Value of protective stoma in rectal cancer surgery/Znacaj protektivne stome u hirurgijikarcinoma rektuma.
During the last two decades there was an increased proportion of sphincter-saving procedures in rectal cancer surgery due to better staging, surgical technique, introduction of staplers and preoperative irradiation [1-4]. However, this has resulted in an increased number of patients exposed to the risk of anastomotic leakage (AL). AL is the most serious surgical complication in rectal surgery with incidence ranging from 1.5 to 23%. Most studies give leakage rates in the range of 9% to 12% [5-8] and the associated risk of postoperative mortality is between 6% and 22% . Since morbidity and mortality resulting from AL are considerable, the routine use of defunctioning stomas has been suggested for high-risk anastomosis. The aim of our study was to find out whether a protective stoma was capable of lowering the rate of clinical AL and to evaluate the rate of AL requiring re-surgery.
Material and Methods
All the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the 7th Revision of the Declaration of Helsinki from 2008.
This retrospective study included 149 consecutive patients with rectal cancer (within 15 cm from anal verge), who had undergone elective rectal resection with primary anastomosis between 2006 and 2010 at the Institute for Oncology of Vojvodina, Department of Surgical Oncology. Data on age, gender, stage of tumor, distance from the anal verge, histological grade, neoadjuvant treatment, type of anastomosis technique (single stapling vs. double stapling), complications, anastomotic leakage rate, duration of operation and hospital stay were collected.
Rectal cancer was defined as a tumor located within 15 cm of the anal verge. The distal resection margin was defined as the distance from the lowest border of the tumor to the distal mucosal end of the fixed specimen.
The patients with locally advanced rectal cancer were referred for neoadjuvant chemoradiation consisting of three field external beam radiation therapy in the total dose of 50.4 Gy in 25 fractions along with bolus infusion sensitizing chemotherapy 5-Fluorouracil (25 mg/[m.sup.2]/day) with leucovorin (20 mg/[m.sup.2]/day) administered on the 1st, 2nd, 10th, 11th, 20th and 21st day of irradiation. Surgery was conducted 8 to 12 weeks after completion of chemoradiation.
All rectal resections were performed by three trained colorectal surgeons who applied an open procedure and according to the principles of rectal cancer surgery as described in details elsewhere [8, 9]. The circular staplers used for the circular single stapled anastomosis (CSA) were Premium Plus CEEATM Stapler 29, 31 and 34 mm (Covidien). In the double stapled anastomosis (DSA), the rectal stump was closed with Contour(tm) Curved Cutter Stapler (Ethicon Endo-Surgery) and the anastomosis was created with the same circular staplers as in the CSA group. The doughnuts were always inspected for completeness. Anastomotic integrity was verified by transanal air insufflations with the pelvis filled with saline. Additional suturing of the "dog ear" or line of anastomosis was done only in cases with verified anastomotic defect. A pelvic drain was always used.
A protective covering colostomy was added in selected cases and according to the surgeon's preference. No differentiation of the stoma (e.g., ileostomy or colostomy) was undertaken. The usefulness of a protective stoma, in terms of the rate and severity of anastomotic leakage, was examined by comparing the early postoperative results of surgery with and without covering the stoma.
The definition of anastomotic leakage adopted in this study included the following: 1) lower abdominal pain with fever, leucocytosis, tenderness, tachycardia, increased white cell count and/or prolonged ileus after operation with pelvic collection adjacent to the anastomosis with demonstration of anastomotic leakage - by rectal examination, rectoscopy or imaging study; 2) gas, pus or fecal discharge from the drainage site or discharge of pus from the rectum. Anastomotic leakage requiring surgery was defined as a clinical leakage needing an unplanned re-surgery for anastomotic dehiscence.
The association of leakage and the protective stoma as an independent variable was studied by univariate analysis. The target criteria were anastomotic leakage requiring surgery and leakage overall. The following parameters were examined: continuous parameters (distance of the tumor from the anal verge, age, duration of operation), dichotomous parameters (gender, type of anastomosis (CSA vs. DSA) and provision of protective stoma) and ordinal parameters (American Society of Anesthesiologists (ASA), tumor stage). For the selection of the parameters, a stepwise approach was applied. P values less than 0.05 were considered statistically significant.
