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 Table of Contents  
ORIGINAL ARTICLE
Year : 2018  |  Volume : 3  |  Issue : 3  |  Page : 180-186

To use closed suction drain or not after total hip arthroplasty; A randomized controlled trial?


Department of Orthopedic Surgery, Faculty of Medicine, Assiut University, Assiut, Egypt

Date of Submission02-Jan-2018
Date of Acceptance21-Jan-2018
Date of Web Publication14-Mar-2019

Correspondence Address:
David N Ghaly
Department of Orthopedic Surgery, Assiut General Hospital, Assiut
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/JCMRP.JCMRP_1_18

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  Abstract 

Aim
The aim of the study is to provide clinical evidence through an analysis of the pros and cons of using a closed-suction drain (CSD) system after primary total hip arthroplasty.
Patients and methods
We conducted a prospective, randomized, controlled trial in Assiut University Hospitals between February 2016 and July 2017. In all, 100 patients who underwent primary total hip arthroplasty (cemented and cementless) were enrolled and randomly allocated into two groups of 50 patients each: group A (patients had CSD) and group B (patients had no CSD). Patients with revision surgery, uncontrolled bleeding tendency, liver or renal impairment, and low preoperative hemoglobin (Hb) level less than 11 g/dl were excluded from the study. The primary outcomes were Hb reduction and the number of patients transfused and the volume of blood transfusion per patient. The secondary outcomes were evaluation of the wound [including early surgical site infection (SSI), wound discharge, need for dressing reinforcement, ecchymosis], time for operative procedure, and length of hospital stay.
Results
Hb reduction was more in the group of CSDs (group A: 3.01 g, group B: 2.57 g, P < 0.04*). The number of patients transfused was also more in the CSD group (group A: 37/50, group B: 26/50, P < 0.03*). The mean volume of blood transfused per patient was significantly higher in the CSD group (group A: 1.13 unit of blood, group B: 0.52 unit, P < 0.02*). Patients without CSDs show more wound discharge (group B: 36/50, group A: 33/50, P = 0.038*), more dressing reinforcements (group B: 2.02 dressing per patient, group A: 1.7, P < 0.03*), and more ecchymosis (group B: 30/50, group A: 23/50, P < 0.04*). No significant difference concerning time for surgical procedure, early SSI, or length of hospital stay.
Conclusion
CSD had a negative effect on Hb reduction and rate and volume of blood transfusion (more Hb reduction and subsequently more transfusion requirements), while it had a positive effect on wound condition (less wound discharge, less dressing reinforcements, less ecchymosis), and no effect regarding early SSI, time for surgical procedure, and length of hospital stay.

Keywords: closed-suction drain, hemoglobin reduction, total hip arthroplasty


How to cite this article:
Ghaly DN, Khalifa YE, Bakr HM, Mahran MA. To use closed suction drain or not after total hip arthroplasty; A randomized controlled trial?. J Curr Med Res Pract 2018;3:180-6

How to cite this URL:
Ghaly DN, Khalifa YE, Bakr HM, Mahran MA. To use closed suction drain or not after total hip arthroplasty; A randomized controlled trial?. J Curr Med Res Pract [serial online] 2018 [cited 2022 Jun 29];3:180-6. Available from: http://www.jcmrp.eg.net/text.asp?2018/3/3/180/254193


  Introduction Top


Closed-suction drains (CSDs) are commonly used by orthopedic surgeons in large joint arthroplasties to avoid the development of postoperative hematomas. This practice has been promoted since 1961 by Waugh and Stinchfield[1] and it was probably intended as a way to reduce the high risk of infection related to the use of open drainage.

The rationale for using CSD is to reduce the formation of wound hematoma that causes increased tension and decreased perfusion in the surrounding tissues, which could explain the final detrimental effect on wound healing and the likelihood of wound dehiscence and wound infection.

