J Nephrol DOI 10.1007/s40620-013-0031-2
REVIEW
Laparoscopic peritoneal dialysis catheter (PDC) insertion: does it really make a difference? Atul Bagul • Umasankar Mathuram Thiyagarajan Nizam Mamode
•
Received: 19 May 2013 / Accepted: 28 July 2013 Italian Society of Nephrology 2014
Abstract Permanent peritoneal dialysis (PD) access was first described and introduced in clinical practice more than 40 years ago. It is still undergoing modification and adaptation to various insertion techniques. PD Catheter insertion is commonly performed via one of the three techniques: (a) open surgical, (b) fluoroscopic-guided placement or blind percutaneous placements using a modified Seldinger technique and (c) minimally invasive. Catheter placement is thought to be the key to a successful PD programme and the economic advantages are lost if a patient switches to HD during the 1st year due to failure of PD. The objective of this document was to conduct an evidence-based assessment of a minimally invasive approach to PD catheter insertion, with particular regard to failure rates secondary to catheter dysfunction. Case series and randomised controlled trials suggest that laparoscopic placement of peritoneal dialysis catheters is safe, and useful for insertion of PD catheters in patients who have undergone previous abdominal surgery. An overall success rate of 90% with a less than 5% associated leak rate has been quoted, although a cost benefit analysis has not been performed. However, good grade I evidence is lacking and open surgery may be quicker, though results from on-going trial are awaited with interest. Keywords Laparoscopy Peritoneal dialysis Catheter dysfunction
40 years ago [1]. It is still undergoing modification and adaptation to various insertion techniques. PD has certain advantages, as it is carried out at home, which optimises quality of life [2, 3], is useful in patients running out of haemodialysis (HD) access and is much more cost effective (HD: £35,000 UK per patient per year versus PD £17,500; http://www.organdonation.nhs.uk) [4]. Catheter placement is thought to be the key to a successful PD programme and the economic advantages are lost if a patient switches to HD during the first year due to failure of PD [5]. Peritoneal dialysis catheter (PDC) insertion is commonly performed via one of three techniques: (a) open surgical, (b) fluoroscopic-guided placement or blind percutaneous placements using a modified Seldinger technique, and (c) with a minimally invasive procedure either by standard laparoscopy or peritoneoscopic technique [1]. The key factor leading to modification of the various techniques of catheter placement is the rate of catheter dysfunction [2]. The UK Renal Association’s Peritoneal Access Guidelines: peritoneal dialysis (RA/PAG:PD) [6] recommend that each centre should have a dedicated team involved in the implantation and care of peritoneal catheters and the primary non function rate for PDC in the literature is quoted at no more than 10 % [7]. The acceptable 12-month catheter survival is considered to be greater than 80 % (RA/PAG:PD 7.1) [6, 8, 9].
Introduction Permanent peritoneal dialysis (PD) access was first described and introduced into clinical practice more than A. Bagul (&) U. M. Thiyagarajan N. Mamode St Georges Hospital, London, UK e-mail: [email protected]
Objective The aim of this study was to conduct an evidence-based assessment of a minimally invasive approach to PD catheter insertion, with particular regard to failure rates secondary to catheter dysfunction.
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Search strategy A search of the following databases was performed: Medline (Pubmed, 1966–2011), Cochrane Central Register of Controlled Trials, EMBASE (1974–2011), Database of Abstracts of Reviews of Effects (DARE), and Health technology assessment database (HTA). The search strategy was based on the following search terms: • • • • • • • • •
Laparoscopy and peritoneal dialysis [MeSH Terms] Peritoneal dialysis catheter insertions Peritoneal dialysis catheter dysfunction Surgical manoeuvres for peritoneal dialysis Laparoscopic peritoneal dialysis catheter insertion Open PDC insertions Tenckhoff PDC catheters Peritoneoscopic PDC insertions Controversy of PDC
Fig. 1 PRISMA flow diagram
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•
The Renal Association clinical guideline UK peritoneal access guidelines (PD access)
The search generated 72 articles, of which 24 were not relevant (duplicate, non-English literature, or nonsurgical techniques). Fluoroscopic techniques are becoming increasingly popular, but this review was restricted to surgically placed PDC, i.e. open and laparoscopic surgical techniques. The remaining 48 referenced documents included 6 randomised controlled studies (RCT), 9 prospective non randomised studies (PNR), 14 reviews, 2 guidelines and 17 observational/case series (CS) (Fig. 1).
