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SILS anterior resection: a comparison to standard three port laparoscopic resection

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11/12/2011

Single-incision compared to standard laparoscopic high anterior resection

 

Abstract

Introduction:  Single-incision laparoscopic surgery is gaining momentum in general surgery. The aim of our study was to compare outcomes for single-incision laparoscopic high anterior resection (SILCS) with standard laparoscopic high anterior resection (StdLCS).

Methods:  Patients undergoing laparoscopic colectomy were prospectively entered into an institutional approved database.  SILCS cases were compared against patients undergoing StdLCS.  A period analysis was also performed.

Results:  Between April 2000 and April 2009, 327 (143 cancer) consecutive unselected patients underwent StdLCS with three (1%) conversions and 12 (3.6%) covering ileostomies.  After April 2009, 55 (29 cancer) consecutive, unselected patients underwent SILCS with two conversions to a three-port technique (3.6%), no conversions to open resection and two (3.6%) covering ileostomies.  There were no significant differences in age, sex, BMI or ASA grade between these two groups.  Operating time for the SILCS was significantly faster (p < 0.0001, 113 minutes SD 44 vs. 79 minutes SD 37).  The SILCS patients then tolerated a normal diet earlier (18 hours, range 2-96 vs. 10 hours range 2-24) and were discharged faster (day 3, range 1-24 vs. day 1, range 1-8).  There were no significant differences in the return to theatre, re-admissions or 30-day mortality rates.  These findings were replicated in the period analysis.  

Conclusion: SILCS for high anterior resection is feasible, safe and is quicker to perform than standard three-port laparoscopic colectomy.  SILCS seems to be associated with a faster recovery and earlier discharge.  The marginal cost increase of the single port is justified by the improved clinical outcome.

What’s new in this paper: While feasibility of colonic resection by SILS is now established, this is the only case control study that has compared its use in unselected high anterior resection to standard three-port laparoscopy.


Introduction

Single incision surgery is the latest innovation in minimal invasive surgery.  Potential advantages over standard laparoscopic surgery in theory include decreased peri-operative pain, faster patient recovery and superior cosmesis(1).  The challenge of single incision surgery stems from the confined coaxial arrangement of the instrumentation that leads to instrument conflict, poor ergonomics and may require an additional learning curve with operative skill and manual dexterity(2).  Single incision laparoscopic colorectal surgery (SILCS), like its predecessor standard laparoscopic colorectal (StdLCS), has been slow to increase its popularity.  This may reflect the difficulty of the surgery given that StdLCS is technically complex and difficult to learn.  The use of a single incision technique in other operations such as appendicectomy, cholecystectomy, nephrectomy and adrenalectomy is already well established in comparison(3). 

Although there is increasing evidence that the technique of SILCS works, studies of small numbers, mainly right sided colectomy have failed to demonstrate any of the perceived potential advantages other than perhaps cosmesis; the technique has been found to take longer and can result in high conversion rates (12-17%) with more complications(4),(5),(6),(7).  A review(8) found SILCS to be feasible and to represent cosmetic progress but with an increased cost due to equipment.   Current evidence in SILCS reports outcomes for selected patients by experienced surgeons in right-sided colectomies(9-11) but the evidence for left-sided surgery remains largely unreported(12).   

The aim of this study was to compare outcomes for SILCS in high anterior resection with a StdLCS procedure.  It is unknown if the technique is safe and feasible in all comers and patient benefit is yet to be determined.

 

 

 


Methods

A prospective electronic database has been maintained for all laparoscopic colonic resections performed by the senior author from April 2001 to June 2011.  Consecutive patients requiring colorectal surgery were considered for laparoscopic resection; there were no specific exclusion criteria.  Between April 2000 and April 2009 patients underwent StdLCS.  After April 2009 all patients received SILCS.  Patient demographics, type of resection, location of cancer, stage of the disease, operation time, conversion, and immediate and short-term outcomes were recorded. A conversion was considered to have happened if an unplanned incision (position or length) had to be made to complete the operation.  Visual analogue scales (VAS) were used to measure pain at 6 hours post-surgery.  Time to establishment of a normal diet was recorded by the specialist, enhanced recovery nursing team.  

