doi:10.1111/codi.12491
Systematic review
To drain or not to drain extraperitoneal colorectal anastomosis? A systematic review and meta-analysis F. Rondelli*†, W. Bugiantella*, M. C. Vedovati‡, R. Balzarotti§, N. Avenia†, E. Mariani*, G. Agnelli‡ and C. Becattini‡ *“San Giovanni Battista” Hospital, Foligno, Perugia, Italy, †Department of Surgery, School of Medicine, University of Perugia, Perugia, Italy, ‡Division of Internal and Cardiovascular Medicine and Stroke Unit, Department of Internal Medicine, School of Medicine, University of Perugia, Perugia, Italy and §“Bellinzona e Valli” Regional Hospital, Bellinzona, Switzerland Received 18 June 2013; accepted 30 September 2013; Accepted Article online 19 November 2013
Abstract Aim Anastomotic leakage is the one of the most serious complications in rectal cancer surgery and is associated with high mortality, morbidity and an increased incidence of local recurrence. Although many studies have compared drained and undrained colorectal anastomoses, to date the role of pelvic drainage in extraperitoneal colorectal anastomosis remains undefined. Method We carried out a systematic review of the literature, performing an unrestricted search in MEDLINE and Embase up to 30 October 2012. Reference lists of retrieved articles and review articles were manually searched for other relevant studies. We performed a meta-analysis of the data currently available on the incidence of extraperitoneal anastomotic leakage, according to the presence or absence of pelvic drainage. Results Overall, eight studies – three randomized clinical trials (RCTs) and five non-RCTs, comprising a total
Introduction Anastomotic leakage is one of the most serious complications of rectal cancer surgery as it is associated with high mortality, morbidity and local recurrence [1–3]. Many factors influence the incidence of colorectal anastomotic leakage: the patient (sex, age, body mass index and comorbidities); the disease (malignant or benign, distance of the tumour from the anal verge, local extension and preoperative chemo/radiotherapy); and surgical variables (urgent or elective procedure, intraoperative bleeding, blood transfusions, adverse intraoperative events, rectal washout, protective stoma and drainage of the pelvic fossa) [4–7]. The role of pelvic Correspondence to: Walter Bugiantella MD, “San Giovanni Battista” Hospital, AUSL Umbria 2, Via M. Arcamone, 06039, Foligno, Perugia, Italy. E-mail:
[email protected]
of 2277 patients – were included in the meta-analysis. Pelvic drainage was demonstrated to reduce both the leak rate and the rate of reintervention in patients who underwent anterior rectal resection with extraperitoneal colorectal anastomosis (OR = 0.51, 95% CI: 0.36–0.73; and OR = 0.29, 95% CI: 0.18–0.46, respectively) compared with patients without drainage. Overall mortality and infection rates were also evaluated, but a nonsignificant correlation was found with the presence of drainage. Conclusion The meta-analysis shows that the presence of a pelvic drain reduces the incidence of extraperitoneal colorectal anastomotic leakage and the rate of reintervention after anterior rectal resection. Keywords Drainage, colorectal anastomosis, leakage, extraperitoneal, surgery
drainage in reducing the incidence of extraperitoneal anastomotic colorectal leakage is uncertain. In the perioperative period, blood and fluids preferentially collect in the pelvis because of its depth and its negative internal pressure [8]. The large empty space remaining after total mesorectal excision (TME), the absence of a peritoneal surface in the pelvic fossa and reactive tissue hyperaemia after preoperative radiotherapy are the main causes of the increased risk of extraperitoneal fluid collection [9–11]. The rationale for prophylactic pelvic drainage is to allow rapid evacuation of postoperative fluid collections, thus avoiding potential contamination. Drainage also allows early detection of a dehiscence. These interventions may prevent the need for additional surgical or percutaneous procedures. The risks of intra-abdominal drainage have been widely described: bowel perforation
