LAPAROSCOPIC COLORECTAL ANASTOMOSIS USING THE NOVEL CHEXTM
CIRCULAR STAPLER: A CASE-CONTROL STUDY.
Léon Maggiori, MD, Frédéric Bretagnol, MD, Marianne Ferron, MD, Yasmina Chevalier,
MD, Yves Panis, MD PhD
Department of Colorectal Surgery, Pôle des Maladies de l’Appareil Digestif (PMAD),
Beaujon Hospital (AP-HP), 100 boulevard du Général Leclerc, 92118 Clichy, France.
Original article
Address for correspondence and reprints :
Professor Yves Panis, MD, PhD, Service de Chirurgie Colorectale, Pôle des Maladies de
l’Appareil Digestif (PMAD), Hôpital Beaujon, 100 boulevard du Général Leclerc, 92118
Clichy cedex, France
(Tel +33 1 40 87 45 47 ; Fax +33 1 40 87 44 31 ; E-mail yves.panis@bjn.aphp.fr)
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ABSTRACT
Background. The widespread availability of circular stapling devices to perform colorectal
anastomosis has changed surgery especially in laparoscopy. The aim of this case-matched
study was to assess the safety and effectiveness of a new circular stapler in terms of operative
results and cost.
Methods. From May 2007 to March 2008, we prospectively included 30 patients who
underwent laparoscopic colorectal resection for colorectal cancer and/or benign disease, using
the CHEXTM circular stapler (APVL Medic’s, France - Frankenman, Suzhou China)
according to the “double stapling” technique. These patients were matched with 30 others
patients (from a review board-approved database) undergoing same operation with either
Covidien or Ethicon devices. Primary end-points were operative results. Surgeons were asked
to fill a specific questionnaire concerning the device ergonomia, using an analogic visual
scale. A cost-analysis was conducted.
Results. There were 30 patients with a mean age of 58 (20-88) years and a BMI of 26 (18-41)
kg/m2. Etiologies included colorectal cancer (n=13, 43%) and benign disease (n=17).
Laparoscopic procedures included left colectomy (n=24, 80%) and rectal excision with TME
(n=6). Two patients required conversion in laparotomy (7%). A temporary ileostomy was
performed in 14 patients (47%). Mortality was null. The overall morbidity rate was similar
between the two groups (30%). Four patients (13%) experienced clinical and/or asymptomatic
anastomotic leakage in both groups. Mean overall appreciation was scored 8.1/10 (3-9.5),
including best score for stapler removing (9.5). No major device failure was observed. There
was a trend toward lower overall cost per patient in the CHEX group.
Conclusion. This study suggests that colorectal anastomosis using the CHEXTM circular
stapler is safe without increasing the overall morbidity, especially in terms of anastomotic
leakage and is a cost-effective method.
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INTRODUCTION
The double-stapled technique, with the use of transanal circular stapled device is widely
used1-9. Moreover, more recently, the laparoscopic approach in colon and rectal surgery has
improved the widespread popularity of stapling devices.
Many studies have demonstrated the effectiveness and the safety of such stapling
procedure. A recent French prospective multicenter study concluded that colorectal surgery
was associated with a 5 to 6% of mortality rate and a 20 to 40% morbidity rate10.
Postoperative anastomotic dehiscence represented the main postoperative complication with
significant clinical implications. A Cochrane review comparing both procedures i.e. stapled
versus handsewn procedures for colorectal surgery was insufficient to demonstrate any
superiority of the stapling method over handsewing, regardless of the level of anatomosis11.
Therefore, besides good results, the major drawback of this procedure remains related to
the cost-benefit ratio1. Moreover, the higher costs of laparoscopic equipment require more
financial resources12. Despite the potential financial benefit in terms of improvements in
clinical recovery and shorter hospital stay after laparoscopic procedures, the use of intraoperative cost-effective device could be justified.
The aim of this study was to assess the safety and effectiveness of a new circular stapler
in terms of operative results and cost in colorectal surgery.
