Surg Endosc (2011) 25:2919–2925 DOI 10.1007/s00464-011-1643-z

Laparoscopy within a fast-track program enhances the short-term results after elective surgery for resectable colorectal cancer Francesco Feroci • Katrin C. Kro¨ning • Elisa Lenzi • Luca Moraldi • Stefano Cantafio Marco Scatizzi

•

Received: 27 September 2010 / Accepted: 17 February 2011 / Published online: 18 March 2011  Springer Science+Business Media, LLC 2011

Abstract Background Whether laparoscopic colorectal resection improved recovery within an enhanced recovery program was investigated. Methods This study was designed as a query of a prospectively maintained colorectal database to identify 350 patients who underwent elective colorectal resection with primary anastomosis for colorectal cancer between January 1, 2005 and December 31, 2009. Patients were categorized into two groups (laparoscopic and open resection), and demographic, treatment, and outcome variables were independently reviewed for accuracy. A detailed fast-track protocol was prepared and distributed to all patients, department doctors, and nurses to standardize the treatment. Results A total of 209 patients underwent laparoscopicassisted colorectal resection, and 141 had open surgery. There was no difference between the two groups in terms of age, sex, BMI, ASA, comorbidity, previous abdominal surgery, preoperative chemoradiotherapy, cancer site, and AJCC 2002 staging. Twenty-three patients in the laparoscopic group required conversion to an open procedure due to hemorrhage, tumor extension, or technical difficulties. Laparoscopic patients had earlier tolerance of diet, bowel movement, flatus and stool canalization, mobilization, suction drain removal, and interruption of analgesic drug administration. Length of postoperative stay was shorter (4 vs. 7 days, p = 0.0004) and fewer postoperative

F. Feroci (&)
K. C. Kro¨ning
E. Lenzi
L. Moraldi
S. Cantafio
M. Scatizzi Department of General Surgery, Misericordia and Dolce Hospital, Piazza dell’Ospedale 5, 59100 Prato (Po), Italy e-mail: [email protected]

nonsurgical complications (3 vs. 13% p = 0.009) were registered for the laparoscopic group. Conclusions This study suggests that within an enhanced recovery program, laparoscopic resection may provide the best short-term clinical outcomes for patients with resectable colorectal cancer. Keywords Laparoscopy
Colorectal surgery
Colorectal cancer
Fast-track surgery

Since the first multimodal perioperative clinical pathway based on the best available scientific evidence was published by Kehlet et al. in 1995 [1], ‘‘fast-track’’ rehabilitation or enhanced recovery after surgery (ERAS) has been successfully adopted by several centers in the United Kingdom, Scandinavia, and Germany [1–3]. The goal of this novel approach to patient care is to decrease the perioperative stress response to surgical trauma and thereby decrease complication rates in elective surgery [4]. The benefits of fast-track surgery, which include improved recovery, shortening of hospital stay, decreased duration of paralytic ileus, and reduction in deterioration of vital organs (cardiopulmonary, gastrointestinal, and muscular) have been established by several studies, including more than six randomized trials [5–7]. Many protocols have been put forward by hospital groups, which consist of varying individual preoperative, intraoperative, and postoperative fast-track elements, such as preoperative counselling and feeding, no bowel preparation, perioperative high oxygen concentrations, active prevention of hypothermia, and no routine use of nasogastric tubes and drains [8–14]. One of the elements adopted by almost all groups is minimally invasive surgery, especially in studies conducted during the past decade

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when laparoscopy became very popular, because it was associated with less postoperative pain and a reduced length of stay [15, 16]. The feasibility of laparoscopic colectomy, in terms of safety and oncological radicality, since 1991 [17] has been reported in the following trials: COST [18], CLASICC [19], Barcelona [20], and COLOR [21]. These randomized, controlled trials demonstrated that improvement in postoperative short-term results could be achieved without compromising long-term oncological results. Some studies evaluating minimal access surgery within an enhanced recovery program have demonstrated benefits in favor of the laparoscopic approach in the early postoperative period, but others have shown minimal differences [22, 23]. The goal of our study was to investigate whether laparoscopic colorectal resection improved recovery within a multimodal rehabilitation program.