During the years this practice has become a standard of care in total joint replacement among orthopedic surgeons, despite the fact that many good-quality clinical studies failed to demonstrate any effect of CSD in preventing wound complications, thus questioning the indiscriminate use of CSD in total joint arthroplasties. On the other hand, some potential drawbacks have been associated with, which is considered a potential route for the entry of bacteria; as a prosthetic material it is able to compromise the natural host defenses and to act as a support for developing infection. In addition, a suction drain may increase the perioperative blood loss, diminishing the tamponade effect on the joint.

Finally, pain and discomfort at removal of the drain have been reported as well as cases of blockage and breakage of the drain tube, leading to reoperation[2].

The routine use of CSD in orthopedic surgery has therefore aroused much controversy, with recent studies indicating that this practice may be of more harm than good, and at an additional cost[3].

A recent meta-analysis conducted in 2013 of 3186 patients undergoing primary total hip arthroplasty (THA) showed that the use of CSD increased the rate of blood transfusion and did not provide any benefits regarding the incidence of infection, functional recovery, or other complications[4].

Koyano[5]in Japan said 'Studies that evaluated the effects of CSD using more specific parameters such as range of movement of the hip joint showed no difference between groups with CSD and without CSD'.

So we conducted this clinical trial to evaluate the use of CSD in primary THA and to determine whether it is beneficial or not.


  Patients and Methods Top


Study design

This study is a prospective, double-blind, randomized controlled trial conducted in a single center in which 100 patients underwent primary THA who were randomly allocated to two parallel groups of 50 patients each (clinicaltrials.gov research protocol registration ID: NCT02845427).

Devices to be used

(CSD; closed-suction drainage system).

Patient selection

Inclusion criteria

Primary THA (cemented and cementless).

Exclusion criteria

Revision cases: uncontrolled bleeding tendency (prothrombin concentration <70%), liver impairment (liver failure), renal impairment (serum creatinine >3 mg/dl), and preoperative hemoglobin (Hb) level of less than 11 g/dl.

Study methods

Preoperative clinical and laboratory assessment

Obtaining detailed history and full clinical examination, preoperative laboratory investigations (complete blood count) to determine the Hb level and assessment of renal function, coagulation, and bleeding profile preoperatively.

Method and timing of randomization

Permuted block randomization blocks having equal numbers of A and B (A: drain, B: no drain) are used. A sealed opaque envelope, in which instruction on whether to use drainage or not, will be opened just before wound closure by a nurse in the operative room. Patients were divided equally into two groups according to the letter withdrawn randomly.

Method of calculation of intraoperative blood loss

Intraoperative blood loss was quantified by measuring the irrigation fluid and the number of surgical packs (towels) used to dry the field intraoperatively by the researcher plus the amount of blood in the intraoperative suction drain.

The surgical towel used measures 20 × 25 cm. It loads about 50 ml blood when it is partially soaked with blood and about 80 ml blood when fully soaked with blood.

Postoperative anticoagulant protocol

The use of anticoagulation (all patients will receive Enoxparin 'Clexane' (USA) subcutaneous injection/24 h for thrombosis prophylaxis, dose as follows: body weight >60 kg will receive 0.4 ml, 50–60 kg will receive 0.3, >50 kg will receive 0.2 ml) started 12 h postoperatively, and continued till discharge where it is shifted to oral anticoagulants.

Methods of evaluation of postoperative blood loss

A suction drain was placed in group A cases and the blood volume was recorded at 24 h when it was removed.

Methods of postoperative evaluation and follow-up

In all the patients included in this study, no intraoperative blood transfusion was done. If the anesthetist found that it was necessary (due to excessive bleeding), the patient was excluded from this study. All patients had Hb levels tested on the first and second postoperative days to evaluate the need for blood transfusion. Blood transfusion was given if the Hb level is less than 8 g/dl as recommended by Lee et al.[6]. The early reduction in Hb level was defined as the difference in Hb between the preoperative value and the postoperative sample taken 24 and 48 h after surgery.

Checking wound condition to detect any [discharge, ecchymosis, soaking of dressing, and need for reinforcement or any early surgical site infection (SSI)] at 24 h postoperatively (when the drain is removed), 48 h, 72 h, 15 days (when stitches are removed) and 30 days postoperatively.