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PATIENTS AND METHODS
From May 2007 to March 2008, we prospectively included 30 patients who underwent
colorectal resection with sphincter preservation for colorectal cancer and/or benign disease,
using the CHEXTM circular stapler (APVL Medic’s, France – Frankenman, Suzhou China)
according to the “double stapling” technique introduced by Knight and Griffen9.
Surgical technique
The technique routinely involved for cancer (in both laparoscopic and open technique):
high ligation of the inferior mesenteric vessels, complete mobilization of the splenic flexure
and partial or total mesorectal excision according to rectal cancer location (i.e. 5 cm below
the lower edge of the tumour in the upper third of the rectum, and to the pelvic floor for mid
and low rectal tumour with total mesorectal excision (TME) and nerve preservation). For
benign disease, we usually dissect close to the colon and rectum with sigmoid vessels
ligation to avoid nerve injury. Then, the rectum was transected using an endoscopic linear
stapler and reconstruction was a transanal stapled colorectal anastomosis. The doughnuts
were always inspected for completeness. A colonic J-pouch or a side-to-end colorectal
anastomosis was performed with temporary fecal diversion for low anastomoses 6 cm or less
from the anal verge. Anastomotic integrity was tested during operation by transanal
instillation of fluid only for low anastomoses or if there were difficulties in performing the
anastomosis.
For laparoscopic patients, the surgical procedure was performed through a total
laparoscopic approach with only a 5-cm incision in the right iliac fossa for both specimen
extraction and temporary ileostomy.
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Comparative study
All patients undergoing colorectal resection in our department are currently included
prospectively into a review board-approved database. This database was used for the casematched study. Data collection included patients features (gender, age, body mass index
(BMI), American Society of Anesthesiology score (ASA score), diabetes mellitus, recent
steroid treatment, prior laparoscopy or laparotomy, cardiopulmonary comorbidity, neurologic
comorbidity and gastrointestinal comorbidity), disease features (diagnosis, TNM score for
colorectal cancer), the surgical procedure (urgent or elective procedure, type of colorectal
resection, anastomosis height, protective stoma, abdominal drainage, associated procedures
(including others organs resections), peritoneal contamination, technical operative
complications, and operative time), and the post operative results (mortality and morbidity).
Each patient of the CHEX group was manually matched with all identical patients from
the database, in whom another type of circular stapler was used, according to the individual
matching published by Miettinen et al.13. Matching criteria were sex, age, ASA grade,
diagnosis, colon or rectal surgery, temporary stoma and preoperative radiotherapy (for rectal
cancer patients).
End-points definition
The primary end-points were intra-operative and postoperative complications. Mortality
was defined as death occurring during the hospital stay or within 30 days. Clinical
anastomotic leakage was defined as being gas, pus or faecal discharge from the drain,
peritonitis, discharge of pus per rectum or rectovaginal fistula. Asymptomatic radiological
anastomotic leakage was considered in defunctioned patients because CT-scan with contrast
enema was systematically performed before stoma reversal. Major surgical morbidity was
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defined by the necessity of reoperation (peritonitis, haemorrhage, small bowel obstruction) or
drainage of abscess by radiologic methods.
Secondary end-point was surgeons’ satisfaction. Both surgeons (YP, FB) were asked to
fill a specific questionnaire about the use of the stapler (concerning general ergonomia, anvil
opening, anvil removing, shaft insertion, rectal stump perforation, anvil and shaft mating,
stapler closing, stapling, stapler removing, “donuts” quality and general appreciation), using
an analogic visual scale. Notations were from 0 to 10, increasing with the level of satisfaction.
Then, a cost-analysis was carried out, considering that, except use of an alternative circular
device, all the others costs were similar in both groups (i.e. laparoscopic devices, etc…).