The problem The various PDC insertion techniques have been discussed in great depth in a number of publications [1, 10–15]. The success of PD depends upon the presence of a functional
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and durable long term access to the peritoneal cavity, which depends upon placement technique rather than on catheter design [16]. The need for further intervention to correct catheter dysfunction not only discourages patients from continuing with PD, but also off-sets the cost benefit especially if patients have to move to haemodialysis. Catheter dysfunction includes inflow problems, drainage problems, catheter migration and pericatheter leaks; these occur in a range from 6 to 17.1 % of cases (for percutaneous needle guided techniques 10.5–11.2 % [15, 17], for open surgical placement 10.4–17.1 % [5, 18, 19] and for laparoscopic techniques 6–6.9 % [18, 20, 21]. Laparoscopic techniques could be more cost effective due to shorter hospital stay, accurate PDC placement, longer functional survival, lower leak rates and a reduced risk of complications compared with other techniques [22– 24]. They may also permit proper assessment of the peritoneal cavity and appropriate manoeuvres to deal with problems resulting from previous abdominal/re-do abdominal surgery [25]. The importance of identification and addressing the problems (such as omental entrapment, peritoneal adhesions and concurrent hernia repairs) at the time of the implantation procedure is potentially a major advantage of surgical laparoscopy over these other techniques [26].
Laparoscopic advantages and current evidence The use of laparoscopy for PDC insertion is now considered to be a well-established procedure. The current procedural terminology editorial panel of the American Medical Association implemented a new procedural code specific for laparoscopic dialysis catheter implantation in 2007, in the absence of Grade I evidence [22]. Evidence regarding the efficacy or otherwise, of laparoscopic PD catheter placement comes mainly from retrospective and prospective case series, with only four reported randomised controlled trials and a meta-analysis. These data are summarised in Tables 1 and 2.
Uncontrolled studies Findings from the analysis of uncontrolled studies are summarised in Table 1. First, we focus on the case series. Crabtree et al. [2] showed that meticulous use of laparoscopy led to a low complication profile in their series, achieving a catheter obstruction rate of 3.7 %, pericatheter leak of 2.6 %, and cumulative revision free and assisted catheter survival probabilities of 0.96 and 0.99 respectively at 5 years. Similarly Haggerty et al. [27] showed a reduced catheter flow obstruction rate of 6.5 %. The dimension of
the centre may have an impact on success of implantation as seen by data published by Crabtree et al. (n = 428, catheter survival at 96 % at 21.6 months of follow-up) [2]. Similarly a study by Maio et al. [20] (n = 100) showed a survival of 91 % at 22 months. Though, on balance, some authors suggest leaving this more expensive tool as a resort to deal with simultaneous adhesiolysis for catheter placement in a selective population of patients having had previous surgery, catheter salvage or a simultaneous abdominal procedure. Ogunc et al. [28] who routinely performed a rectus sheath tunnelling and omentopexy in addition to adhesiolysis showed no occurrence of omental entrapment or catheter blockages: this small series included a 20.5 % prevalence of previous abdominal surgery, but catheter obstruction and pericatheter leaks were reduced to zero (17 and 11 % with open surgery). Wang et al. [29] in their case series concluded that laparoscopic associated placement of a PDC permits simultaneous identification and correction of intra- abdominal adhesions for patients with recent operations which otherwise may complicate dialysis therapy, and reported an overall success rate of 90 % with a 5 % associated leak rate. Schmidt et al. [30] reported an uncensored (death and renal transplant) cumulative catheter survival of 63.8 % at 17 months with a 19.1 % mechanical complication rate (fluid leakage in 6 patients, catheter tip migration in 2, and catheter obstruction in 1 patient). Lu et al. [4], in a series of laparoscopic placements performed over 7 years involving 148 procedures, reported a 31 % rate of technical problems in re-do surgery where catheters needed either to be replaced or removed. Gajjar et al. [31] reported that laparoscopic-PD catheter insertion offered a 97.8 % immediate functional success as compared to 80 % with open placement (P = 0.014) as well as a lower incidence of PDC revision or replacement (P = 0.035). They reported a similar leak rate between both the groups (laparoscopic 11 vs. 13 % open group). In addition, other non-randomised studies showed superior outcome and based this on the various techniques available to the surgeon which may include selective omentopexy, omentectomy, adhesiolysis, resection of epiploic appendices (especially after an on-table catheter flow check), simultaneous repair of underdiagnosed abdominal hernia, rectus sheath tunnelling and laparoscopic fixation of catheters to the pelvis [32–38].