Documentation of the amount of blood transfusion during the first 72 h postoperatively, any postoperative complications, and length of hospital stay.

Ethical approval

An approval for the study is obtained from the ethics committee in the Faculty of Medicine in Assiut University Hospitals, Assiut University. Informed consent was obtained from all patients included.

Statistical analysis

Expressed as mean, SD, number, and percentage. Data collected and analyzed by computer program SPSS 'version 23' (SPSS Inc., Chicago, Illinois, USA). t-Test (and Mann–Whitney if necessary) was used to determine significance for numeric variables. χ2-Test and Fisher's exact test were used to determine significance for categorical variables.


  Results Top


Demographic data of the study groups: there was mean value of age 48.25 years in group A versus 43.60 years in group B with nonsignificant difference. Also there was nonsignificant difference (P > 0.05) with sex and side [Table 1].
Table 1: Demographic data of the study groups

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The preoperative and postoperative Hb level in the study groups: there was nonsignificant difference between the two groups in Hb levels preoperatively and 24 h postoperatively (P > 0.05). But there was significant difference between two groups in Hb level 48 h postoperatively (P < 0.04) [Table 2]. Also, as regard the mean reduction in Hb level preoperatively and postoperatively in the study groups, there was nonsignificant difference at 24 h between the two groups, but there was significant difference at 48 h postoperatively (P < 0.04) [Table 2].
Table 2: Hemoglobin level preoperatively postoperatively in the study groups

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There was significant difference (P < 0.05) in blood transfusion between the two groups with higher in group A than in group B [Table 3].
Table 3: Blood transfusion in study groups

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There was significant difference (P < 0.05) between two groups regarding wound discharge (minimal or moderate compared with the total number of cases in each group) in study groups [Table 4]. The wound discharge was considered minimal when there were just spots of discharge staining the dressing, while considered moderate if the dressing is partly soaked.
Table 4: Dressing reinforcement and ecchymosis in study groups

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As regards dressing reinforcement in the study groups, there was significant difference (P < 0.05) between groups, with less need for dressing reinforcement in group A (treated with drain) than in group B (treated without drain), not only in the number of patients required dressing reinforcement but also in the number of changing dressings among those patients [Table 4]. Changing of dressing indicated if it is fully soaked with blood or discharge when inspected by the researcher.

Regarding ecchymosis in the study groups, there was significant difference (P < 0.05) between two groups with lower in the percentage of patients having ecchymosis in group A than in group B [Table 4]. Ecchymosis is considered minimal when skin discoloration is not dark, for distance within 5 cm from the surgical line, and considered moderate when darker or exceeds 5 cm from the surgical line.

SSI in the study groups shows nonsignificant difference (P > 0.05). In group A, two cases developed SSI at day 6 postoperatively; one of them required reoperation (debridement and wash at 10th day postoperatively), and the other case resolved by antimicrobial therapy for 2 weeks. In group B, only one case showed SSI at day 10 postoperatively and indicated antimicrobial therapy for 2 weeks. The surgical site is considered infected when there is purulent discharge with hyperemic edges of the wound. Late wound infection cannot be fully assessed because of the relatively short follow-up duration of the study [Table 5].
Table 5: Hospital stay and early surgical site infection in study groups

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Concerning hospital stay in the study groups, there was nonsignificant difference between the two groups (P > 0.05) [Table 5].


  Discussion Top


Wound hematomas are inevitable following orthopedic operations because complete hemostasis is difficult to achieve when the medullary canal has been exposed, subsequent effect of hematoma is increased tension over the wound resulting in decreased tissue perfusion, delaying healing process, and providing a rich medium for bacterial culture[1]. Thus, the use of suction drains after major operations seems to be a very logical and effective way of reducing the size of postoperative wound hematomas[5].

On other hand, some may argue that drains may provide an entry access point for bacteria through the drain itself or through its tract, persistent wound discharge with even fistula formation, and intra-articular fibrosis with subsequent poor functional outcome[7],[8].

The debate over prophylactic wound drainage transcends orthopedic surgery. Lawson Tait's say 'when in doubt, drain' was countered by Halsted (1898) who argued that 'no drainage at all is better than the ignorant employment of it'[9].

