Preference
J. Göhl, S. Merkel, W. Hohenberger J. Göhl ( u)
Department of Surgery, University of Erlangen, Erlangen, Germany e-mail: jonas.goehl@chir.imed.uni-erlangen.de
Abstract
Since laparoscopic surgery in rectal cancer was introduced ten years ago large patient collectives have been published by several authors in the meantime. The literature was carefully reviewed to analyse data on postoperative complications, long term prognosis and quality of life after laparoscopic surgery for rectal cancer to answer the question whether laparoscopic surgery is still just feasible or maybe has even reached the golden standard.
The review showed that there is not a single prospectively randomized trial published comparing laparoscopic vs. open surgery for rectal cancer. It is clearly evident that until now the most laparoscopic series are published with patients selected according to criteria that vary significantly especially regarding the kind of procedures performed (anterior, low anterior, intersphincteric resections and abdomino-perineal excision), other demographic items like gender, body mass index, eventual prior laparotomies, emergencies and tumor related characteristics like tumor stage or T-categories.
At the moment any data concerning outcome from prospectively randomized trials comparing laparoscopic versus open surgery for rectal cancer are miss- ing. Therefore, there is more speculation and belief concerning the true quality of laparoscopic surgery. The review in the literature only indicates, that laparo- scopic surgery for rectal cancer is feasible. To prove the potential advantage of laparoscopic surgery in rectal cancer randomized trials are essential. If a surgeon discusses laparoscopic surgery outside a randomized trial, he should go through a questionnaire, presented in the paper which reflects the present situation without any proven advantage and not available long term results and should leave a final decision to the patient.
Recent Results in Cancer Research, Vol. 165
Springer-Verlag Berlin Heidelberg 2005 c
Introduction
The first laparoscopic operations for colorectal cancer were performed more than 10 years ago. Thus one could assume that there are enough data available in the literature to evaluate the outcome, quality of life and cost-effectiveness of this procedure and to judge whether a laparoscopic surgery is still simply feasible or whether it has become the golden standard. Focusing on rectal cancer including total mesorectal excision (TME), the literature was carefully reviewed to collect data on postoperative complications, long-term prognosis and quality of life figures after laparoscopic surgery for rectal cancer.
Facts
The first result of this review was that there is no single prospectively randomized trial published comparing laparoscopic versus open surgery for rectal cancer. It was clearly evident that till now only series are published with patients selected according to criteria that are never fully transparent and may vary significantly.
This is true for the following:
1. The kind of procedures performed (anterior, low anterior, intersphincteric resections and abdominoperineal excision)
2. Other demographic items such as gender, body mass index, eventual prior laparotomies, emergencies
3. Tumor-related items such as UICC stage, T categories and others
In this context it should be noted that an equal distribution of stages in corre- lation to a conventional series does not exclude patient selection.
Any stage-III patient may have a very small pT1 carcinoma with a single lymph node metastasis which may cause no technical problem or adverse effect during preparation. However, a T4 lesion without any lymph node metastases is still stage II, which may even be impossible to be touched by laparoscopic instruments without laceration: the T category may be much more important when judging the extent of selection in a given report. For that reason, one needs reference figures from unselected series with open surgery including the procedures performed and all the demographic data needed.
Procedures Performed and Distribution of the pN Category at the Erlangen Registry of Colorectal Carcinoma
In our own department, over the last years, the rate of perineal excisions was 20.9%
(n=80). In another one, the rate (n=307) of anterior or low anterior resection
was 74.5%, including 49 cases with abdominoperineal intersphincteric resection
and perineal anastomosis. In addition, a small number of local excisions were
performed by a perineal approach (Table 1).