The SPSS for Windows version 16.0 software program was used for the statistical analyses.
A protective stoma was created in 47 (31%) patients out of 149 who were enrolled in this study. A stoma was created more frequently in males, i.e. 35% of the males (30/86) and 27% of the females (17/63) received a stoma (p=0,356). The patients' characteristics are summarized in Table 1.
After total mesorectal excision, the anastomosis was created using CSA or DSA technique. The preferred method for creation of rectal anastomosis was DSA, which was performed in 89 patients (60%). The incidence of incomplete anastomotic rings and/ or positive air test and their relation to anastomotic technique are presented in Table 2.
Clinical AL occurred in 6.7% of patients (10/149). AL occurred in 8.5% of the patients with a protective stoma (4/47) and in 5.9% of those without a protective stoma (6/102), which was not statistically significant (Table 3).
The median tumor level above the anal verge for the patients having AL was 7 cm (ranging from 5 to 10 cm). ASA score was 2 for five out of ten patients with AL (50%) and 3 for the remaining 50% of patients. Three patients did not have comorbidity and were otherwise healthy, while six had cardiovascular pathology and one had diabetes and cardiovascular pathology. Preoperative radiotherapy was performed in 70% of patients who later suffered from AL (7/10).
Nine patients who developed AL did not have any complications related to creation of anastomosis, while air test was positive in one patient. Surgery lasted significantly longer when a stoma had to be created than in case when it was not needed (p=0.024).
The overall rate of re-surgery due to postoperative surgical complications was 5.3% (8149) and in three cases this happened because of AL. All patients with a protective stoma and clinical anastomotic leakage were treated conservatively (0/4), compared to 50% of patients without a protective stoma who suffered anastomotic leakage and had to be reoperated (3/6).
The mean hospital stay in patients without AL was 9 days, while those who suffered an anastomotic leakage were discharged from hospital on the median day 14.5 (p=0.056).
The patients without a stoma stayed in hospital for 10 days (range 7-43) while the mean hospital stay for the patients with a stoma was 12 days (range 7-39), p=0.14.
The 30-day mortality rate was 0.7% (1/149).
The routine use of protective stoma in rectal cancer surgery is still under debate. First of all, there are no clear indications for creating a stoma after rectal resections. Secondly, what is better: colostomy or ileostomy?
There is no risk-free anastomosis and according to literature there are some factors that may cause a higher rate of AL. These are preoperative irradiation, male sex, obesity and level of anastomosis [10-12]. In these cases, the surgeon should always consider creating a protective stoma.
Other risk factors may be a low preoperative serum albumin level (lower than 3.5 g/dL), steroid use, intraoperative blood loss of 200 mL or more, comorbidity, increased duration of surgery (operative time of 200 minutes or more) and/or intraoperative transfusion requirement . No significant difference in the leakage rate between anastomosis created by single or double stapling technique was found by Radovanovic et al. in a randomized study .
A stoma does not prevent leakage, but it is capable of minimizing anastomotic complications and the rate of re-surgery [15, 16]. It is associated with better clinical outcome or even the absence of clinical signs of dehiscence. In our study, there were 4 patients with a protective stoma who developed clinical AL and all were treated conservatively, while 50% of patients (3/6) with AL without a stoma had to be reoperated. Karanjia et al. found in their retrospective study that the percentage of anastomotic leakage was 8.3% if protective colostomy was created and 17.7% in patients without a stoma . Poon et al. described an anastomotic leakage of 3.3% in the patients with a protective stoma and 12.6% in the patents without a protective stoma. In this study, 148 colorectal anastomosis were performed by using stapling technique . One of the most important randomized multicenter studies in this field is Norwegian RECTODES which has shown that a protective stoma significantly decreases the incidence of clinically significant anastomotic leakage . Unlike other studies, in this randomized multicenter study the surgeon was not the one who decided whether a protective stoma should be performed or not. Our study is observational, not a randomized trial, and there were no significant differences in the leakage rate between the groups of patients with and without a stoma but the rate of re-surgeries was largely different.
Creating a protective stoma itself may carry possible complications. In addition, it prolongs operative time as we have shown in our study. After the surgery, the patient needs to adjust to the new quality of life. Another possible outcome is stenosis of the anastomosis.