While many surgeons may continue the 'routine' practice of prophylactic wound drainage, there is increasing clinical evidence that the use of drains confer no advantages over their nonuse in clean orthopedic wounds[10].

The literature carries conflicting reports on the use of drains. A meta-analysis by Parker et al.[11]suggested that they may do harm more than good and that their only proven benefit is a reduced need for the change of dressing.

Moreover, many authors reported significantly increased need for postoperative transfusions in patients treated with drains[12],[13],[14].

Murphy et al.[15]in a prospective, randomized trial involving 40 patients concluded that there is a statistically significant difference between both groups regarding the total blood loss.

Ovadia et al.[16] found that the use of drains gave an increased need for transfusion. Combining these results gives a trend toward increased transfusion requirements if wounds are drained, but the difference was not statistically significant.

Nicolajsen et al. reported without data no difference in the requirement for transfusion between groups.

Widman et al.[17]stated that 'the total blood loss, of course, was higher in the drained group, since this included the drained blood. The group with drains needed more blood transfusions'.

Della Valle et al.[18]found that patients receiving CSD had more marked reductions in hematocrit (10.4 vs. 7.4) (P = 0.03), and a longer hospital stay (5.1 vs. 4.7 days) than those without a drain (P = 0.01).

Walmsley et al.[19]found that there was no significant difference between the groups in terms of the mean preoperative and postoperative hemoglobin levels or the length of hospital stay. However, in the drained group the percentage of patients requiring transfusion was significantly higher (33 vs. 26.4%; P = 0.042).

In this randomized controlled trial result show:

As regarding hemoglobin levels

In our series, we found that there was nonsignificant difference in the levels preoperatively and 24 h postoperatively, while in 48 h postoperative there was a significant difference of more reduction in group A (using drain), mean Hb reduction 48 h postoperatively in group A 3.01 ± 0.57 and in group B 2.57 ± 0.04, while the time of drain removal was 24 h postoperatively, it seemed that more blood loss occurred in group A than in group B at 48 h postoperatively (1 day after drain removal reflecting the drain effect), which may indirectly indicate that using CSD caused more blood loss (of about 0.44 mg/dl of Hb) in group A than in group B. This is in accordance with Biggi et al.[20], Della Valle et al.[18], and many authors [Table 6].
Table 6: Postoperative hemoglobin level and blood loss

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As regarding volume of blood transfusion

There was a significant difference, with more patients needed transfusion in the group of patients treated with CSDs (37/50; 74% in group A, 26/50; 52% in group B), and also the mean volume of transfusion was more in the same group (565 ± 15 ml in group A, 260 ± 0.00 ml in group B) This is in agreement with Ovadia et al.[16], Widman et al.[17], and most of other studies [Table 7].
Table 7: Need for blood transfusion

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As regarding early surgical site infection

In our randomized controlled trial, there was nonsignificant difference between the two study groups regarding early wound infection (two patients in group A and only one patient in group B) but considered numerically statistically nonsignificant. This is in accordance with Kim et al.[21], Ovadia et al.[16], Niskanen et al.[22], and Widman et al.[17] whereas Walmsley et al.[19] classified SSIs into superficial and deep infection gave the same results.

As regarding wound discharge, need for dressing reinforcement, and ecchymosis

There was significant difference between two groups with more incidence of discharge in nondrained patients (33/50 in group A, 36/50 in group B) with subsequent need for dressings changing (40/50 in group A, 46/50 in group B). Also more number of patients showed wound ecchymosis in the nondrained group (23/50 in group A, 30/50 in group B). This is in agreement with Kim et al.[21] and Niskanen et al.[22], but in disagreement with Dora et al.[23] [Table 8].
Table 8: Number of needed dressings

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As regarding hospital stay

There was nonsignificant difference between two groups with mean number of days (4.37 in group A) and (4.22 in group B). This is in agreement with Biggi et al.[20], Ovadia et al.[16], Parker et al.[11], and Walmsley et al.[19].