Statistical analysis
Descriptive analyses (mean, standard deviation, median, and range) were performed, as
appropriate. Normally distributed quantitative data were analyzed with Student t test. Mann
Whitney U test was used otherwise. The level of statistical significance was set at p < 0.05
and tests were always 2-sided. Analysis was performed using Statistical Package for the
Social Sciences (SPSS, version 16.0, Chicago, IL, USA)
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RESULTS
Study group
There were 30 patients (21 female) with a mean age of 58 (range, 20-88) years and a
BMI of 26 (range, 18-31) kg/m2. The main indications for surgery were sigmoid diverticulosis
in 11 patients (37%) and colorectal cancer in 13 patients (43%), including mid or low rectal
tumors in 6 patients (20%) (Table 1).
Table 1. Demographics of patients
Gender (Male/Female)
CHEX stapler
group
n=30
Usual stapler
group
n=30
9/21
9/21
a
Age
p-value
1
a
58 ± 16 (20-88)
57 ± 13 (35-84)
a
a
0.4
BMI
26 ± 5 (18-41)
27 ± 5 (17-44)
0.77
ASA score
1.9 ± 0.5 (1-3)a
1.9 ± 0.4 (1-3)a
0.83
0.9
Diagnosis
Colorectal cancer
13 (43)b
13 (43)b
Diverticular disease
11 (37)b
13 (43)b
Ulcerative colitis
1 (3)b
1 (3)b
Colon volvulus
1 (3)b
0
Adenoma
Neo-adjuvant radio-chemotherapy
b
4 (14)
3 (10)b
6 (20)b
6 (20)b
1
Surgical procedure
Left Colectomy
Proctectomy with TME
b
b
24 (80)
24 (80)
b
6 (20)b
6 (20)
1
Surgical approach
Laparoscopy
Laparotomy
Diverting stoma
0.82
b
b
28 (93)
28 (93)
b
2 (7)
2 (7)b
14 (47)b
14 (45)b
1
Concerning the surgical procedures, a left colectomy with high colorectal anastomosis
was performed in 24 patients (80%) and 6 patients (20%) underwent rectal excision with
TME and low colorectal anastomosis. Two patients required conversion in laparotomy (7%),
one because of extra anatomical pelvic dissection for rectal tumor fixity (n=1) and the second
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for pneumoperitoneum intolerance (n=1). A temporary ileostomy was performed in 14
patients (47%) because of low colorectal anastomosis (< 6 cm from the anal verge) (n=6) or
local conditions (n=8).
Comparative study
Both groups (CHEX and usual stapler groups) were adequately matched. Postoperative
course was given in Table 2.
Table 2. Post-operative course
Mortality
Overall Morbidity
Overall anastomotic leakage
CHEX stapler
group
n=30
Usual
stapler group
n=30
p-value
0
0
1
9 (30)b
9 (30)b
1
b
b
4 (13)
4 (13)
1
2 (6)b
1 (3)b
0.55
Asymptomatic leakage
b
1 (3)
0
0.31
Rectovaginal fistula
1 (3)b
0
0.31
0
3 (10)b
Peritonitis
Isolated pelvic abscess
Medical morbidity
b
7 (23)
b
8 (27)
0.076
0.77
a: mean ± SD (range)
b: number of patients (percentage of patients)
There were no peri-operative deaths in both groups. The overall morbidity rate was
similar between the two groups (30%). Four patients (13%) experienced clinical and/or
asymptomatic anastomotic leakage in both groups including peritonitis requiring reoperation
in 2 patients (6%) in the CHEX stapler group and in 1 patient in the usual stapler group (3%)
(P=0.55). Peritonitis management consisted in laparotomy with peritoneal drainage and
preservation of the colorectal anastomosis in all cases.
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Concerning surgeons’ satisfaction about the use of the CHEX stapler, all 11 studied
items obtained a mean score ranged from 8 to 10 as detailed in Table 3. General appreciation
was scored 8.1  1.8 (3-9.5). No major device failure was observed during the study.
Table 3. Assessment of the use of the CHEX circular stapler.