Branagan et al. included 1839 patients who had radical resection of colorectal cancer in their large retrospective study. There were 633 resections of rectum with 6.3% of AL in this group, the early postoperative mortality being 10% in the group with AL and 2% in the group without AL (p=0.014). They also showed a statistically significant difference in the local recurrences and 5-year overall survival rates between the patients with and without AL . This effect of creating a protective stoma and its influence on the local recurrence and 5-year overall survival was reported in several studies published during the last decades [20-22].
However, creating a protective stoma requires another surgery which carries significant risks of morbidity and mortality and it may involve the use of considerable medical and economic resources [23, 24]. The stoma closure-related mortality rate is around 0.5% [25, 26]. The stoma carries morbidity risk from its creation until the moment of its closure .
When creating ileostomy, the surgeon should be well aware of its complications, such as increased loss of electrolytes and liquid, irritation of the skin, and prolapse. In their meta-analysis with 1204 patients from 7 studies, Tilney et al. compared protective ileo and transversostomy . A statistically increased level of electrolyte loss was found when creating ileostomy, while the wound infection and postoperative hernia were detected in closing colostomy more often than ileostomy. Some differences were observed in other compared parameters, such as AL, operative time, duration of hospital stay, prolapse, quality of life, etc. but they were not statistically significant. Edwards et al. also showed in their study that there were no statistically significant differences in creating and closing ileo and colostomy; however, according to the surgeon's opinion, ileostomy closure carries a greater risk [29, 30]. To summarize, there are no big differences between protective ileo and colostomy, so the hospital protocol and the preference of the surgeon are crucial when deciding which stoma should be created.
Although it is the surgeon's preference whether to create a protective stoma after rectal resection, there are obvious high risk factors for anastomotic leakage in which a stoma should be placed. This includes preoperative irradiation, low anastomosis (below 7 cm from the anal verge), in the patients with serious comorbidities and in cases of incomplete stapler's rings or positive air test. A stoma cannot prevent but it can surely minimize surgical complications related to anastomotic leakage and it does reduce the rate of re-surgeries.
Corresponding Author: Dr Ivana Fratrie, Institut za zdravstvenu zastitu dece i omladine Vojvodine, 21000 Novi Sad, Hajduk Veljkova 10, E-mail: email@example.com
CSA--circular single stapled anastomosis
DSA--double stapled anastomosis
ASA--American Society of Anesthesiologists
UDK 616.351-006.6-089.86-06 DOI: 10.2298/MPNS1604073F
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Rad je primljen 16. VII 2015.
Recenziran 18. XII 2015.
Prihvacen za stampu 28. XII 2015.
Ivana FRATRIC (1,2), Zoran RADOVANOVIC (1,3), Dragana RADOVANOVIC (1,3), Ferenc VICKO (1,3), Tomislav PETROVIC (1,3) and Zoran NIKIN (1,3)
University of Novi Sad, Faculty of Medicine (1) Institute for Child and Youth Health Care of Vojvodina, Novi Sad
Department of Pediatric Surgery (2) Institute for Oncology of Vojvodina, Department of Surgical Oncology (3)