Randomised controlled trials There are four completed RCTs of laparoscopic PD catheter placements versus open surgery (Table 2). The main outcome measures included duration of surgery, hospital stay, pain scores, and analgesic requirements, as well as
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J Nephrol Table 1 Outcomes after laparoscopic versus open PDC insertion: uncontrolled studies Study
N (L/O)
Catheter flow obstruction (%)
Pericatheter leak rates (%)
Migration rates (%)
Pericatheter hernias (%)
Follow interval (month)
Catheter survival (%)
Age (years)
Sex ratio (M/F) (%)
Surgeon (S) (n)
LU [4]
148
31
0
5
7
42
53a
55
53/47
1S
2003, CS
(20–83)
Wang [29] 2005, CS
20
10
5
0
7
1
90
38.5 (29–58)
37.5/62.5
1S
Haggerty [27]
31
6.5
0
0
3.3
14
93
57
50/50
3S
64/36
–
2007, CS Schmidt [30]
(36–74) a
47
2.1
12.8
2
6.4
17
63.8
Maio [20]
100
6
5
6
0
22.35 ± 16.5
91
46
42/58
1 Team
2008, CS Crabtree [2]
428
3.7
2.6
0
0
21.6
96
(21–81) 54.8 ± 14.1
50.2/49.8
1 centre
Daschner [44]
42
8 (L)
8 (L)
0
0
1
88
6.9 (2–19)
–
1 centre
2002, PPNR
(25/ 23)
8.6 (O)
21.7 (O)
Ogunc [28]
79
0 (L)
0 (L)
34/66
1S
2005, PNRHC
(44/ 35)
17 (O)
11 (O)
Mattioli [45]
30
0 (L)
6.1 (L)
0 (L)
0
14.2 (1.4–21)
53/47
1 Team
2007, PPNR
(15/ 15)
20 (O)
17.5 (O)
13 (O)
0
13.4 (1.1–17)
50/50
Gajjar [31]
75
2.5 (L)
11 (L)
0
5 (L)
97.8b
58 ± 17
52/48
3 centre
2007, PNR
(45/ 30)
14.28 (O)
13.4 (O)
0
0
80b
62 ± 16.5
68/32
Selective S
2007, CS
52 (20–74)
2009, CS
3.2 (2–19) 0
0
17.4
100
51.6 (18–67)
14
6
100
PDC peritoneal dialysis catheter, CS case series, PNR prospective non randomised, PNRHC prospective non randomised compared to historic control, PPNR paediatric prospective non randomised, RCT randomised controlled trial, L laparoscopic, L-P peritoneoscopic, O open surgery a
Uncensored catheter survival
b
p B 0.05
complications (early/late) and catheter survival. The single blinded prospective RCT by Wright et al. [39] showed that there was no difference in outcomes other than an increased procedure time (7 min) for laparoscopic implants and supported conventional open surgery. Unfortunately this study did not include a statistical power calculation; 50 patients were sequentially randomised to either conventional or laparoscopic groups (5 excluded, n = 45; 24/21 respectively) on the hypothesis that the smaller incision of the laparoscopic method may cause less discomfort and/or a lower incidence of early complications. The authors point out the limitation of their study with the possibility of a type II statistical error (with respect to complication rates)
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and suggest that a study with several hundred patients in each arm would be required, as the complication rates were too low. Similarly Jwo et al. [16] showed that laparoscopic assisted percutaneous puncture was not superior to open surgery. They further concluded that open surgery had a shorter operative time and was more cost-effective. This study was under-powered and possibly flawed as the cost analysis did not take into consideration further surgery to deal with the higher early complication rate of catheter migration after open surgery with respect to laparoscopic procedures (15 vs. 2.7 % respectively). This study randomly allocated the 77 patients (40 open and 37
J Nephrol Table 2 Outcomes after laparoscopic versus open PDC insertion: controlled studies Study
N (L/O)
Catheter flow obstruction (%)
Pericatheter leak rates (%)
Migration rates (%)
Pericatheter hernias (%)
Follow interval (month)
Catheter survival (%)
Age (years)
Sex ratio (M/F) (%)
Surgeon (S) (n)
Gadallah [11]
148
7.9 (L-P)
1.3 (L-P)
0
1.3 (L-P)
36
45 ± 1.8
47/53
3S
1999, RCT (P) Wright [39] 1999, RCT
(78/72) 50c (21/24)
11.1 (O) 0 (L) 0 (O)
11.1 (O)b 8 (L) 0 (O)
0 0 0
1.4 (O) 0 0
18.5
51.3 (L-P)a,b 36 (O) 57 (L)a 54 (O)
47.2 ± 2.4 46.4 ± 14.8 49.3 ± 20.2
Tsimoyiannis [40] 2000, RCT Jwo [16] 2010, RCT
50
0 (L)
0 (L)
0 (L)
0
21 ± 11
96 (L)a,b
58 (24–74)
40/60 62.5/37.5 66.6/ 33.33 80/20
(25/25) 77 (37/40)
12.5 (O) 2.7 (L) 0 (O)
32 (O) 15 (L) 18.9 (O)
20 (O) 2.7 (L) 15 (O)
0 0 0
31
76 (O) 67.5 (L)a 77 (O)
62 (48–72) 54.4 ± 16.5 56.6 ± 13.4
72/28 45/55 32.4/67.5
1S
1 centre
1S
PDC peritoneal dialysis catheter, CS case series, PNR prospective non randomised, PNRHC prospective non randomised compared to historic control, PPNR paediatric prospective non randomised, RCT randomised controlled trial, L laparoscopic, L-P peritoneoscopic, O open surgery a Uncensored catheter survival b p B 0.05 c 5 exclusions
laparoscopic) by an independent process. A number of outcomes ranging from operative data, complication rates and catheter survival were recorded, without a specific power calculation and thus raising the issues of a type II error. The rate and cause of overall mortality or catheter dropout did not statistically differ and catheter longevity was equivalent in both groups. This study only included patients undergoing primary insertion of PD catheters, which is important as laparoscopic placement may allow better outcomes. Tsimoyiannis et al. [40] concluded that laparoscopic placement of a PD catheter with pelvic fixation leads to better function than when placed with an open procedure. The procedure also allows immediate use of the PD catheter without fluid leakage and permits simultaneous performance of other laparoscopic procedures. This randomised trial recruited 50 patients, 25 in each arm, and the results demonstrated a quicker open procedure (22 vs. 29 min; P = 0.001), although higher leak rates (8 vs. 0; P \ 0.005; 32 %) and catheter tip migrations (5 vs. 0; P \ 0.005; 20 %) for the open group. This study, however, also lacks power; primary and secondary outcomes were not defined and it did not consider how leaks and catheter tip migrations were addressed. Only three simultaneous procedures (two cholecystectomies and one hernia) were carried out. Gadallah et al. [11] described an RCT comparing percutaneous implantation via the peritoneoscopic technique under local anaesthesia versus open surgical technique. In their cohort of 148 patients they clearly showed a better survival with peritoneoscopically placed catheters (77.5 % at 12 months, 63 % at 24 months, and 51.3 % at 36 months) than those placed surgically (62.5 % at 12 months, 41.5 % at