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and vessel lesions as a result of decubitus or excessive suction; creation of a potential site of entry for infection; insufficient detection of a neighbouring leak; organ and vessel lesions during drain removal; and pain on drain removal [12]. Three types of drainage can be used in the pelvis: suction-free; suction; and irrigationsuction. The first two are used most widely; irrigationsuction drainage is less widely used as it does not provide satisfactory results [13]. Moreover, irrigationsuction drainage is the most difficult type of drainage to manage after surgery. Several authors have demonstrated that drainage reduces the incidence of colorectal anastomotic leak, whereas others have reported no clear benefit [7,11]. To date, randomized clinical trials (RCTs) and cohort studies have analysed the role of drainage in colorectal anastomosis [8–11], but only a few authors have distinguished between intraperitoneal and extraperitoneal colorectal anastomosis [7,9,10]. We carried out a systematic review of the literature and performed a meta-analysis of the data currently available on the incidence of extraperitoneal anastomotic leakage, according to the presence or absence of pelvic drainage [14–21]. The main purpose of our meta-analysis was to determine whether the use of a pelvic drain after extraperitoneal colorectal anastomosis is useful in preventing (and/or treating) an anastomotic leak.
Method We performed a systematic review and a meta-analysis on the benefit of pelvic drainage in patients undergoing elective rectal resection with TME and extraperitoneal colorectal anastomosis. A protocol was prospectively developed, detailing the specific objectives, criteria for study selection, approach to assess study quality, outcomes and statistical methods. Study outcomes
The primary outcome of the study was to assess the incidence of anastomotic leakage in patients who underwent extraperitoneal colorectal anastomosis, with or without the placement of pelvic drainage. The secondary outcomes were overall mortality, re-intervention and wound-infection rates in the same population. The in-hospital follow-up was also considered. Search strategy and eligibility criteria
An unrestricted search was performed in MEDLINE and Embase up to 30 October 2012. Research criteria
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included the terms ‘drain’ and ‘colorectal’ and ‘surgery’. In addition, reference lists of retrieved articles and review articles were searched manually for other relevant studies. Two authors (FR and WB) independently performed the searches and reviewed all identified publications and abstracts for inclusion using predetermined criteria. In order to be included in this review, studies needed to report the following: number of patients drained and not drained; type of drainage used; and incidence of anastomotic leakage in the two subgroups of patients. Disagreements were resolved by consensus with a third investigator (MCV) and by discussion. Data extraction and quality assessment
Data from the included studies were extracted independently by two authors (FR and WB) and were confirmed by both. The following individual data were extracted for each study using standardized extraction forms: general data (study design, year); characteristics of patients (number, age, gender, indication to colorectal surgery, height of the tumour and preoperative radiation); main features of the interventions (preoperative bowel preparation, surgical technique, type and height of the anastomosis, type of drainage and covering stoma); and clinical outcome (anastomotic leakage, re-intervention, death, infections and hospital stay). The Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group checklist was used [22]. The quality of RCTs was evaluated using a modified Jaded scale [23]. The quality of cohort studies was evaluated using the Newcastle–Ottawa quality assessment scale [24]. Selection of studies for meta-analysis
Data on patients with/without study outcomes and with the presence/absence of pelvic drainage were required to be included in the meta-analysis, thus allowing the creation of a 2 9 2 table. Statistical analysis
Meta-analyses of all outcomes were reported using fixed-effects models in the event of absence of significant heterogeneity. Outcomes are reported as randomeffects models when heterogeneity is present. Cochran’s v2 test and the I2 test for heterogeneity were used to assess between-study heterogeneity. Statistically significant heterogeneity was considered to be present when P < 0.10 and the I2 value was > 50% [25]. Pooled ORs were reported with 95% CIs. Cells including zero were
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replaced with 0.5. Publication bias was visually assessed using funnel plots [26]. Analyses were performed using REVIEW MANAGER 5.1 (The Cochrane Collaboration, Oxford, UK) and STATA/SE 12 (StataCorp LP, College Station, Texas, USA).