Materials and methods After institutional review board approval, we performed a query of a prospectively maintained divisional database to identify all patients who underwent elective colorectal resection for colon cancer between January 1, 2005 and December 31, 2009 at our institution. Exclusion criteria included those with severe physical disability and in longterm care, patients who were medically unfit for surgery, any nonelective admission, preoperative evidence of distant metastases, age younger than 18 years, pregnancy, and patients undergoing total colectomy, abdominoperineal resection, or Hartmann intervention. Patients classified as ASA IV were excluded from the analysis. To have realistic results of the applicability of the fast-track protocol during routine clinical practice, patients operated on during all periods of the year were considered, and those operated on during holidays of the ‘‘Fast Track Research Team’’ were not excluded. Demographic, treatment, and outcome variables were independently reviewed for accuracy. Patients were categorized into two groups (laparoscopic and open resection) based on their preoperatively assigned surgery protocol. A decision on the suitability for laparoscopicassisted resection was made on a case-by-case basis by the operating surgeon, depending on his/her practice or patient’s preference. Surgical interventions Three colorectal fellowship-trained surgeons performed or supervised both open and laparoscopic procedures and were involved in all operations. In the open group, rightsided hemicolectomy was performed through a right horizontal incision above the umbilicus (surgeon choice), and

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all other procedures were performed through a midline vertical incision that was extended as necessary. Laparoscopic right hemicolectomy with a total intracorporeal side-to-side anastomosis was performed, with three 12-mm trocars in left hemiabdomen. The specimen was extracted protected by a plastic drape from a 3-cm Pfannenstiel incision. Laparoscopic left hemicolectomy was executed with three 12-mm trocars in the right hemiabdomen. For anterior resection of the rectum (RAR), we used a fourth 5-mm trocar. The left colonic angle was always mobilized. In low RARs, a total mesorectal excision was always performed, whereas in RARs for upper rectal cancer, we performed a partial mesorectal excision at least 5 cm below the neoplasm. The colon was extracted from a 3-cm transverse laparotomy in the right abdomen and was protected by a plastic drape. Anastomosis was always performed with a termino-terminal mechanical Knight-Griffen with a 29-mm circular stapler. A loop ileostomy was executed only at the end of low RARs, using the 3-cm extraction laparotomy in the right hemiabdomen. A 19-Fr suction drain was positioned at the surgeon’s discretion. Due to the current lack of uniform consensus regarding the definition of conversion in laparoscopic colon surgery, we defined laparoscopic-converted colon resection as the abortion of the laparoscopic approach and the performance of a conventional abdominal incision for completion of the operation. Any incision [6 cm was considered a conversion to an open procedure. Fast-track surgery protocol A detailed protocol, described previously [24], was prepared and distributed to all patients, department doctors, and nurses to standardize the treatment (Table 1). Patients and their families were informed about the operative and perioperative treatment in detail, and a signature for consent was obtained. Patients were hospitalized on the day before the intervention, with all preoperative exams (blood tests, CT, colonoscopy, etc) already executed. On the same day, a mechanical bowel preparation with a single dose of phosphate magnesium was performed only in patients who were to undergo surgery on their rectum. All patients were allowed to take clear liquids up to 4 h before surgery. Patients with respiratory illnesses or heavy smokers were provided with an incentive respiratory device to use even in the postoperative period. An antithrombotic prophylaxis was administered 12 h before the intervention and continued until 14 days after discharge. An antibiotic (ampicillin/ sulbactam 3 g IV) prophylaxis was administered 30 min before interventions and repeated after 3 h if necessary. No premedication was administered. A nasogastric tube (NGT), inserted after the orotracheal intubation, was always removed at the end of surgery. To maintain a normothermic

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Table 1 Protocol for perioperative ‘‘fast-track’’ rehabilitation in elective colonic surgery Time