24 months, and 36 % at 36 months) (P = 0.02, 0.01, and 0.04, respectively). In addition, early peritonitis episodes (within 2 weeks of catheter placement) occurred in 9 of 72 patients (12.5 %) in the surgical group versus 2 of 76 patients (2.6 %) in the peritoneoscopy group (P = 0.02). The authors related this higher rate of infection to most probably a higher exit site leak in the surgical group (11.1 %) as compared with the peritoneoscopy group (1.3 %) (P = 0.002). Unfortunately this trial was related to first time catheter placements (the technique will not permit additional surgical techniques as described by Frost et al. [41]) and lacked a cost benefit analysis. Hagen et al. [42] have reported the study design of the ‘LOCI’ trial which is a multicentre, randomised, single blinded laparoscopic versus open surgery trial powered to address malfunction at 6 weeks, and is currently recruiting. This study should thus generate grade I evidence and allow a definite answer regarding the efficacy of laparoscopic PD placement.
Meta-analysis Xie et al. [43] in a systemic review and meta-analysis showed that laparoscopic catheter placement had no superiority to open surgery in relation to: hospital stay and early complications/infections (odds ratio, OR = 0.92; 95 % confidence interval, CI 0.61–1.39; P = 0.70), dialysate leak (OR = 0.46; 95 % CI 0.11–1.83: P = 0.27), and catheter migration (OR = 0.61; 95 % CI 0.33–1.17; P = 0.14). They did not perform a cost benefit analysis or catheter survival analysis and pointed out that heterogeneity due to operations by a
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number of different surgeons, study designs, PDC types and operation techniques may have impacted on the outcomes. The biggest drawback of this meta-analysis is that it lacks long term outcomes. The analysis highlights possible advantages, e.g. omentum can be fixed and trimmed, and postoperative complications may be reduced under laparoscopy. These advantages possibly induce clinicians to use the laparoscopic approach. On the other hand, this approach has potential problems including advanced technique, high cost, and relatively high anaesthesia risk; these important aspects unfortunately lack an evidence-based analysis. The authors make a very firm conclusion with lack of long term data and go on to say that, weighing up the pros and cons, the surgical approach to choose depends on the specific conditions and the clinician.
Paediatric laparoscopic PDC There are specific issues related to PDC insertion in children; open surgery may be more difficult through a small incision in very small children, making catheter placement inaccurate, and in the relatively common setting of acute renal failure urgent placement is required with immediate use, so that minimising pericatheter leaks is vital (Table 1). Daschner et al. [44] reported that laparoscopic PDC is feasible in children of all age groups, with equivalent functional results compared to conventional PDC. The prospective nonrandomized controlled study included 42 patients (between 1998 and 2001), with 25 laparoscopic (LAP) and 23 conventional interventions. The authors reported a catheter dysfunction rate of 8 % (LAP) vs. 8.6 % (open) and leak rate of 2/25 (8 %) vs. 5/23 (21.7 %) respectively. The additional advantage highlighted was an opportunity to identify and eliminate anatomical risk factors such as intra-abdominal adhesions or preformed inguinal hernias in male infants. Similarly, Mattioli et al. in a small series of 15 cases per group showed no added benefit but in addition concluded that laparoscopy allowed for careful assessment of the abdominal cavity, recognition and treatment of intra-abdominal diseases, and precise placement of PDCs. They showed a smaller leak rate of 1 (6.1 %) for laparoscopy compared to 3 (17.5 %) for the open group. Mechanical obstruction remained a common cause of early catheter malfunction (both open and LAP study groups) although laparoscopy allowed for the rescue of a blocked catheter [45].
Optimal time to commence PD: laparoscopy and immediate use The UK Renal Association guidelines and European best practice guidelines for peritoneal dialysis suggest that an
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approximately 2-week delay before using the catheter (RA/ PAG:PD2.1) [6, 46] results in less likelihood of exit-site infection and dialysate leak [28, 36] based on evidence from retrospective studies. Reported leak rates are lower for all documented laparoscopic series, even when catheters are used immediately on the day of insertion, and it may be that early use is feasible with laparoscopic insertion [2, 18, 20, 21, 29, 30]. Currently a randomised control study (Timely PD study) has been set up to address this issue [47].