But Kleinert et al.[24] showed significant longer hospital stay in the group of patients treated with drain either with or without reinfusion.

After reviewing literatures concerned with the same topic we compared our results with the results of other studies. The following tables show comparison between the results of different items in our study and the other studies.


  Conclusion Top


If we have to give a recommendation that is based on solid clinical evidence about the use of drain in primary THA, we conclude that patients must be evaluated carefully preoperatively. If the patients' clinical manifestation show anemia (Hb level at a lower margin of normal range), we recommend that drain should not be used to decrease the risk for blood loss and subsequent requirement for transfusion, and if the general condition of the patient is just normal with high preoperative Hb level (high normal of 15 g/dl or more), the closed-suction drainage to be used for the favor of better wound condition (wound tension and discharge, need for dressing reinforcement, wound ecchymosis).

Limitations

Being a prospective, randomized, controlled study, comparing the impact of using the suction drainage system to no drainage in a specific region, using the same protocol and following the guidelines with all patients added strengths to the study. However:

  1. Postoperative laboratory assessment of blood loss (Hb level) was of short duration in the first 24 h and 48 h detecting early reduction in Hb and hematocrit only which may need further assessment on third and seventh days postoperatively to detect late reduction
  2. The number of cases enrolled in this study was relatively small, especially regarding wound infection outcome. In order to get a statistically significant difference and obtain reliable results sample size should be more
  3. Many variables influence the Hb level and drain output. By conducting the same operative technique, we tried to minimize differences of intraoperative blood loss. But, several factors that still could affect clinical outcome included different fluid therapy.
[27]

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
Waugh T, Stinchfield F. Suction drainage of orthopaedic wounds. J Bone Joint Surg Am 1961; 43-A:939–946.  Back to cited text no. 1
    
2.
Yiannakopoulos CK, Kanellopoulos AD. Innoxious removal of suction drains. Orthopedics 2004; 27:412–414.  Back to cited text no. 2
    
3.
Tucci G, Amorese V, Romanini E. Closed suction drainage after orthopaedic surgery: evidence versus practice. J Orthop Traumatol 2006; 7:29–32.  Back to cited text no. 3
    
4.
Zhou XD, Li J, Xiong Y, Jiang LF, Li WJ, Wu LD. Do we really need closed-suction drainage in total hip arthroplasty? A meta-analysis. Int Orthop 2013; 37:2109–2118.  Back to cited text no. 4
    
5.
Koyano G. Is closed suction drainage effective in early recovery of hip joint function? Comparative evaluation in one-stage bilateral total hip arthroplasty. J Arthroplasty 2015; 30:74–78.  Back to cited text no. 5
    
6.
Lee G-W, Park KS, Kim DY, Shin YR, Yoon TR. New strategy of closed suction drainage after primary total hip arthroplasty. Acta Orthop Traumatol Turc 2017; 51:223–226.  Back to cited text no. 6
    
7.
Parrini L, Baratelli M, Parrini M. Ultrasound examination of hematomas after total hip replacement. Int Orthopacdics 1988; 12:79–82.  Back to cited text no. 7
    
8.
Sørensen AI, Sørensen TS. Bacterial growth on suction drain tips. Acta Orthop Scand 1991; 62:451–454.  Back to cited text no. 8
    
9.
Levy M. Intraperitoneal drainage. Am J Surg 1984; 147:309–314.  Back to cited text no. 9
    
10.
Ikpeme IA, Ngim NE, Ilori IU, Oku E, Udosen AM. Prophylactic wound drainage in orthopaedics: a comparative evaluation of closed suction drainage versus no-drainage in a nigerian teaching hospital. Glob J Orthop Phys Thera Pract 2014; 2:016–021.  Back to cited text no. 10
    
11.
Parker MJ, Livingstone V, Clifton R, McKee A. Closed suction surgical wound drainage after orthopaedic surgery. Cochrane Database Syst Rev 2007; 18:CD001825.  Back to cited text no. 11
    
12.
Esler CNA, Blakeway C, Fiddian NJ. The use of a closed suction drain in total knee arthroplasty. A prospective randomised study. J Bone Joint Surg Br 2003; 85:215–217.  Back to cited text no. 12
    