Table 1. Operative procedures in conventional rectal cancer surgery, Surgical Department, University of Erlangen 1995–2000 (UICC I—III, n=412)
Operative procedure n %
Anterior resection 307 74.5
(including intersphincteric resection) 49 11.9
Perineal excision 80 19.4
Local excision perineal 25 6.1
Table 2. Distribution of pT, pN and stage, Surgical Department, University of Erlangen 1995–2000 (UICC I—III, R0 resections, n=373, mean number of regional lymph nodes examined: 26)
n %
pT1 46 12.3
pT2 124 33.7
pT3 188 50.7
pT4 14 3.8
pN0 227 60.9
pN1 95 25.5
pN2 51 13.6
Stage I 132 35.4
Stage II 95 25.5
Stage III 146 39.2
In the same period, the majority of curatively resected patients (R0) without distant metastases presented with stage III (39.2%; n=146) disease. The rate of stage I disease was 35.4% (n=132).
pT4 tumors were found in 3.8% of the cases (n=14). The majority of the cases were pT3 tumors (n=188). In total, 60.9% had no lymph node involvement (n=227).
The mean number of lymph nodes examined was 26 (Table 2). Of all patients, 3.6%
presented as an emergency.
Locoregional Recurrence
The most important impact of rectal cancer surgery is the prevention of locore- gional recurrence because it reduces survival significantly.
Potentially curative approaches include extended, mainly multidisciplinary therapeutic modalities that may affect the patient significantly. If, however, failure of locoregional control is inevitable, this will lead to intractable problems for the patient.
In the literature, including our own results, local recurrence rates are seen in
between 2.6% and 17.1% of the cases, depending on the length of follow-up and
eventual subgroup analysis including high-risk patients.
Table 3. Local recurrence rates (LR rate) after conventional surgery with TME
LR rate Median follow-up (months) Simunovic et al. [13] (2003) n=115: no RCT 2.6% 29
n=35: with RCT 17.1%
Kneist et al. [5] (2003) n=87 4.9% 24
Bülow et al. [2] (2003) n=311 11% 36
Erlangen 1995–2000 n=373 8,8% 52
Table 4. Local recurrence rates (LR rate) after laparoscopic TME (treatment series by individual surgeons or centers)
n LR rate Median follow-up
(months)
Fleshman [3] (1999) 31 19.0 19
Bärlehner [1] (2001) 138 3.8 40
Hartley [4] (2001) 21 5.0 38
Lezoche [6] (2002) 29 24.1 49
T2,T3
Quah [9] (2002) 40 – –
Reis Neto [10] (2002) 32 3.1 –
Scheidbach [12] (2002) 380 6.6 25
Yamamoto [14] (2002) 70 3.0 23
Tis, T1, T2
Morino [7] (2003) 87 4.2 46
Evaluable malignancies
Patankar [8] (2003) 66 3.5 52
Rullier [11] (2003) 32 – –
In our own department, without any patient selection, the locoregional recur- rence rate is 8.8% after a follow-up period of 52 months (Table 3).
In the literature for laparoscopic total mesorectal excision for rectal cancer over the last 4 years, recurrence rates at various follow-up intervals ranged from 0% to 24.1%, or were not mentioned. The majority of reports do not specify T categories.
In some series, even benign lesions are included. In not a single publication all the demographic data needed for adequate analysis were given (Table 4).
The largest series was published by Scheidbach et al. [12], including 380 patients.
This paper presents the data of 23 institutions as a kind of patient care study. Stage distribution does not indicate a selection bias. However, as mentioned above, the T categories would be much more important to allow deeper analysis. In this series, the abdominal perineal excision rate was 39.2%, which nevertheless indicates a relevant selection (Table 5).