Results Overall, 505 studies were identified, 23 were suitable for systematic review and eight met the inclusion criteria. The flow diagram for inclusion is shown in Fig. 1. Three studies are RCTs, one has a prospective design and four are retrospective. A minimum of 59 and a maximum of 924 patients were included in the studies. The general characteristics of the study populations are shown in Table 1.
with pelvic drainage than in patients without pelvic drainage (OR = 0.42; 95% CI: 0.28–0.62; I2 = 3%). No publication bias was shown. The meta-analysis of the eight studies overall shows a lower incidence of extraperitoneal colorectal anastomotic leakage in patients with drainage than in patients without drainage (OR = 0.51; 95% CI: 0.36–0.73; I2 = 27%) (Fig. 2). A significantly lower rate of re-intervention was found in the group with drainage than in the group without drainage (OR = 0.29; 95% CI: 0.18–0.46; I2 = 0%): four studies [16–18,20] including 1289 patients (Fig. 3). In three studies (309 patients) [14,16,18], overall mortality and infection rates were also evaluated but a nonsignificant correlation was found with the presence of drainage (OR = 0.67; 95% CI: 0.20–2.23; I2 = 0% and OR = 1.24; 95% CI: 0.45– 3.40; I2 = 28%, respectively).
Meta-analysis
The results from the meta-analysis of the three RCTs (carried out on 291 patients) [14–16] demonstrates that the incidence of extraperitoneal colorectal anastomotic leakage does not differ in drained and undrained patients (OR = 0.98; 95% CI: 0.49–1.99; I2 = 0%). The meta-analysis of the five non-RCTs (carried out on 1986 patients) [17–21] shows a lower incidence of extraperitoneal colorectal anastomotic leakage in patients
Discussion This meta-analysis investigated the role of prophylactic pelvic drainage in extraperitoneal colorectal anastomosis, as reported in three RCTs and five non-RCTs with a total of 2277 patients. The pooled data from the RCTs and the non-RCTs show that pelvic drainage significantly reduces the incidence of colorectal anastomotic leakage. These results are supported by the data from
505 studies identified by computerized search 482 excluded by review of title and abstract: 471 not reporting data about colorectal anastomosis drainage 11 reviews and meta-analysis
23 suitable for systematic review 18 not reporting sufficient data
5 suitable for meta-analysis
9 retrieved by hand searching 6 not reporting sufficient data
Figure 1 Flow diagram of included studies.
8 meta-analysed
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Sagar et al. [14]
Scott et al. [17]
Merad et al. [15]
Sica et al. [18]
Brown et al. [16]
Yeh et al. [19]
Peeters et al. [20]
Akiyoshi et al. [21]
Year Study design Patients Total (M/F) Drain (M/F) No drain (M/F) Age Median Drain/No drain Indication Preparation Technique Anastomosis
1994 RCT
1996 Retrospective
1999 RCT
2000 Retrospective
2001 RCT
2005 Retrospective
2005 Retrospective
2011 Prospective
132 63 69
150 (85/65) 95 (54/41) 55 (31/24)
393 125 268
924 (570/354) 792 195
363 (223/140) 268 95
NA
64
NA
Cancer All Open Hand-sewn/ Stapled Discretion Suction