Due to the time course of the study, a period analysis was also performed.  The StdLCS patients were divided into three groups.  The first one hundred were in the “Early Learning Curve” (ELC) group.  The next group marked the “Start of Enhanced Recovery” (ER) when the use of routine Patient Controlled Analgesia (PCA) was stopped and intra-operative Trans-Abdominal Peritoneal (TAP) blocks introduced.  Patients then received immediate solid diet as tolerated and were discharged once stable post-operatively.  The final group “Enhanced Recovery Protocol” (ERP) consisted of the patients operated on after the introduction of the current enhanced recovery protocol.  This protocol includes discharge criteria and was unchanged over the time period of ERP and SILCS.  This is supervised by the enhanced recovery nurses who feed and mobilise the patients according to the protocol (available on request) and ring the patients daily at home after discharge.       

Patients received a phosphate enema on the morning of surgery.  The components of our StdLCS technique comprised: three-ports, an extended umbilicus incision for specimen extraction, TAP blocks and the avoidance of epidurals (13), (14).  SILCS was performed using standard instrumentation and a single access port sited at the umbilicus (1), (15).  Catheters were removed in theatre and patients were actively mobilised and allowed diet as tolerated according to the enhanced recovery protocol. 

SPSSX® was used to test normality of data and to perform analysis. Differences between means of normally distributed variables were assessed by the t- test; the Mann-Whitney test was used for non-parametric data.  Chi-square was used to test proportions.  P-values < 0.05 were considered statistically significant.  The patients’ data were held on a password protected, institutionally approved Microsoft Excel database (Microsoft ® Corporation, Redmond, Washington, USA).

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Results

327 (143 cancer) consecutive unselected patients underwent StdLCS for high anterior resection with three (1%) conversions and 12 (3.6%) covering ileostomies.  55 (29 cancer) consecutive, unselected patients underwent SILCS for the same operation with two conversions to a three-port technique (3.6%), no conversions to open resection and two (3.6%) covering ileostomies.   There were no significant differences in age, sex, BMI or ASA grade between these two groups.   Operating time for the SILCS was significantly faster (p < 0.0001, 113 minutes SD 44 vs. 79 minutes SD 37).  The SILCS patients then tolerated a normal diet earlier (18 hours, range 2-96 versus 10 hours range 2-24) and were discharged faster (day 3, range 1-24 versus day 1, range 1-8).  There were no significant differences in the VAS for pain or in the return to theatre, re-admissions or 30-day mortality rates.

After the period analysis, identical results were found.  Table 1 displays the patient demographics.  Table 2 shows the outcomes of surgery.  The operative time reduced after the ELC and then decreased again with the introduction of SILCS.  After the introduction of enhanced recovery the time to solid diet and discharge decreased.  A further significant improvement with reduction in time to solid diet and earlier discharge was seen again with SILCS.The cancer immediate outcomes can be seen in Table 3 with no difference in T stage on histology; all resections were R0.  The number of lymph nodes was greater in the SILCS group. 

The complications can be seen in Table 4.  The SILCS were more likely to go into urinary retention.  There were five SILCS patients readmitted after discharge; two were simply assessed and discharged home, one had an ileus and two returned to theatre (anastomotic leak and small bowel obstruction from a haematoma).  The latter patient also went into atrial fibrillation and had a pulmonary embolus.  Both were eventually discharged well.