Surgeon, nephrologist or radiologist? Crabtree published an interesting article addressing this issue [48]. He raised a valid argument about surgical workforce, current infrastructure and well described procedures supported by his centre’s exceptional outcomes. On balance he raised the point about suboptimal performances by surgeons which has led to a surge in nephrologists as PD providers. This is supported by the nephrologist argument of expedient catheter placement, lower institutional cost, and local anaesthetic day case procedures with matched outcomes. The imperfect methodology and restrictive indications probably should favour the surgeon, i.e. a ‘dedicated surgical team’. In our opinion, the outcomes for all three service providers are acceptable with the following recommended learning curve. As literature surveys of contemporary experiences suggest, 50 or more catheter insertions with an average follow-up of 12 months reflect better outcomes.
Perspectives for future studies Catheter dysfunction secondary to catheter migration is not the only major cause for failure of PD. Catheter related infections and dialysate leakages remain persistent complications which arise not only from initial implantations, but also from breaks in aseptic techniques during handling of patients, from long term-indwelling catheters and from changes in the intra-peritoneal environment after catheter implantation. The use of prophylactic antibodies is recommended and this reduces procedure related peritonitis. But late onset peritonitis remains a constant problem caused by possible catheter handling or enteric translocation. Further investigation into this issue, with the aim of developing effective methods for resolution or prevention is thus warranted. Studies aimed at gaining insight into the underlying mechanism of encapsulating peritoneal sclerosis (EPS) and at increasing the length of PD survival in the case of failure to achieve adequate clearance are further warranted.
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Conclusion Case series and RCTs suggest that laparoscopic placement of peritoneal dialysis catheters is safe, with an equivalent functional outcome to catheters placed at open surgery, and may be useful for patients who have undergone previous abdominal surgery. A clear comparison of cost benefit with open surgery has not been performed. Laparoscopic placement allows additional procedures like selective omentopexy, omentectomy, adhesiolysis, a visualised ontable catheter flow check and simultaneous repair of underdiagnosed abdominal hernia which may improve the outcome. However, good grade I evidence is lacking and open surgery may be quicker, though results from on-going trials are awaited with interest. Conflict of interest
None to declare.
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REVIEW
Laparoscopic peritoneal dialysis catheter (PDC) insertion: does it really make a difference? Atul Bagul • Umasankar Mathuram Thiyagarajan Nizam Mamode
•
Received: 19 May 2013 / Accepted: 28 July 2013 Italian Society of Nephrology 2014
Abstract Permanent peritoneal dialysis (PD) access was first described and introduced in clinical practice more than 40 years ago. It is still undergoing modification and adaptation to various insertion techniques. PD Catheter insertion is commonly performed via one of the three techniques: (a) open surgical, (b) fluoroscopic-guided placement or blind percutaneous placements using a modified Seldinger technique and (c) minimally invasive. Catheter placement is thought to be the key to a successful PD programme and the economic advantages are lost if a patient switches to HD during the 1st year due to failure of PD. The objective of this document was to conduct an evidence-based assessment of a minimally invasive approach to PD catheter insertion, with particular regard to failure rates secondary to catheter dysfunction. Case series and randomised controlled trials suggest that laparoscopic placement of peritoneal dialysis catheters is safe, and useful for insertion of PD catheters in patients who have undergone previous abdominal surgery. An overall success rate of 90% with a less than 5% associated leak rate has been quoted, although a cost benefit analysis has not been performed. However, good grade I evidence is lacking and open surgery may be quicker, though results from on-going trial are awaited with interest. Keywords Laparoscopy Peritoneal dialysis Catheter dysfunction
40 years ago [1]. It is still undergoing modification and adaptation to various insertion techniques. PD has certain advantages, as it is carried out at home, which optimises quality of life [2, 3], is useful in patients running out of haemodialysis (HD) access and is much more cost effective (HD: £35,000 UK per patient per year versus PD £17,500; http://www.organdonation.nhs.uk) [4]. Catheter placement is thought to be the key to a successful PD programme and the economic advantages are lost if a patient switches to HD during the first year due to failure of PD [5]. Peritoneal dialysis catheter (PDC) insertion is commonly performed via one of three techniques: (a) open surgical, (b) fluoroscopic-guided placement or blind percutaneous placements using a modified Seldinger technique, and (c) with a minimally invasive procedure either by standard laparoscopy or peritoneoscopic technique [1]. The key factor leading to modification of the various techniques of catheter placement is the rate of catheter dysfunction [2]. The UK Renal Association’s Peritoneal Access Guidelines: peritoneal dialysis (RA/PAG:PD) [6] recommend that each centre should have a dedicated team involved in the implantation and care of peritoneal catheters and the primary non function rate for PDC in the literature is quoted at no more than 10 % [7]. The acceptable 12-month catheter survival is considered to be greater than 80 % (RA/PAG:PD 7.1) [6, 8, 9].