Cancer NA Open NA
Cancer NA Laparoscopic Stapled
Discretion Suction-free
Discretion Suction/ Suction-free Discretion 62 (4.8%) 301 (3.3%)
Drain Type of drain
100 (50/50) 52 (28/24) 48 (22/26) 61 64/58 All All Open Hand-sewn/ Stapled Randomised Suction
Covering stoma None Yes (% leak) No (% leak) Preoperative chrt None Yes (% leak) No (% leak) Leak% (tot/clin+rad) Drain 13.5% (7/5 + 2) No drain 10.4% (5/2 + 3) Reintervention% (n) Drain NA No drain Mortality% (n) Drain 5.8% (3) No drain 6.2% (3) Infections% (n) Drain 5.8% (3) No drain 0 Hospital stay% (n) Drain 13 No drain 11
156 (97/59) 111 (65/46) 45 (32/13) 65 66/65 Cancer All Open Hand-sewn/ Stapled Discretion Suction Discretion 27 (7.4%) 129 (4.6%) None
NA All All Open Hand-sewn/ Stapled Randomised Suction Discretion NA
69 69/68 Cancer All Open Hand-sewn/ Stapled Discretion Suction/ Suction-free None
None
59 (36/23) 31 (20/11) 28 (16/12) 65 66/64 Cancer All Open Stapled Randomized Suction Discretion 41 (NA) 18 (NA) None
Discretion
Discretion 523 (8.2%) 401 (16.0%)
None
NA
459 (10.9%) 465 (12.3%)
28 (7.1%) 335 (3.3%)
5.4% (6/5 + 1) 4.4% (2/2 + 0)
12.7% (8) 11.6% (8)
4.2% (4/3 + 1) 5.4% (3/3 + 0)
9.7% (3/2 + 1) 17.9% (5/3 + 2)
OR (95% CI) 2.15 (0.13–34.69)
9.6% (76) 23.5% (31)
2.6% (7) 6.3% (6)
1.8% (2) 4.4% (2)
NA
3.2% (3) 5.4% (3)
0 0
NA
6.1% (56) 15.4% (30)
NA
NA
NA
1.0% (1) 3.6% (2)
3.2% (1) 3.6% (1)
NA
NA
NA
NA
NA
2.1% (2) 5.4% (3)
16.1% (5) 10.7% (3)
NA
NA
NA
NA
NA
11 15
NA
NA
NA
NA
clin+rad, clinical and radiological; chrt, chemoradiotherapy; F, female; M, male; NA, not available; RCT, randomized clinical trial; tot, total.
F. Rondelli et al.
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Table 1 General characteristics of the study populations.
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F. Rondelli et al.
Study or subgroup
log (OR)
SE Weight
OR
OR
IV, Fixed, 95% CI
IV, Fixed, 95% CI
2.3.1 RCT Brown 2001 [16]
–0.7133 0.7622
5.4%
0.49 (0.11–2.18)
Merad 1999 [15]
–0.1044 0.5337
10.9%
1.11 (0.39–3.16)
0.2927 0.6297
7.8% 24.1%
1.34 (0.39–4.60) 0.98 (0.49–1.99)
Sagar 1995 [14] Subtotal (95% CI)
Heterogeneity: c2 = 1.13, d.f. = (P = 0.57); I 2 = 0% Test for overall effect: Z = 0.04 (P = 0.96) 2.3.2 no RCT Akiyoshi 2011 [21]
–0.9217 0.5697
9.6%
0.40 (0.13–1.22)
Peeters 2005 [20]
–1.0498 0.2369
55.4%
0.35 (0.22–0.56)
0.8338
4.5%
1.23 (0.24–6.30)
4.9%
0.76 (0.16–3.61)
1.5% 75.9%
2.15 (0.13–35.56) 0.42 (0.28–0.62)
100.0%
0.51 (0.36–0.73)
0.207
Scott 1996 [17]
–0.2744 0.795
Sica 2000 [18] Yeh 2005 [19] Subtotal (95% CI)
0.7655 1.4315
Heterogeneity: c2 = 4.12, d.f. = 4 (P = 0.39); I 2 = 3% Test for overall effect: Z = 4.31 (P < 0.0001) Total (95% CI) Heterogeneity:
c2
= 9.57, d.f. = 7 (P = 0.21);
I2
= 27%
0.1 1 0.01 Favours experimenetal
Test for overall effect: Z = 3.78 (P < 0.0002)
10 100 Favours control
Test for subgroup differences: c2 = 4.32, d.f. = 1 (P = 0.04); I 2 = 76.9% Figure 2 The pooled data from randomized clinical trials (RCTs) and non-RCTs show that the incidence of extraperitoneal colorectal anastomotic leakage is lower in drained patients. These results are supported by the data from non-RCTs.