Procedure

Preoperative

• Preoperative checks completed • Admission to hospital and informed consent • Mechanical bowel preparation for rectal resection only • Free diet (with limitation of fibers) • 12 h before the operation antithromboembolic prophylaxis • Use of incentive respiratory device for high-risk patients for at least 5 days before

Day of intervention

• Drink liquids up to 4 h before the operation • Antibiotic prophylaxis (Cephazolin 2 g and Metronidazole 500 mg i.v. during anaesthesia induction and a second dose repeated after 3 h if required) • No premedication • Active prevention of hypothermia with warmed fluids and Bair Hugger • Nasogastric tube removed at the end of surgery • Urinary catheter always used • Analgesic elastomeric pump at 2 ml/h, for 48 h with Tramadol 300 mg, Tromethamine Ketorolac 90–120 mg, and Ondansetron 10 mg

Postoperative day 1

• 3–6 h after the operation, the patient could drink water and was mobilized in bed or armchair (if possible go to the bathroom) • Urinary catheter removed • Use of incentive respiratory device • Armchair for at least 1–2 h two times per day • Semi-liquid diet and reduction to 1,000 ml of i.v. fluids

Postoperative day 2

• Sit twice a day in the armchair for at least 8 h and leave room at least once

From postoperative day 3

• Dischargeable, if restored bowel function, ambulation, and eating in absence of complications

• Solid diet and stop i.v. fluids

body temperature, the temperature in the operating room was increased to 22C, and a Bair hugger and warmed intravenous fluids were applied. In patients undergoing RAR, the bladder catheter was removed on the second postoperative day in the absence of any surgical complications. In all other cases, the bladder catheter was removed on the first postoperative day. In the absence of surgical complications, the suction drain was removed on the second postoperative day. All open surgery patients received a thoracic epidural catheter. Intraoperatively, all patients received 12 ml of 0.5% bupivacaine followed by 4 ml/h and an epidural dose of morphine (2 mg \ 70 years and 1 mg [ 70 years). The epidural analgesia continued during surgery and for 48 h with 0.25% bupivacaine and morphine 0.05 mg/ml, 4 ml/h. Laparoscopic surgery patients received Tramadol (300 mg), Ketorolac Tromethamine (90 mg), and Ondansetron (10 mg) using an intravenous elastomeric infusion pump with a constant flow (2 ml/h) for 48 h. In both groups, Paracetamol 2 g was given every 12 h. Subsequently, in the case of visual analogue scale measurements [50, 30 mg of Ketorolac Tromethamine were given up to 3 times within 24 h. After the procedure, patients were mobilized to an armchair in the evening. The next day patients were mobilized to the bathroom and kept seated in

an armchair at least for 2 h. Patients were allowed to drink water 3–6 h after the intervention and to take a semi-liquid diet on the first postoperative day. A solid diet was allowed on the second postoperative day. On the second postoperative day, patients were invited to walk out of the room and to sit in an armchair for at least 8 h. Discharge criteria Patients were considered dischargeable to their own home on the third postoperative day if they met the following criteria: absence of complications, taking at least three solid meals, stool canalization, autonomic mobilization, and a need for only oral painkillers. All patients were given clear instructions and the phone number of a doctor who was available 24 h a day. Patients who lived more than 100 km from the hospital were invited to remain near our department for at least 24 h. All patients visited the outpatient clinic after 8 days, and the histological response of their specimens was discussed. In the event of fever, abdominal pain, or vomiting, patients were readmitted to our department to study the possible presence of complications. All patients were introduced before the intervention in an active multidisciplinary team conference (surgeon, oncologist,

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radiologist, endoscopist, nurses, and psychologist) for gastrointestinal cancer, and all clinical management decisions were discussed regularly during weekly team meetings. Usually 15 days after surgery, the multidisciplinary team discussed the need for any adjuvant therapy, and, if needed, the patients were helped with psychological support and followed for all their other needs.

mean (range). Data were analyzed on an intention-to-treat basis. Data were tabulated on a Microsoft Excel spreadsheet (Excel for Windows; Microsoft Corporation, Redmond, WA) and then processed with SPSS 16.0 for Windows (SPSS, Chicago, IL). p \ 0.05 was considered statistically significant.