 

 

 

 


Discussion

Single incision surgery was developed to reduce the invasiveness of traditional well-established multiport laparoscopy and despite much enthusiasm, its role in colorectal surgery has yet to be defined. The reasons for the slow uptake by those resistant to its generalised roll-out may be concerns over the effectiveness, appropriateness, usefulness and expense of the technique for minimal gain, as well as the technically demanding learning curve(4).  These results report a single surgeon’s experience in using SILCS high anterior resection with an “all comers” approach.  This demonstrates SILCS high anterior resection can be performed safely with advantages over the previously established three-port technique.  Of note, the SILCS patients both established a normal diet and were discharged earlier.   

An increasing number of small case-matched studies have shown that SILCS is feasible and safe for segmental right-sided resection(6),(7) and appears to have results, including operative time and time to discharge which are similar to standard multiport colectomy.  Adequate lymph-node harvest and margin clearance has also been reported(5),(6),(7),(16),(17),(18). 

Length of stay is increasingly being used by health care providers,although not necessarily by patients and surgeons, as a marker of surgical quality and overall care.  One paper also reported benefits with a significant reduction in both length of stay and pain scores on days one and two for right hemi-colectomy SILCS(19), although their study did contain a number of hand-assisted cases.  However another study published conversion rates and major morbidity (death from pulmonary embolus and a delayed thermal injury) at 12% for SILS(7).  Small numbers  (14 patients) of case-control studies of segmental colectomy have reported similar themes(20), whilst others report that SILS has a longer operation time (30 minutes on average), requires more conversions (17%) and does not result in an earlier discharge(4).  These differences to our results may reflect the small numbers previously studied.  

Possible confounding factors include the time period of the study and the place of surgery.  While it is not possible to control for these influences the period analysis produced the same results.  This included the differences seen since between the ERP and SILCS groups when the enhanced recovery protocol was nurse lead and unchanged over that time period in both sites of surgery.

A recent paper by Ross et al(5), representative of the slowly developing surgical literature analysing the development of SILS, commented that outcome data is virtually absent, especially when used for the left-side of the colon.  In their multi-surgeon study of 39 SILS cases (30 right-sided, eight sigmoid colectomies, and one low anterior resection) they conclude that in selected patients, experienced surgeons can perform SILS colectomy safely but that the benefits are not immediately apparent.  McNally(21) on the other hand demonstrated that SILS can be performed in an equivalent operating time for standard laparoscopic colectomy but with a shorter length of stay.  

In an attempt at defining the optimum treatment modality a small (60 patients) randomised controlled trial (NCT01101672) has begun recruiting in Hong Kong with primary end points being post-operative pain on coughing and analgesia consumption.  The “SILVERMAN1” trail (NCT01319890) of SILS for right hemi-colectomies versus existing minimal access resection for cancer aims to recruit a more realistic 300 patients but is not yet open for recruitment.  Using the standard deviations we found for time to discharge the power study for a significance level (alpha) of 0.05 (two-tailed) would need 90 patients in each arm of a randomised study.  This would give a power of 95% to find the same 2-day improvement in discharge time.  For a 1-day improvement there would need to be 300 patients.  This paper confirms the need for large randomised studies to demonstrate the real benefits of SILCS compared with standard laparoscopic resections.

In conclusion, we have demonstrated that SILS can be used routinely for high anterior resection and its performance does not mitigate against training and service provision.  The surgery can be performed safely with apparent advantages over our established three-port technique.  The SILCS patients ate a normal diet sooner and were being discharged earlier with resultant benefit for the local health-care system.  These advantages, if confirmed by others would easily offset the increased cost of the equipment.  We have also reported similar advantages for more complex SILS resections(1) including revisional surgery and unselected cases of restorative procto-colectomy and ileoanal pouch(22).  The learning curve of SILS has been debated(23) but if there is a learning curve, the results should in future be even more significant. 

 


 

Reference List

 

(1) Chambers WM, Bicsak M, Lamparelli M, Dixon AR. Single-incision laparoscopic surgery (SILS) in complex colorectal surgery: a technique offering potential and not just cosmesis. Colorectal Dis 2011 Apr;13(4):393-8.