Study OR 95% CI)
ID
Events,
Events,
%
treatment
control
weight
Brown 2001 [16]
0.90 (0.02–47.00)
0.5/31
0.5/28
0.94
Peeters 2005 [20]
0.26 (0.16–0.42)
56/792
30/132
87.24
Scott 1996 [17]
0.39 (0.05–2.89)
2/111
2/45
5.10
Sica 2000 [18]
0.57 (0.11–2.90)
3/95
3/55
6.72
Overall (I 2 = 0.0%, P = 0.738)
0.29 (0.18–0.46) 61.5/1029 35.5/260 100.00
0.0173
1
57.8
Figure 3 The rate of re-intervention is lower in patients with drainage than in those without drainage.
non-RCTs. However, the subgroup analysis of RCTs only did not show any benefit for the use of pelvic drainage.
Risk factors for dehiscence of a colorectal anastomosis have been described: male sex, smoking habit, bowel preparation, height of the anastomosis, level of tumour
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and presence of a protective stoma [1,20,27–29]. However, the roles of other potential risk factors (preoperative radiotherapy, type of anastomosis, intra-operative bleeding, perioperative blood transfusions, splenic flexure mobilization, body mass index, preoperative preparation, nutritional status, length of surgery, corticosteroid therapy and pelvic drainage) are still being investigated [1,9,30,31]. Given such a high number of risk factors, it is difficult to find homogenous data to include in a meta-analysis, as patients may differ regarding several variables, including type of anastomosis, type of drain utilized and the presence of a protective stoma. The value of prophylactic drainage in colorectal surgery has been well investigated in four meta-analyses [7,8,10,11], but only two [9,10] specifically evaluated extraperitoneal colorectal anastomosis; moreover, as these meta-analyses included two RCTs only, the number of patients was particularly limited (191). Three factors must be considered when analysing the role of pelvic drainage: the type of drain (suction-free, suction and irrigation-suction); the indication for placement; and the end-point for removal. The option selected in each of these factors is often at the surgeon’s discretion and thus may vary, not only between different studies but also within the population of a single study. Accordingly, it is very difficult to find homogeneity. In addition, published studies show that the outcome with the irrigation-suction drain seems to be worse than the outcomes with the suction and suction-free drains, probably because the irrigation-suction drain is more difficult to manage [13]. Therefore, we considered only data describing the use of suction and suction-free drainage. The meta-analysed studies were sufficiently homogeneous regarding population, preoperative bowel preparation, operative technique, height and type of colorectal anastomosis and type of pelvic drain employed. It was not possible to evaluate the incidence of leakage according to the height and the type of the colorectal anastomosis, the surgical approach and the presence of a protective stoma in patients with or without pelvic drainage because data on these subgroups of patients were not available in the studies. Moreover, it was not possible to establish the end-point of every single factor before drain removal. These are the intrinsic limits of meta-analyses, which combine heterogeneous data sets and do not often allow adjustment for confounders. This might be feasible for a patient-level meta-analysis, but data on individual patients were not available in the present study. The percentage of leakage does not seem to rely on the type of anastomosis performed: hand-sewn vs stapled, as evidenced by the meta-analysis performed by Neutzling et al. [32]; and end-to-end vs side-to-end, as
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shown by Tan et al. [33] and Matthiessen et al. [1]. Moreover, open and laparoscopic surgical approaches have shown similar safety (morbidity and mortality within 28 days) and completeness of resection, as shown in the RCT of van der Pas et al. [34]. However, the results of the meta-analysis performed in the present study did not change when the study on laparoscopic rectal resections (Akiyoshi et al. [21]) was not included (OR = 0.53; 95%: CI: 0.37–0.76; I2 = 36%). Although the time-period for selection of studies ranged from 1994 to 2011, the subanalysis of the papers divided by publication year (before 2000/after 2000) did not show statistically significant differences (P = 0.008; I2 = 