Results Statistical analyses Differences in clinically important baseline characteristics, intraoperative outcomes, and short term (30-day) postoperative outcomes were compared between the open and laparoscopic cohorts. A univariate analysis was performed using the Mann-Whitney U test for continuous variables, and v2 was used for categorical variables. For all analyses, p values \ 0.05 were considered statistically significance, and all tests were two-sided. Univariate results are reported as median (interquartile range) or frequency (percent); only for milliliters of transfused blood are the results reported as

Table 2 Baseline characteristics

During the study period, 350 patients who satisfied the inclusion criteria underwent elective colorectal surgery with primary anastomosis: 209 underwent laparoscopic-assisted colon resection, and 141 had open surgery. Patients’ baseline characteristics are exposed in Table 2. There was no difference between the two groups in terms of age, sex, BMI, ASA, comorbidity, previous abdominal surgery, preoperative chemoradiotherapy, cancer site, and AJCC 2002 staging. Twenty-three patients in the laparoscopic group required conversion to an open procedure due to hemorrhage, tumor extension, or technical difficulties.

Open surgery (n = 141) Age (year) Sex ratio (M:F)

71 (42–90) 85:56

Laparoscopic surgery (n = 209) 68 (30–85) 121:88

ASA grade 25 (18)

55 (26)

II

72 (51)

109 (52)

III

44 (31)

46 (22)

Comorbidity Pulmonary Cardiovascular Renal Diabetes Liver

0.612 0.795 0.301

I

BMI (kg/m2)

p value

28

26

0.733

105 (74) 29 (20)

152 (72) 37 (17)

0.549 0.273

88 (62)

115 (55)

0.098

5 (4)

6 (3)

0.733

26 (18)

13 (6)

0.07

5 (4)

5 (2)

0.423

Previous abdominal operation

37 (26)

29 (14)

0.328

Preoperative chemoradiotherapy

20 (14)

22 (10)

Cancer site

0.341 0.282

Colon

98 (69)

149 (71)

Rectum

43 (31)

60 (29)

AJCC 2002 staging ASA American Society of Anesthesiologists, BMI body mass index, AJCC American Joint committee against cancer Data are medians with ranges in parentheses for continuous variables. Data are numbers with percentages in parentheses for categorical variables

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0

4 (3)

1

22 (15)

61 (29)

–

2a

50 (35)

73 (35)

2b

4 (3)

7 (3)

3a 3b

6 (5) 22 (15)

12 (6) 30 (14)

3c

17 (12)

16 (8)

4

16 (12)

10 (5)

0.118

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Considering the intraoperative outcome (Table 3), the duration of surgery was significantly lower for open intervention (150 vs. 165 min; p = 0.001). Drain positioning was significantly lower in the laparoscopic group (21%) with respect to the open (61%) patients. No significant differences in intraoperative and postoperative blood transfusion or intraoperative complications were observed. Short-term outcomes are shown in Table 4. With respect to the open group, the laparoscopic patients had an earlier tolerance of liquid (day 1 vs. day 2; p = 0.0001) and solid diets (day 2 vs. day 3; p = 0.0001), bowel movement (day 1 vs. day 2; p = 0.0001), flatus (day 2 vs. day 3; p = 0.0001) and stool canalization (day 3 vs. day 4; p = 0.0001), mobilization (day 0 vs. day 1; p = 0.0001), Table 3 Perioperative results Open surgery Laparoscopic (n = 141) surgery (n = 209) Operation

0.103

Right hemicolectomy

56 (40)

54 (26)

Transverse resection

7 (5)

10 (5)

Left hemicolectomy

35 (25)

85 (41)

Anterior resection

p value

Table 4 Short-term (30 days) outcome in open and laparoscopic patients

Drain positioning

Open surgery (n = 141)

Laparoscopic surgery (n = 209)

41 (29)

45 (21)

p value (open vs. lap) 0.0001

Postoperative stay

7 (4–36)

4 (3–21)

0.0001*

ICU stay

0 (0–12)

0 (0–5)

0.0001*

Readmission

4 (3)

