Versus Transverse Coloplasty Pouch in Heidelberg
Alexis Ulrich, Kaspar Z’graggen, Jürgen Weitz, Markus W. Büchler
A. Ulrich ( u)
Department of General, Visceral and Trauma Surgery,
Ruprecht-Karls-University Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany
e-mail: alexis.ulrich@med.uni-heidelberg.de
Abstract
Within the last 20 years various achievements have been made in the treatment of rectal cancer, improving survival and quality of life of rectal cancer patients. Espe- cially the introduction of the total mesorectal excision (TME) and the use of modern staplers, making anastomoses possible in the deep pelvis, have increased our abil- ity to cure more and more low rectal cancers by sphincter-preserving low anterior resections. Consequently, the interest in functional results after rectal reservoir reconstruction has increased significantly. Various randomized controlled trials have shown that the colon J-pouch (CJP) as a rectal reservoir reconstruction leads to better early functional results compared to the straight coloanal anastomosis (CAA). However, 30% of the patients with CJP faced late evacuation problems, requiring the chronic use of enemas or laxatives. This rate could be decreased to 10% by shortening the limb of the CJP from 8–10 cm to 5–6 cm. The transverse coloplasty pouch (TCP) was developed to provide early functional results com- parable to the CJP, while avoiding these late evacuation problems. We report the early postoperative and functional results of 106 patients undergoing low ante- rior resections with TCP due to rectal cancer between October 2001 and the end of September 2003. Furthermore, we report on a single-center randomized controlled trial to compare the new TCP technique with the gold standard technique of CJP, which we started in October 2002. The objectives were to compare the two pouch reconstruction techniques in terms of morbidity, mortality and functional results.
Introduction
The significance of improving treatment modalities for patients with rectal cancer is highlighted by the high incidence of the disease (10–20/100,000 inhabitants), making it the fourth leading cancer in men and third leading cancer in women in Western countries. Approximately 300,000 new cases and 200,000 deaths occur in Europe and the USA combined, each year [1].
Recent Results in Cancer Research, Vol. 165
Springer-Verlag Berlin Heidelberg 2005c
of rectal cancer, improving survival and quality of life of rectal cancer patients.
The introduction of total mesorectal excision (TME) by Heald and its acceptance as the gold standard in rectal cancer surgery has to be recognized as the most significant contribution. Just by adopting the rules of TME, local recurrence rates can be reduced from 20%–50% down to 4%–10% [2, 3, 6].
The use of modern circular staplers, making anastomoses possible in the deep pelvis, as well as the widespread belief that 1–2 cm of safety distance to the distal border of the tumor are sufficient enough from an oncological point of view [2, 13, 22], have increased our ability to cure more and more low rectal cancers by sphincter-preserving low anterior resections [2]. Consequently, the interest in functional results after rectal reservoir reconstruction has increased significantly.
Colon J-Pouch
The straight coloanal anastomosis (CAA) had been the most commonly used technique until Lazorthes and Parcs described the colon J-pouch independently of each other in 1986 [15, 20]. Various randomized controlled trials have shown the superiority of the colon-J-pouch as a rectal reservoir reconstruction leading to better early functional results compared to the straight CAA [5, 10, 14, 23].
However, 30% of the patients with CJP faced late evacuation problems requiring the chronic use of enemas or laxatives [11, 18, 19]. This rate could be decreased by shortening the limb of the CJP from 8–10 cm to 5–6 cm, but the late evacuation problems remained in approximately 10% of the patients [7, 16]. Two years after the operation, no differences could be observed between CAA and CJP in terms of frequency, urge and incontinence [9].
Transverse Coloplasty Pouch
In 1999 a new technique for rectal reservoir reconstruction, the transverse colo- plasty pouch (TCP), was introduced by Z’graggen and Büchler.
It was developed to provide early functional results comparable to the CJP, but avoiding the problems of late evacuation [25–29].
The technique is very simple, as an anti-mesenteric longitudinal colotomy is performed at the cut end of the descending colon. The incision should be 8 cm long, starting about 2 cm proximal to the rim of the anvil of the stapler. Stay sutures are placed 6 cm above the rim of the anvil lateral of both teniae, the pouch is then created by lateral traction of these sutures. Afterwards the colotomy is closed by transverse running sutures, starting from the pouch corners.
The importance and impact of this new technique in the surgical community
is highlighted by the fact that, according to a Medline search, already 16 papers,
including one randomized controlled trial, were published between 1999 and Oc-
tober 2003, with more to come.
CJP Versus TCP
The results of the first randomized controlled trial comparing the CJP with the TCP in terms of complications and functional results were published by Ho et al. in 2002 [10]. Forty-four patients received a CJP or TCP, respectively, after low anterior resection stemming from rectal cancer. Only minimal differences in the bowel function were observed 1 year after the operation between the two groups;
however, significantly more anastomotic leaks were seen in the TCP group (15.9%
vs. 0%, p=0,0121). Four of the seven patients with an anastomotic leak in the study from Singapore were asymptomatic, resulting in an symptomatic leakage rate of 6.7% [10]. The authors concluded that the CJP remains the benchmark of pouch reconstruction after low anterior resection.