Clinical reality is probably best reflected by a study published by Hartley et
al. [4], in which 42 patients entered an intention-to-treat study. Of these patients,
Table 5. Multicenter study, 23 institutions, 380 patients, 5-year period laparoscopic surgery
Scheidbach et al. [12]
Ant. resection n=231 60.8%
Abd. perineal excision n=149 39.2%
Operating time (mean) 218 min
Converting rate 6.1%
Morbidity rate postoperative 37.6%
Number of lymph nodes examined (mean) 13.0
Local recurrence rate 6.6%
Overall survival 86.6%
Stage distribution
UICC I n=129 34.0%
UICC II n=112 29.5%
UICC III n=139 36.5%
14 needed early conversion; 6 of the 28 remaining patients finally needed partial open dissection. Thus, only 21 curative total mesorectal excisions were completed laparoscopically (Fig. 1). Comparing early postoperative outcome figures within the three groups, it could be demonstrated that bowel movement started 1 day earlier in the laparoscopic group and hospital stay was 1.5 days shorter compared to the open group (10%). Operation time was 55 min longer (44%). The need of analgesic drugs was the same. However, in the conversion group, all parameters were worse, due to postoperative paralysis, which was the same compared to the open group. Astonishingly enough, the clinical leakage rate in the laparoscopic group was fourfold higher, for various reasons (Table 6).
Comparison- Study
(Hartley et al. [4])Flow diagram laparoscopic surgery 42 total
14 early conversions 28 laparoscopic dissections
21 ant. res.
6 parial open dissection 15 total laparoscopic res.
21 total 21 total
21 total laparoscopic laparoscopic laparoscopic TME TME TME
control group n = 22 (open procedure) 1
non curative
6 total
laparoscopic excision 7 abd. perin. excis.
Figure 1. Laparoscopic surgery with TME
Table 6. Laparoscopic surgery with TME: comparison study, Hartley et al. [4], clinical data
Group Operating Postoperative Analgesia Hospital stay
time (min) paralyses required (days) (days) (days)
Laparoscopic 180 3 4 13.5
(n=21) (168–218) (3–4) 3–6 (10–27)
Converted 146 4 5 16
(n=21) (136–180) (4–7) (4–7) (12–33)
Open 125 4 4 15
(n=22) (104–144) (3–5) (3–5) 12–29)
Survival
Again, the interpretation of survival figures from laparoscopic surgery for rectal cancer needs reference figures from open series for the reasons mentioned above.
In this context, it is important to postulate that optimal figures should be used for comparisons. Otherwise some results may be misinterpreted, for example those published by Patankar et al [8]. These authors demonstrated a nonsignificant better survival for laparoscopically operated patients with an advantage for all patients after 5 years and for stage I patients after 7 years. However, if one compares these figures with the survival rates from our department, including all patients prospec- tively documented without any selection with a cancer related 5-year survival of 83.6% (n=373) and for stage I patients 94.7%, these figures are much higher than the reference figures from open surgery in this study (Table 7). Thus the comparison
Table 7. Cancer-related 5-year survival rate, Surgical Department, University of Erlangen 1995–2000 (UICC I–III, R0 resections, n=373)
n 5-Year survival rate (%)
All 373 83.6
pT1 46 100.0
pT2 124 90.2
pT3 188 78.9
pT4 14 39.1
pN0 227 93.9
pN1 95 72.3
pN2 51 59.9
Stage I 192 94.7
Stage II 95 93.0
Stage III 146 67.7
of absolute figures indicates that many results obtained in some studies comparing open versus laparoscopic approach do not represent optimally obtainable results.
Quality of Life
There is one prospectively documented trial comparing quality of life. In this study, postoperative male sexual dysfunction is found significantly more frequently in the laparoscopically operated group (Table 8).
Table 8. Quality of life: postoperative male sexual dysfunction, Quah et al. [8]
Laparoscopic Open operation p approach (n=15) (n=22)
Erectile function 0.03
∗No difference 9 19
Reduced 1 2
Impotent 5 1
Able to ejaculate 0.01
∗Yes 9 21
No 6 1
Overall sexual dysfunction
a7 1 0.004
∗Median (i.q.r.) change in sexual satisfaction -1 (-3.0) 1 (-0.25) 0.06
∗∗∗
Fisher’s exact test;
∗∗Mann-Whitney U test.
a