7 (3)

Mobilization (POD)

1 (1–6)

0 (1–3)

0.0001*

First bowel movement (POD)

2 (1–13)

1 (0–4)

0.0001*

First flatus (POD)

3 (1–15)

2 (0–4)

0.0001*

First stool (POD)

4 (1–18)

3 (1–12)

0.0001*

Liquid diet toleration

2 (1–16)

1 (0–8)

0.0001*

Solid diet toleration Drain removal (POD)

3 (1–20) 3 (2–30)

2 (1–14) 2 (1–9)

0.0001* 0.001*

Bladder catheter removal (POD)

1 (0–13)

1 (0–12)

0.462

NGT tube reinsertion

1

14 (10)

13 (6)

0.414

Bladder catheter reinsertion

5 (4)

12 (5)

0.175

Analgesic administration (oral or IV) pod

4 (1–14)

2 (0–16)

0.0001*

43 (30)

60 (28)

Ileostomy

15 (11)

21 (10)

0.213

Postoperative complications

Adjunctive operation

37 (26)

48 (23)

0.576

Cholecystectomy

8 (6)

21 (10)

Reintervention

6 (5)

8 (4)

0.878

Mortality

3 (2)

2 (1)

0.887

Liver resection

6 (5)

4 (2)

Liver biopsy

7 (5)

10 (5)

Peritoneal biopsy Splenectomy

1 (1) 9 (7)

– 2 (1)

Ileal resection

5 (4)

1 (0.5)

Hernia repair

4 (3)

4 (2)

Annessiectomy

5 (4)

2 (1)

Adrenalectomy

3 (2)

1 (0.5)

Pancreatoduodenectomy

1 (1)

Gastric GIST removal Open conversion Duration of surgery

2 (1)

–

23 (11)

28 (20)

25 (12)

Non Surgical

18 (13)

7 (3)

0.92 *0.009

Data are medians with ranges in parentheses for continuous variables. Data are numbers with percentages in parentheses for categorical variables ICU intensive care unit, POD postoperative day, NGT nasogastric tube

0.001*

Intraoperative

50.9 (0–1050) 42.1 (0–1750)

0.438

Postoperative

79.7 (0–1400) 58.3 (0–1750)

Blood transfusion (ml)*

Intraoperative complications

9 (7)

10 (5)

Spleen rupture

6 (5)

2 (1)

Other hemorrhage

2 (2)

4 (2)

No tumour finding

1 (1)

2 (1)

0.06 0.791

2 (1)

Data are medians with ranges in parentheses for continuous variables. Data are numbers with percentages in parentheses for categorical variables * p \ 0.05 = statistically significant

Major surgical

0.19

–

–

–

32 (15)

* p \ 0.05 = statistically significant

150 (60–270) 165 (40–345)

Colonic injury

46 (33)

suction drain removal (day 2 vs. day 3; p = 0.001), bladder catheter removal (day 1 vs. day 3; p = 0.0001) and interruption of analgesic drugs administration (day 2 vs. day 4; p = 0.0001). A significantly shorter length of postoperative stay (LOS) (4 vs. 7 days; p = 0.0004) and fewer postoperative nonsurgical complications (3 vs. 13%; p = 0.009) were registered for the laparoscopic group. There was no significant difference in the proportion of patients who required postoperative NGT or bladder catheter insertion or readmission between the two recovery groups. Considering the data presented in Table 5, it is evident that compliance with the fast-track protocol was very high for both groups, except for minimal invasiveness/transverse incision in open surgery patients.

