Paul Ahearne, Pierre Dematos, Randy Johnson, Peeter Soosaar, Dave Mauterer, and Ted Humble have no conflicts of interest or financial ties to disclose.

Copyright information

© Springer Science+Business Media, LLC 2010