Introduction Permanent peritoneal dialysis (PD) access was first described and introduced into clinical practice more than A. Bagul (&) U. M. Thiyagarajan N. Mamode St Georges Hospital, London, UK e-mail: [email protected]
Objective The aim of this study was to conduct an evidence-based assessment of a minimally invasive approach to PD catheter insertion, with particular regard to failure rates secondary to catheter dysfunction.
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Search strategy A search of the following databases was performed: Medline (Pubmed, 1966–2011), Cochrane Central Register of Controlled Trials, EMBASE (1974–2011), Database of Abstracts of Reviews of Effects (DARE), and Health technology assessment database (HTA). The search strategy was based on the following search terms: • • • • • • • • •
Laparoscopy and peritoneal dialysis [MeSH Terms] Peritoneal dialysis catheter insertions Peritoneal dialysis catheter dysfunction Surgical manoeuvres for peritoneal dialysis Laparoscopic peritoneal dialysis catheter insertion Open PDC insertions Tenckhoff PDC catheters Peritoneoscopic PDC insertions Controversy of PDC
Fig. 1 PRISMA flow diagram
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The Renal Association clinical guideline UK peritoneal access guidelines (PD access)
The search generated 72 articles, of which 24 were not relevant (duplicate, non-English literature, or nonsurgical techniques). Fluoroscopic techniques are becoming increasingly popular, but this review was restricted to surgically placed PDC, i.e. open and laparoscopic surgical techniques. The remaining 48 referenced documents included 6 randomised controlled studies (RCT), 9 prospective non randomised studies (PNR), 14 reviews, 2 guidelines and 17 observational/case series (CS) (Fig. 1).
The problem The various PDC insertion techniques have been discussed in great depth in a number of publications [1, 10–15]. The success of PD depends upon the presence of a functional
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and durable long term access to the peritoneal cavity, which depends upon placement technique rather than on catheter design [16]. The need for further intervention to correct catheter dysfunction not only discourages patients from continuing with PD, but also off-sets the cost benefit especially if patients have to move to haemodialysis. Catheter dysfunction includes inflow problems, drainage problems, catheter migration and pericatheter leaks; these occur in a range from 6 to 17.1 % of cases (for percutaneous needle guided techniques 10.5–11.2 % [15, 17], for open surgical placement 10.4–17.1 % [5, 18, 19] and for laparoscopic techniques 6–6.9 % [18, 20, 21]. Laparoscopic techniques could be more cost effective due to shorter hospital stay, accurate PDC placement, longer functional survival, lower leak rates and a reduced risk of complications compared with other techniques [22– 24]. They may also permit proper assessment of the peritoneal cavity and appropriate manoeuvres to deal with problems resulting from previous abdominal/re-do abdominal surgery [25]. The importance of identification and addressing the problems (such as omental entrapment, peritoneal adhesions and concurrent hernia repairs) at the time of the implantation procedure is potentially a major advantage of surgical laparoscopy over these other techniques [26].
Laparoscopic advantages and current evidence The use of laparoscopy for PDC insertion is now considered to be a well-established procedure. The current procedural terminology editorial panel of the American Medical Association implemented a new procedural code specific for laparoscopic dialysis catheter implantation in 2007, in the absence of Grade I evidence [22]. Evidence regarding the efficacy or otherwise, of laparoscopic PD catheter placement comes mainly from retrospective and prospective case series, with only four reported randomised controlled trials and a meta-analysis. These data are summarised in Tables 1 and 2.
Uncontrolled studies Findings from the analysis of uncontrolled studies are summarised in Table 1. First, we focus on the case series. Crabtree et al. [2] showed that meticulous use of laparoscopy led to a low complication profile in their series, achieving a catheter obstruction rate of 3.7 %, pericatheter leak of 2.6 %, and cumulative revision free and assisted catheter survival probabilities of 0.96 and 0.99 respectively at 5 years. Similarly Haggerty et al. [27] showed a reduced catheter flow obstruction rate of 6.5 %. The dimension of
the centre may have an impact on success of implantation as seen by data published by Crabtree et al. (n = 428, catheter survival at 96 % at 21.6 months of follow-up) [2]. Similarly a study by Maio et al. [20] (n = 100) showed a survival of 91 % at 22 months. Though, on balance, some authors suggest leaving this more expensive tool as a resort to deal with simultaneous adhesiolysis for catheter placement in a selective population of patients having had previous surgery, catheter salvage or a simultaneous abdominal procedure. Ogunc et al. [28] who routinely performed a rectus sheath tunnelling and omentopexy in addition to adhesiolysis showed no occurrence of omental entrapment or catheter blockages: this small series included a 20.5 % prevalence of previous abdominal surgery, but catheter obstruction and pericatheter leaks were reduced to zero (17 and 11 % with open surgery). Wang et al. [29] in their case series concluded that laparoscopic associated placement of a PDC permits simultaneous identification and correction of intra- abdominal adhesions for patients with recent operations which otherwise may complicate dialysis therapy, and reported an overall success rate of 90 % with a 5 % associated leak rate. Schmidt et al. [30] reported an uncensored (death and renal transplant) cumulative catheter survival of 63.8 % at 17 months with a 19.1 % mechanical complication rate (fluid leakage in 6 patients, catheter tip migration in 2, and catheter obstruction in 1 patient). Lu et al. [4], in a series of laparoscopic placements performed over 7 years involving 148 procedures, reported a 31 % rate of technical problems in re-do surgery where catheters needed either to be replaced or removed. Gajjar et al. [31] reported that laparoscopic-PD catheter insertion offered a 97.8 % immediate functional success as compared to 80 % with open placement (P = 0.014) as well as a lower incidence of PDC revision or replacement (P = 0.035). They reported a similar leak rate between both the groups (laparoscopic 11 vs. 13 % open group). In addition, other non-randomised studies showed superior outcome and based this on the various techniques available to the surgeon which may include selective omentopexy, omentectomy, adhesiolysis, resection of epiploic appendices (especially after an on-table catheter flow check), simultaneous repair of underdiagnosed abdominal hernia, rectus sheath tunnelling and laparoscopic fixation of catheters to the pelvis [32–38].