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Table 5 Degree of protocol compliance in fast-track patients per evaluated modality Evaluated modality

Open surgery (n = 141)

Laparoscopic surgery (n = 209)

p value (open vs. lap)

Preoperative counselling

141 (100)

209 (100)

Preoperative feeding

141 (100)

209 (100)

No bowel preparation

98 (70)

149 (72)

No premedication

141 (100)

209 (100)

Active hypothermia prevention

141 (100)

209 (100)

Laparoscopy/transverse incision

50 (35)

186 (89)

No routine use of NG tube No use of drain

141 (100) 100 (71)

209 (100) 164 (78)

1 0.622

Enforced postoperative mobilization

128 (91)

203 (97)

0.511

Enforced postoperative liquid feeding

130 (92)

201 (96)

0.613

Enforced postoperative solid feeding

127 (90)

196 (94)

0.542

Early removal of bladder catheter

128 (91)

196 (94)

0.71

1 1 0.825 1 1 0.0001*

Data are numbers with percentages in parentheses for categorical variables * P \ 0.05 = statistically significant

Discussion Laparoscopic colorectal surgery has gained increasing acceptance during the past decade. The arguments made for adopting the technique despite higher costs, longer operating times, and a steep initial learning curve have been based on the improvements in patient recovery; the perceived advantages of less postoperative pain and a reduction in ileus and length of hospital stay are felt to outweigh any such disadvantages [18–21]. At the same time, the premise that multimodal rehabilitation can improve recovery after colorectal resection has been demonstrated in several studies from various countries [8, 10, 25]. The present study showed improved short-term outcomes with laparoscopic surgery for colorectal cancer compared with open surgery when both were performed within an enhanced recovery program. Both groups of patients had a shorter postoperative hospital stay than reported for standard care in colorectal cancer [26]; however, after laparoscopically assisted surgery, the hospital stay was significantly lower. Other short-term outcomes, such earlier mobilization, earlier diet tolerance, and reduced nonsurgical complications, were significantly in favor of laparoscopic surgery, and, as stated by another study [22], this approach was no more expensive. The fast-track program requires a dedicated and motivated team consisting of an anesthesiologist, surgeon, dietician, physiotherapist, social worker, and nursing team. To obtain these results, we periodically conducted meetings with all the staff. Initially, we discussed point-by-point each of the elements of the fast-track program. Then, every 2 weeks for the first 6 months and each month in the

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subsequent period, we dedicated time to review our results. By doing so, we were able to obtain the consent of all the professionals. This was, in our opinion, the key to ensuring high compliance with all points of our planned program [24]. To date, with various results, only two randomized and one retrospective trial comparing laparoscopic and open surgery for colon cancer within an enhanced recovery program have been published. Basse et al. [23] observed no differences in terms of the return of gastrointestinal function and duration of hospital stay in fast-track patients randomized to open or laparoscopic colorectal resection, whereas King et al. [22], in a subsequent study, showed that the length of stay was 32% shorter after laparoscopic surgery and that, within an enhanced recovery program, patients undergoing laparoscopic surgery recovered more quickly than after open resection. Both approaches, however, were associated with slow recovery despite a relatively short hospital stay. MacKay et al. [27] found similar results to Basse et al. [23], and they concluded that with the introduction of multimodal rehabilitation programs, the benefits of laparoscopic-assisted colon resection have not yet been shown. Several facts of our study merit discussion. First of all, patients were assigned to open surgery or laparoscopy in an uncontrolled, nonrandomized manner, and this is a limitation; nevertheless, to reduce the margin of error, data were obtained independently by two authors. As a tertiary referral center, referral bias may limit the generalizability to smaller centers or those without a similar level of complexity and volume of laparoscopic colorectal surgery. As stated before, all members of our staff (23 surgeons) were well trained for the fast-track program, however, in the

Surg Endosc (2011) 25:2919–2925

ward, a member of the ‘‘Fast-Track research team’’ (the six authors of the present study) was not always present, and this fact gave us a realistic picture of the applicability of the fast-track protocol during routine clinical practice. Despite these possible biases, this study demonstrates clinically important results and is one of the largest to date that quantifies the impact of recovery protocols after laparoscopic colectomy on the length of stay and morbidity. In conclusion, this study suggests that within an enhanced recovery program, laparoscopic resection may provide the best short-term clinical outcomes for patients with resectable colorectal cancer. Disclosures Drs. Marco Scatizzi, Katrin C. Kro¨ning, Elisa Lenzi, Stefano Cantafio, Luca Moraldi, and Francesco Feroci have no conflicts of interest or financial ties to disclose.

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