(2) Romanelli JR, Earle DB. Single-port laparoscopic surgery: an overview. Surg Endosc 2009 Jan 1;23:1419-27.

(3) Ahmed K, Wang TT, Patel VM, Hagpal K, Clark J, Ali M, et al. The role of single-incision laparoscopic surgery in abdominal and pelvic surgery: a systematic review. Surg Endosc 2011 Jan 1;25:378-96.

(4) Champagne BJ, Lee EC, Leblanc F, Stein SL, Delaney CP. Single-incision vs straight laparoscopic segmental colectomy: a case-controlled study. Dis Colon Rectum 2011 Feb;54(2):183-6.

(5) Ross H, Steele S, Whiteford M, Lee S, Albert M, Mutch M, et al. Early multi-institution experience with single-incision laparoscopic colectomy. Dis Colon Rectum 2011 Feb;54(2):187-92.

(6) Waters JA, Guzman MJ, Fajardo AD, Seizer DJ, Wiebke EA, Robb BW, et al. Single-port laparoscopic right hemicolectomy:  a safe alternative to conventional laparoscopy. Dis Colon Rectum 2010 Jan 1;53(11):1467-72.

(7) Adair J, Gromski MA, Lim RB, Nagle D. Single-incision laparoscopic right colectomy: experience with 17 consecutive cases and comparison with multiport laparoscopic right colectomy. Dis Colon Rectum 2010 Jan 1;53(11):1549-54.

(8) Leblanc F, Champagne BJ, Augestad KM, Stein SL, Marderstein E, Reynolds HL, et al. Single incision laparoscopic colectomy: technical aspects, feasibility, and expected benefits. Diagn Ther Endosc 2010;2010:913216.

(9) Chen WT, Chang SC, Chiang HC, Lo WY, Jeng LB, Wu C, et al. Single-incision laparoscopic versus conventional laparoscopic right hemicolectomy: a comparison of short-term surgical results. Surg Endosc 2011 Jun;25(6):1887-92.

(10) Curcillo PG. Single-incision laparoscopic right hemicolectomy. Br J Surg 2010 Dec;97(12):1884.

(11) Keshava A, Young CJ, Mackenzie S. Single-incision laparoscopic right hemicolectomy. Br J Surg 2010 Dec;97(12):1881-3.

(12) Ross H, Steele S, Whiteford M, Lee S, Albert M, Mutch M, et al. Early multi-institution experience with single-incision laparoscopic colectomy. Dis Colon Rectum 2011 Feb;54(2):187-92.

(13) Dalton SJ, Ghosh A, Greenslade GL, Dixon AR. Laparoscopic colorectal surgery - why would you not want to have it and, more importantly, not be trained in it? A consecutive series of 500 elective resections with anastomoses. Colorectal Dis 2011 Feb;13(2):144-9.

(14) Zafar N, Davies R, Greenslade GL, Dixon AR. The evolution of analgesia in an 'accelerated' recovery programme for resectional laparoscopic colorectal surgery with anastomosis. Colorectal Dis 2010 Feb;12(2):119-24.

(15) Gash KJ, Goede AC, Chambers W, Greenslade GL, Dixon AR. Laparoendoscopic single-site surgery is feasible in complex colorectal resections and could enable day case colectomy. Surg Endosc 2011 Mar;25(3):835-40.

(16) Law WL, Fan JK, Poon JT. Single-incision laparoscopic colectomy: early experience. Dis Colon Rectum 2010 Mar;53(3):284-8.

(17) Katsuno G, Fukunaga M, Nagakari K, Yoshikawa S, Ouchi M, Hirasaki Y. Single-incision laparoscopic colectomy for colon cancer: early experience with 31 cases. Dis Colon Rectum 2011 Jun;54(6):705-10.