Is this statement according to the currently available literature really undis- putable?
TCP and Anastomotic Leakage
Z’graggen and Büchler reported in the first prospective phase I/II study, which included 41 patients with TCP after low anterior resection, an anastomotic leakage rate of 7.3% (3/41 patients) [27]. In a recently published study from Heidelberg, looking at the early postoperative results after 82 TCPs between October 2001 and May 2003, anastomotic leakages were seen in seven patients (8.5%). Two of the seven patients had only radiological leaks without clinical signs, as all patients received a protective loop ileostomy for at least 3 months [24]. Four months later (October 2003), the anastomotic leakage rate dropped to 7.5% (see Sect. 2.2).
In comparison, anastomotic leakage rates in a range of 0%–10% have been reported for the CJP. The leakage rates of the TCP in our own two series and of others fall within these limits [4, 5, 7, 9, 12, 17, 21]. Fürst et al. and Pimentel et al. came to the same conclusion when they published their preliminary results of a randomized controlled trial comparing CJP and TCP. No significant difference was observed between the two groups in terms of anastomotic leakages [4, 5, 21].
Early Postoperative Results After TCP
Between October 2001 and the end of September 2003, we performed 180 low anterior resections due to rectal cancer: 106 patients received a TCP. The patient data is shown in Table 1.
The median operation time was 260 min, the median blood loss was 600 ml with in median no transfusions (range, 0–12), the median hospital stay 12 days (range, 7–48). The postoperative results are shown in Table 2. Three patients died within the first 60 days (3%), one patient due to pulmonary embolism, the other two patients due to aspiration pneumonia.
Twenty-four patients (23%) developed surgical complications such as anas-
tomotic leakage, bleeding, wound infection and voiding problems, five patients
TCP (n=106) Range
Age (median, years) 60 39–89
Male:female 76:30
Tumor above anal verge (cm) 7 3–12
Preoperative radiotherapy (5×5 Gy)a 30 (28%)
Preoperative radiochemotherapy 22 (21%)
aSince February 2002.
Table 2. Postoperative results
TCP (n=106) n %
Mortality (within 60 days) 3 3
Morbidity 29 27
Anastomotic leakage 8 7.5
Bleeding 2 2
Wound infection 8 7.5
Voiding problems 10 9
Cardiopulmonary complications 5 5
Reoperation 9 8
cardiopulmonary complications. Reoperations had to be performed in nine cases (8%) due to anastomotic leakages or bleeding (Table 2).
Functional Results after TCP
All studies published so far showed comparable early functional results for stool frequency, soiling, passing flatus, the ability to discriminate flatus from feces, need of antidiarrheal drugs, tenesmus and incomplete evacuation between the TCP and CJP reconstruction [10, 17, 21, 27].
To assess the bowel function after TCP, we sent a questionnaire to 106 patients.
Seventy patients (66%) with a median follow-up of 11 months (range, 2–22 ) returned the completed questionnaire and stated a mean of three bowel movements per day (range, 1–10); 14% of these patients complained about incontinence for liquid stool, 28% about stool fragmentation, 41% could discriminate between flatus and feces. Overall, 76% of the patients were satisfied with their bowel function.
The interpretation of these data is still difficult, as the follow-up of each patient
was different and very often rather short. Bowel function 1 year after closure of
the ileostomy will give more valid data.
CJP Versus TCP
To compare the new TCP technique with the gold standard technique of CJP, we started a single-center randomized controlled trial in October 2002. The objectives were to compare the two pouch reconstruction techniques in terms of morbidity, mortality and functional results. The sample size was calculated with 65 patients in each group.
As of October 2003, 59 patients were screened and 46 patients enrolled in the study. Twenty-two patients were randomized to the CJP, the other 24 patients to the TCP. The baseline characteristics of the patients are shown in Tables 3 and 4.
No significant differences were seen in terms of median age, gender ratio, preoperative treatment modalities, tumor stage and height of the tumor above the anal verge.
This data shows that the randomization worked. However, the small number of patients included so far and the short follow-up are not adequate for preliminary results at the moment.
Table 3. Baseline characteristics of the randomized controlled trial CJP vs. TCP
CJP (n=22) TCP (n=24)
Age (mean, range) 60 (46–76) 59 (39–78)
Male:female 15:7 16:8
Preop RT (5×5 Gy) 14 10
Preop RCT 4 2
RT, radiotherapy; RCT, radiochemotherapy.
Table 4. Baseline characteristics of the randomized controlled trial CJP vs. TCP
CJP (n=22) TCP (n=24)
UICC I 7 9
UICC II 8 6
UICC III 5 6
UICC IV 1 1
Adenoma 1 2
Tumor above anal verge (cm) 7 7
Conclusion
In conclusion, the TCP proved to be a safe method with low complication rates
and anastomotic leakage rates within the limits of rates published for the CJP. The
favorable early and late functional results, the technically easy and time-saving
surgical procedure and the low morbidity and mortality rates make the TCP a good
necessary to determine the indications for various pouch procedures in the future.
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