Criteria
Score
General ergonomia
8.8  0.9 (5-10)
Anvil opening
8.6  1.3 (5.5-10)
Anvil removing
8  1.6 (2-9.5)
Device insertion
8.7  1.2 (5-10)
Rectal stump perforation
8.8  1 (4.5-10)
Anvil and shaft mating
8.4  1.7 (2-10)
Stapler closing
8.6  1.3 (4-10)
Stapling
9  0.6 (7-10)
Stapler removing
9.5.  1.9 (8-10)
Doughnuts assessment
8.7  1.3 (3-10)
General appreciation
8.1  1.8 (3-9.5)
Notations were from 0 to 10, increasing with the level of satisfaction.
Values expressed as mean ± SD (range)
DISCUSSION
The present study showed that stapled anastomosis using the CHEXTM circular device is
safe and convenient without increasing morbidity and mortality compared to other known
usual devices. The rate of postoperative pelvic sepsis was similar between the two groups.
Moreover, using this stapler could be a financially interesting alternative.
In the last years, advances in intestinal stapling devices have led to an increased
frequency of stapled bowel anastomoses. Many studies have evaluated the stapled versus
handsewn methods for colorectal anastomosis. The majority concluded to the insufficiency of
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evidence to demonstrate any superiority of a method over the other2, 3, 11. Therefore, stapled
technique presents a variety of benefits: better blood supply, reduced tissue manipulation, less
oedema, uniformity of sutures, and rapidity. These factors are believed to facilitate the
anastomosis healing without increasing the incidence of postoperative complications such as
anastomotic leak, prolonged ileus or stricture. In spite of this, anastomotic dehiscence remains
a significant complication of colorectal surgery. In a meta-analysis, the authors showed no
clinically relevant difference in mortality and anastomotic leakage rate between the two
methods3.
The only differences concerned patients with stapled anastomosis which were more
likely to experience intraoperative technical mishaps and postoperative strictures. In the
present study, the very short follow-up (9.3 (range 3-14) months) did not allow to evaluate
this latter risk. Therefore, no patients in the CHEX group developed an anastomotic stricture.
A systematic review of randomized controlled trials14, noted that stricture occurred to a
significant extent in patients undergoing colorectal stapled anastomosis, especially in infraperitoneal location. It has been hypothesized that there may be an overactive inflammatory
response, leading to stricture formation15. However, the majority was easily managed with
endoscopic dilatation or asymptomatic.
Moreover, technical problems occurred significantly more often following stapled
anastomoses. A technical mishap is generally defined as a misfiring, or a malfunction, rather
than any difficulty in completing the anastomosis. The main expected risk could be, as Mac
Rae et al. reported, significant morbidity in the stapled group after technical mishap3. In the
current study, no major device failure requiring was observed and the morbidity rate was
similar between the two groups. One patient in the CHEX group developed postoperative
rectovaginal fistula due to the interposition of the vagina wall during the stapled procedure,
but this complication was not due to the device itself. This patient required conversion in
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laparotomy because of a narrow pelvis with the necessity of extra-anatomical dissection for a
T4 rectal tumor.
The use of staplers for anastomosis in colorectal surgery has been questioned by the
French Society of Digestive Surgery (SFCD) in 20001. The authors recommended, as much as
possible, the routine use of handsewn method for cost reasons. Moreover, a systematic review
has shown that both techniques (stapler vs. handsewn) were effective, and the choice should
be based on personal preference3. This point highlights the financial aspect of stapling
methods. The question of cost is related to the length of the operative procedure, length of
hospitalization, price of sutures and value of devices used, among other factors. The Cochrane
analysis showed that when only the cost of the material used in the anastomosis was taken
into consideration, the stapler was more expensive11. The cost of an operative procedure,
however, must be analyzed within a wider context involving not only the monetary value of
the materials but also the value resulting from the ease of execution, total time consumed, cost
of complications related to the method employed, among other factors. Fingerhut et al
showed that the time taken to perform the anastomosis was significantly shorter in stapled
colorectal anastomoses2. This factor had a relative value when analyzed in isolation, i.e. when
not associated with the total length of the operative procedures or hospitalization of the
patient.