(18) Boni L, Dionigi G, Cassinotti E, Di GM, Diurni M, Rausei S, et al. Single incision laparoscopic right colectomy. Surg Endosc 2010 Dec;24(12):3233-6.

(19) Papaconstantinou HT, Sharp N, Thomas JS. Single-Incision Laparoscopic Right Colectomy: A Case-Matched Comparison with Standard Laparoscopic and Hand-Assisted Laparoscopic Techniques. J Am Coll Surg 2011 Mar 18.

(20) Wolthuis AM, Pennickx F, Fleuws S, D'Hoore A. Outcomes for case-matched single port colectomy are comparable with conventional laparoscopic surgery. Colorectal Dis 2011 Jan 1;in press.

(21) McNally ME, Todd MB, Brown KM. Single-incision laparoscopic colectomy for malignant disease. Surg Endosc 2011 Jun 3.

(22) Gash KJ, Goede AC, Kaldowski B, Vestweber B, Dixon AR. Single incision laparoscopic (SILS) restorative proctocolectomy with ileal pouch-anal anastomosis. Surg Endosc 2011 Jul 15.

(23) Hassan I, Advani V. Single incision laparoscopic colon surgery. Is the ride worth the curve? Colorectal Dis 2010 Sep;12(9):847-8.

 

 


 

Table 1

 

Patient Demographics

 

 

 

 

 

 

Std LCS

SILCS

Significance

 

Early Learning Curve

Start of Enhanced Recovery

Enhanced Recovery Protocol

 

 

Number

100

197

30

55

 

Age

69, SD 13

66, SD 16

65, SD 13

63, SD 13

NS

Sex

31 male

79 male

12 male

27 male

NS

BMI

28, (19– 36)

26, (18 – 40)

26, (19 – 42)

26, (17-41)

NS

ASA I & II

86*

121

17

38

Lower ASA

in ELC

ASA III & IV

14*

76

13

17

Cancer

38

90

15

29

NS

 

* = significant when compared to SILCS

 

 

 

 

 

 

 

 

 


 

Table 2

 

Period analysis of outcomes of surgery

 

 

 

Std LCS

SILCS

 

 

Early Learning curve

Start of Enhanced Recovery

Enhanced Recovery Protocol

 

 

Significance

Operative time, (mins)

135, SD 53

95, SD 42 ?

 

113, SD 44

79, SD 37 *

? p=0.01

* p<0.01

Conversions

1

2

0

2

NS

Ileostomies

6

3

3

2

NS

Time to solid diet

48, (4-120)

18, (2-96) ?

18, (5-48)

10, (2-24) *

? p<0.01

* p<0.01

Time to discharge

5, (2-32)

 

3, (1-24) ?

 

3, (1-22)

 

1, (1-8) *

 

? p<0.01

* p<0.01

Readmissions

1

11

3

5

NS

Return to OT

1

12

13

2

NS

30 day mortality

1

2

0

0

NS

 

? = significant when compared to Early Learning Curve

* = significant when compared to Start of Enhanced Recovery and Enhanced Recovery Protocol

 

 

 

 

 

 

 

 


 

Table 3

 

Cancer Outcomes

 

 

 

 

 

StdLCS

 

SILCS

Significance

R0

326

55

NS

T1

12

1

NS

T2

28

7

T3

83

13

T4

18

7

Lymph nodes

14 (5-53)

18 (2-34)

P < 0.01

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

Table 4

 

Complications of Surgery

 

 

 

StdLCS

 

SILCS

Significance

Numbers

327

55

 

Short Term

 

 

 

Anastomotic bleed

0

2

p=0.02

Anastomotic leak

11

1

NS

Bleeding

2

1

NS

Pulmonary embolus

4

2

NS

Small bowel obstruction

0

1

NS

Urinary retention

3

4

p=0.01

Long Term

 

 

 

Incisional hernia

6

1

NS

Anastomotic stricture

1

0

NS

 

 

 

 

 

 

 

 

 


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