Randomised controlled trials There are four completed RCTs of laparoscopic PD catheter placements versus open surgery (Table 2). The main outcome measures included duration of surgery, hospital stay, pain scores, and analgesic requirements, as well as
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J Nephrol Table 1 Outcomes after laparoscopic versus open PDC insertion: uncontrolled studies Study
N (L/O)
Catheter flow obstruction (%)
Pericatheter leak rates (%)
Migration rates (%)
Pericatheter hernias (%)
Follow interval (month)
Catheter survival (%)
Age (years)
Sex ratio (M/F) (%)
Surgeon (S) (n)
LU [4]
148
31
0
5
7
42
53a
55
53/47
1S
2003, CS
(20–83)
Wang [29] 2005, CS
20
10
5
0
7
1
90
38.5 (29–58)
37.5/62.5
1S
Haggerty [27]
31
6.5
0
0
3.3
14
93
57
50/50
3S
64/36
–
2007, CS Schmidt [30]
(36–74) a
47
2.1
12.8
2
6.4
17
63.8
Maio [20]
100
6
5
6
0
22.35 ± 16.5
91
46
42/58
1 Team
2008, CS Crabtree [2]
428
3.7
2.6
0
0
21.6
96
(21–81) 54.8 ± 14.1
50.2/49.8
1 centre
Daschner [44]
42
8 (L)
8 (L)
0
0
1
88
6.9 (2–19)
–
1 centre
2002, PPNR
(25/ 23)
8.6 (O)
21.7 (O)
Ogunc [28]
79
0 (L)
0 (L)
34/66
1S
2005, PNRHC
(44/ 35)
17 (O)
11 (O)
Mattioli [45]
30
0 (L)
6.1 (L)
0 (L)
0
14.2 (1.4–21)
53/47
1 Team
2007, PPNR
(15/ 15)
20 (O)
17.5 (O)
13 (O)
0
13.4 (1.1–17)
50/50
Gajjar [31]
75
2.5 (L)
11 (L)
0
5 (L)
97.8b
58 ± 17
52/48
3 centre
2007, PNR
(45/ 30)
14.28 (O)
13.4 (O)
0
0
80b
62 ± 16.5
68/32
Selective S
2007, CS
52 (20–74)
2009, CS
3.2 (2–19) 0
0
17.4
100
51.6 (18–67)
14
6
100
PDC peritoneal dialysis catheter, CS case series, PNR prospective non randomised, PNRHC prospective non randomised compared to historic control, PPNR paediatric prospective non randomised, RCT randomised controlled trial, L laparoscopic, L-P peritoneoscopic, O open surgery a
Uncensored catheter survival
b
p B 0.05
complications (early/late) and catheter survival. The single blinded prospective RCT by Wright et al. [39] showed that there was no difference in outcomes other than an increased procedure time (7 min) for laparoscopic implants and supported conventional open surgery. Unfortunately this study did not include a statistical power calculation; 50 patients were sequentially randomised to either conventional or laparoscopic groups (5 excluded, n = 45; 24/21 respectively) on the hypothesis that the smaller incision of the laparoscopic method may cause less discomfort and/or a lower incidence of early complications. The authors point out the limitation of their study with the possibility of a type II statistical error (with respect to complication rates)
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and suggest that a study with several hundred patients in each arm would be required, as the complication rates were too low. Similarly Jwo et al. [16] showed that laparoscopic assisted percutaneous puncture was not superior to open surgery. They further concluded that open surgery had a shorter operative time and was more cost-effective. This study was under-powered and possibly flawed as the cost analysis did not take into consideration further surgery to deal with the higher early complication rate of catheter migration after open surgery with respect to laparoscopic procedures (15 vs. 2.7 % respectively). This study randomly allocated the 77 patients (40 open and 37
J Nephrol Table 2 Outcomes after laparoscopic versus open PDC insertion: controlled studies Study
N (L/O)
Catheter flow obstruction (%)
Pericatheter leak rates (%)
Migration rates (%)
Pericatheter hernias (%)
Follow interval (month)
Catheter survival (%)
Age (years)
Sex ratio (M/F) (%)
Surgeon (S) (n)
Gadallah [11]
148
7.9 (L-P)
1.3 (L-P)
0
1.3 (L-P)
36
45 ± 1.8
47/53
3S
1999, RCT (P) Wright [39] 1999, RCT
(78/72) 50c (21/24)
11.1 (O) 0 (L) 0 (O)
11.1 (O)b 8 (L) 0 (O)
0 0 0
1.4 (O) 0 0
18.5
51.3 (L-P)a,b 36 (O) 57 (L)a 54 (O)
47.2 ± 2.4 46.4 ± 14.8 49.3 ± 20.2
Tsimoyiannis [40] 2000, RCT Jwo [16] 2010, RCT
50
0 (L)
0 (L)
0 (L)
0
21 ± 11
96 (L)a,b
58 (24–74)
40/60 62.5/37.5 66.6/ 33.33 80/20
(25/25) 77 (37/40)