85.9%). In six studies placement of a protective stoma was performed at the surgeon’s discretion, whereas it was never performed at all in two studies. Even if it was not possible to abstract the features and the information about the correlation between drain and leak in patients who underwent faecal diversion, we can reasonably consider that this did not invalidate the meta-analysis. Preoperative radiotherapy was administered to several patients in two of the studies included in the meta-analysis. We consider that this did not alter the results of the meta-analysis because radiotherapy as a risk factor for anastomotic leakage has not, as yet, been demonstrated [1,9,30,31]. The decision to leave the drain in is a paramount issue: it was randomized in RCTs, but the decision was at the surgeon’s discretion in non-RCTs. Although not explained in individual papers, we believe that the decision to drain or not to drain in observational studies was mainly based upon the personal experience of the surgeon and the occurrence of intra-operative complications such as bleeding, vascularization of the left colon and the rectal stump and technical difficulties in performing an anastomosis. This might have influenced the final results, although it should be noted that a favourable outcome was reported for drainage. Therefore, even in complicated surgery, leaving the drain in could result in a better clinical outcome. Complicated patients (those with inadequate haemostasis and those with faecal peritoneal contamination) were excluded from two of the three RCTs. Hence, the results of the meta-analysis of RCTs could apply mainly to patients not presenting the abovementioned intra-operative complications. The meta-analysis shows that the presence of pelvic drainage reduces the percentage of re-interventions required as a result of anastomotic leakage. In fact, prophylactic pelvic drainage, allowing rapid evacuation of postoperative fluid collections and thus avoiding potential contamination, may prevent damage of the anastomosis as it heals. Prophylactic pelvic drainage may also facilitate the detection and drainage of an early, and
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perhaps asymptomatic, dehiscence, thus avoiding potential worsening and the need for additional surgical or percutaneous procedures. A nonsignificant correlation was found between mortality and the presence of drainage; nonetheless, a tendency towards lower mortality was found in drained patients, therein confirming the negative impact of leakage on prognosis. The meta-analysis did not show significant differences in infection rates; however, we observed a tendency for a lower infection rate in patients without pelvic drainage, suggesting that drainage is a conduit for microbes and requires effective management in the postoperative period. The paucity of RCTs and their uncertain results are caused by the fact that the study populations are small and that the incidence of extraperitoneal colorectal anastomotic leakage is rather low (about 7–9%); therefore, accepting that pelvic drainage decreases or increases the risk of extraperitoneal colorectal anastomotic leakage by about 20% (to 5% or 11%, respectively), thousands of patients are needed to perform an adequately powered study [12].
2
3
4
5
6
7
Conclusion This meta-analysis shows that the presence of pelvic drainage is linked to a lower incidence of extraperitoneal colorectal anastomotic leakage and to a reduced rate of re-intervention after anterior rectal resection. These results emerge from the analysis of observational studies – the RCTs show no clear benefit of drainage. We assert that pelvic drainage is useful in preventing colorectal anastomotic leakage and in reducing the re-intervention rate, mainly in patients with intra-operative complications, but future RCTs need to be carried out on larger numbers of patients in order to confirm these findings.
8
9
10
11
12
Conflicts of interest None of the authors has conflicts of interest or financial ties to disclose.
13
Author contributions
14
RF and WB conceived and designed the study, acquired the data and drafted the article; VMC and BR analyzed and interpreted the data; NA and CB revised the article; EM and GA finally approved the article.
15
16
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17
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