In the present study, we noted that the cost of the used device was lower in the Chex
group. An Italian study has evaluated the cost/benefit ratio of stapled anastomoses in
colorectal surgery on the basis of a 8 year experience taking into account the overall costs in
surgery as well as short term and long term benefits. With this aim, the surgical experience
was divided in two periods. Mechanical suturing was found to be superior based on the
average postoperative hospital stay which decreased from 20 to 14 days; temporary stomas
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which decreased from 62 to 25% and abdominoperineal resection for rectal cancer which
decreased from 60 to 41%16.
CONCLUSION
In conclusion, this control-case study has suggested that colorectal stapled anastomosis
using the CHEXTM circular device was safe with similar operative results compared to other
known devices. This procedure was also convenient with high surgeons’ satisfactory without
major failure and with lower economic cost. Further data with more follow-up is required to
assess long term post-operative course.
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REFERENCES
1.
Slim K, Panis Y, Perniceni T, Escat J. [Mechanical sutures in digestive surgery.
Guidelines of the French Society of Digestive Surgery]. J Chir (Paris) 2000; 137(1):512.
2.
Fingerhut A, Hay JM, Elhadad A, et al. Supraperitoneal colorectal anastomosis: handsewn versus circular staples--a controlled clinical trial. French Associations for
Surgical Research. Surgery 1995; 118(3):479-85.
3.
MacRae HM, McLeod RS. Handsewn vs. stapled anastomoses in colon and rectal
surgery: a meta-analysis. Dis Colon Rectum 1998; 41(2):180-9.
4.
Adloff M, Arnaud JP, Beehary S. Stapled vs sutured colorectal anastomosis. Arch
Surg 1980; 115(12):1436-8.
5.
Moreno Gonzalez E, Rico Selas P, Mansilla Molina D, et al. Results of surgery for
cancer of the rectum with sphincter conservation. A randomized study on instrumental
versus manual anastomosis. Acta Oncol 1989; 28(2):241-4.
6.
Cajozzo M, Compagno G, DiTora P, et al. Advantages and disadvantages of
mechanical vs. manual anastomosis in colorectal surgery. A prospective study. Acta
Chir Scand 1990; 156(2):167-9.
7.
Sarker SK, Chaudhry R, Sinha VK. A comparison of stapled vs. handsewn
anastomosis in anterior resection for carcinoma rectum. Indian J Cancer 1994;
31(2):133-7.
8.
McGinn FP, Gartell PC, Clifford PC, Brunton FJ. Staples or sutures for low colorectal
anastomoses: a prospective randomized trial. Br J Surg 1985; 72(8):603-5.
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13
9.
Griffen FD, Knight CD, Sr., Whitaker JM, Knight CD, Jr. The double stapling
technique for low anterior resection. Results, modifications, and observations. Ann
Surg 1990; 211(6):745-51; discussion 751-2.
10.
Alves A, Panis Y, Mantion G, et al. The AFC score: validation of a 4-item predicting
score of postoperative mortality after colorectal resection for cancer or diverticulitis:
results of a prospective multicenter study in 1049 patients. Ann Surg 2007; 246(1):916.
11.
Lustosa SA, Matos D, Atallah AN, Castro AA. Stapled versus handsewn methods for
colorectal anastomosis surgery. Cochrane Database Syst Rev 2001(3):CD003144.
12.
Noblett SE, Horgan AF. A prospective case-matched comparison of clinical and
financial outcomes of open versus laparoscopic colorectal resection. Surg Endosc
2007; 21(3):404-8.
13.
Miettinen OS. Individual matching with multiple controls in the case of all-or-none
responses. Biometrics 1969; 25(2):339-55.
14.
Lustosa SA, Matos D, Atallah AN, Castro AA. Stapled versus handsewn methods for
colorectal anastomosis surgery: a systematic review of randomized controlled trials.
Sao Paulo Med J 2002; 120(5):132-6.
15.
Dziki AJ, Duncan MD, Harmon JW, et al. Advantages of handsewn over stapled
bowel anastomosis. Dis Colon Rectum 1991; 34(6):442-8.
16.
Donini I, Mari C, Buccoliero F, et al. [Mechanical staplers in colorectal surgery: costbenefit ratio]. G Chir 1990; 11(9):463-5.
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