Table 1. Patients' characteristics Tabela 1. Karakteristike bolesnika Total With Ukupno protective stoma Sa protektivnom stomom Number of patients operated 149 47 on/Broj operisanih bolesnika Mean age (range)/Srednja vrednost 65 (39-88) 65 (40-82) godina (rang) Gender/Pol male/muski 86 (57.7%) 30 (64%) female/zenski 63 (42.3%) 17 (36%) ASA/Americko udruzenje anesteziologa 1 8 (5.4%) 2 (4%) 2 81 (54.4%) 28 (60%) 3 60 (40.3%) 17 (36%) Number of patients with preoperative CRT Broj bolesnika 54 (36%) 26 (55.4%) sa preoperativnom hemioradioterapijom Number of patients with complete pathological response after CRT/Broj bolesnika sa kompletnom 4 (2.7%) 1 (2.1%) histoloskom regresijom nakon hemioradioterapije Stage/Stadijum 0 (Tis) 2 (1.3%) 1 (2.1%) I 45 (30.2%) 16 (34%) Ila 25 (16.8%) 8 (17%) IIb 2 (1.3%) 1 (2.1%) IIIa 9 (6%) 4 (8.5%) IIIb 30 (20.1%) 7 (14.9%) IIIc 20 (13.4%) 8 (17%) IV 12 (8.1%) 1 (2.1%) Length of procedure--mean, 132 (60-250 140 (90-250 min) range (min) Duzina trajanja min) procedure--srednja vrednost, rang (min) Tumor distance from anal verge, 8.2 (2-14cm) 6.6 (2-12) mean/range) Udaljenost tumora od analne linye, srednja vrednost, rang Clinical AL/Klinicki znaci 10 (6.7%) 4 (8.5%) popustanja anastomoze Re-surgeries due to AL/Reoperacije 0/4 (0%) usledpopustanja anastomoze 3/10 (30%) Re-surgeries (in hospital or 8/149 (5.3%) 2/47 (4.25%) <30 days) (due to AL and other complications)/Reoperac/je (unutar 30 dana) usledpopustanja anastomoze ili drugih komplikacija Mortality in hospital/Mortalitet 1 (0.7%) 0 tokom bolnickog lecenja No stoma Bez stome Number of patients operated 102 on/Broj operisanih bolesnika Mean age (range)/Srednja vrednost 64 (39-88) godina (rang) Gender/Pol male/muski 56 (55%) female/zenski 46 (45%) ASA/Americko udruzenje anesteziologa 1 6 (6%) 2 53 (52%) 3 43 (42%) Number of patients with preoperative CRT Broj bolesnika 28 (27.5%) sa preoperativnom hemioradioterapijom Number of patients with complete pathological response after CRT/Broj bolesnika sa kompletnom 3 (2.9%) histoloskom regresijom nakon hemioradioterapije Stage/Stadijum 0 (Tis) 1 (2.1%) I 29 (28.4%) Ila 17 (16.7%) IIb 1 (1.0%) IIIa 5 (4.9%) IIIb 23 (22.5%) IIIc 12 (11.8%) IV 11 (10.8%) Length of procedure--mean, 128 (60-185 range (min) Duzina trajanja min) procedure--srednja vrednost, rang (min) Tumor distance from anal verge, 8.9 (2-14 cm) mean/range) Udaljenost tumora od analne linye, srednja vrednost, rang Clinical AL/Klinicki znaci 6 (5.9%) popustanja anastomoze Re-surgeries due to AL/Reoperacije 3/6 (50%) usledpopustanja anastomoze 3/10 (30%) Re-surgeries (in hospital or 6/102 (5.9%) <30 days) (due to AL and other complications)/Reoperac/je (unutar 30 dana) usledpopustanja anastomoze ili drugih komplikacija Mortality in hospital/Mortalitet 1 (1%) tokom bolnickog lecenja Table 2. Relationship between type of anastomosis and complications in anastomotic integrity Tabela 2. Povezanost tipa anastomoze i komplikacija integriteta anastomoze Complications in anastomotic integrity Komplikacija integriteta anastomoze No complications Incomplete Bez komplikacija rings Nepotpuni prstenovi CSA/JSA 47 4 Type of (jednostaplerska anastomosis anastomoza) Tip DSA/DSA 89 1 anastomoze (dvostaplerska anastomoza) Total/Ukupno 136 5 Complications in anastomotic integrity Komplikacija integriteta anastomoze Air test positive Total Pozitivan test Ukupno insuflacije vazduha CSA/JSA 4 55 Type of (jednostaplerska anastomosis anastomoza) Tip DSA/DSA 4 94 anastomoze (dvostaplerska anastomoza) Total/Ukupno 8 149 Table 3. The rate of AL and the need for re-surgery in those patients Tabela 3. Ucestalostpopustanja anastomoze i neophodnost reoperacije Protective stoma/Protektivna stoma No/Ne Yes/Da Total/ Ukupno No/Ne 96 43 139 Anastomotic Yes--without 3 4 7 leakage Popustanje re-surgery Da--bez anastomoze reoperacije Yes--with re-surgery/ 3 0 3 Da--sa reoperacijom Total/Ukupno 102 47 149
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|Title Annotation:||ORIGINAL STUDIES/ORIGINALNI NAUCNI RADOVI|
|Author:||Fratric, Ivana; Radovanovic, Zoran; Radovanovic, Dragana; Vicko, Ferenc; Petrovic, Tomislav; Nikin,|
|Date:||Mar 1, 2016|
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