13.
Hill RMF, Brenkel I. Drain vs. no drain in unilateral total hip arthroplasty: a randomised prospective trial. J Bone Joint Surg Br 2003; 85(Suppl 2):104.  Back to cited text no. 13
    
14.
Ritter MA, Keating EM, Faris PM. Closed wound drainage in total hip or total knee replacement. A prospective randomised study. J Bone Joint Surg Am 1994; 76:35–38.  Back to cited text no. 14
    
15.
Murphy WG, Davies MJ, Eduardo A. The haemostatic response to surgery and trauma. Br J Anaesth 1993; 70:205–213.  Back to cited text no. 15
    
16.
Ovadia D, Luger E, Menachem A, Dekel S. Efficacy of closed wound drainage after total joint arthroplasty. A prospective randomized study. J Arthroplasty 1997; 12:317–321.  Back to cited text no. 16
    
17.
Widman J, Jacobsson H, Larsson SA, Isacson J. No effect of drains on the postoperative hematoma volume in hip replacement surgery. A randomized study using scintigraphy. Acta Orthop Scand 2002; 73:625–629.  Back to cited text no. 17
    
18.
Della Valle AG, Slullitel G, Vestri R, Comba F, Buttaro M, Piccaluga F. No need for routine closed suction drainage in elective arthroplasty of the hip. A prospective randomized trial in 104 operations. Acta Orthop Scand 2004; 75:30–33.  Back to cited text no. 18
    
19.
Walmsley PJ, Kelly MB, Hill RF, Brenkel I. A prospective, randomised, controlled trial of the use o drains in total hip arthroplasty. J Bone J Surg Br 2005; 87:1397–1401.  Back to cited text no. 19
    
20.
Biggi F, D'Antimo C, Trevisani S, Di Fabio S. Efficacia dei drenaggi nella chirurgia protesica standard dell'anca e del ginocchio. GIOT 2005; 31:130–132.  Back to cited text no. 20
    
21.
Kim Y-H, Cho S-H, Kim R-S. Drainage versus nondrainage in simultaneous bilateral total hip arthroplasties. J Arthroplasty 1998; 13:156.  Back to cited text no. 21
    
22.
Niskanen RO, Korkala OL, Haapala J, Kuokkanen HO, Kaukonen JP, Salo SA. Drainage is of no use in primary uncomplicated cemented hip and knee arthroplasty for osteoarthritis. A prospective randomized study. J Arthroplasty 2000; 15:567–569.  Back to cited text no. 22
    
23.
Dora C, von Campe A, Mengiardi B, Koch P, Vienne P. Simplified wound care and earlier wound recovery without closed suction drainage in elective total hip arthroplasty. A prospective randomized trial in 100 operations. Arch Orthop Trauma Surg 2007; 127:919–923.  Back to cited text no. 23
    
24.
Kleinert K, Werner C, Mamisch-Saupe N, Kalberer F, Dora C. Closed suction drainage with or without re-transfusion of filtered shed blood does not offer advantages in primary noncemented total hip replacement using a direct anterior approach. Arch Othop Trauma Surg 2012; 132:131–136.  Back to cited text no. 24
    
25.
Johansson T, Engquist M, Pettersson LG, Lisander B. Blood loss after total hip replacement: a prospective randomized study between wound compression and drainage. J Arthroplasty 2005; 20:967–971.  Back to cited text no. 25
    
26.
Strahovnik A, Fokter SK. The effect of drainage after hip arthroplasty. In: Samo F, editor. Recent advances in hip and knee arthroplasty (ISBN: 978-953-307-841-0); 2012. Available from: http://www.intechopen.com/books/recent-advances-in-hip-and-knee-arthroplasty/the-effect-of-drainage-after-hip-arthroplasty.  Back to cited text no. 26
    
27.
Cheung EV, Sperling JW, Cofield RH. Infection associated with hematoma formation after shoulder arthroplasty. Clin Orthop Relat Res 2008; 466:1363–1367.  Back to cited text no. 27
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]


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