12.5 (O) 2.7 (L) 0 (O)
32 (O) 15 (L) 18.9 (O)
20 (O) 2.7 (L) 15 (O)
0 0 0
31
76 (O) 67.5 (L)a 77 (O)
62 (48–72) 54.4 ± 16.5 56.6 ± 13.4
72/28 45/55 32.4/67.5
1S
1 centre
1S
PDC peritoneal dialysis catheter, CS case series, PNR prospective non randomised, PNRHC prospective non randomised compared to historic control, PPNR paediatric prospective non randomised, RCT randomised controlled trial, L laparoscopic, L-P peritoneoscopic, O open surgery a Uncensored catheter survival b p B 0.05 c 5 exclusions
laparoscopic) by an independent process. A number of outcomes ranging from operative data, complication rates and catheter survival were recorded, without a specific power calculation and thus raising the issues of a type II error. The rate and cause of overall mortality or catheter dropout did not statistically differ and catheter longevity was equivalent in both groups. This study only included patients undergoing primary insertion of PD catheters, which is important as laparoscopic placement may allow better outcomes. Tsimoyiannis et al. [40] concluded that laparoscopic placement of a PD catheter with pelvic fixation leads to better function than when placed with an open procedure. The procedure also allows immediate use of the PD catheter without fluid leakage and permits simultaneous performance of other laparoscopic procedures. This randomised trial recruited 50 patients, 25 in each arm, and the results demonstrated a quicker open procedure (22 vs. 29 min; P = 0.001), although higher leak rates (8 vs. 0; P \ 0.005; 32 %) and catheter tip migrations (5 vs. 0; P \ 0.005; 20 %) for the open group. This study, however, also lacks power; primary and secondary outcomes were not defined and it did not consider how leaks and catheter tip migrations were addressed. Only three simultaneous procedures (two cholecystectomies and one hernia) were carried out. Gadallah et al. [11] described an RCT comparing percutaneous implantation via the peritoneoscopic technique under local anaesthesia versus open surgical technique. In their cohort of 148 patients they clearly showed a better survival with peritoneoscopically placed catheters (77.5 % at 12 months, 63 % at 24 months, and 51.3 % at 36 months) than those placed surgically (62.5 % at 12 months, 41.5 % at
24 months, and 36 % at 36 months) (P = 0.02, 0.01, and 0.04, respectively). In addition, early peritonitis episodes (within 2 weeks of catheter placement) occurred in 9 of 72 patients (12.5 %) in the surgical group versus 2 of 76 patients (2.6 %) in the peritoneoscopy group (P = 0.02). The authors related this higher rate of infection to most probably a higher exit site leak in the surgical group (11.1 %) as compared with the peritoneoscopy group (1.3 %) (P = 0.002). Unfortunately this trial was related to first time catheter placements (the technique will not permit additional surgical techniques as described by Frost et al. [41]) and lacked a cost benefit analysis. Hagen et al. [42] have reported the study design of the ‘LOCI’ trial which is a multicentre, randomised, single blinded laparoscopic versus open surgery trial powered to address malfunction at 6 weeks, and is currently recruiting. This study should thus generate grade I evidence and allow a definite answer regarding the efficacy of laparoscopic PD placement.
Meta-analysis Xie et al. [43] in a systemic review and meta-analysis showed that laparoscopic catheter placement had no superiority to open surgery in relation to: hospital stay and early complications/infections (odds ratio, OR = 0.92; 95 % confidence interval, CI 0.61–1.39; P = 0.70), dialysate leak (OR = 0.46; 95 % CI 0.11–1.83: P = 0.27), and catheter migration (OR = 0.61; 95 % CI 0.33–1.17; P = 0.14). They did not perform a cost benefit analysis or catheter survival analysis and pointed out that heterogeneity due to operations by a
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number of different surgeons, study designs, PDC types and operation techniques may have impacted on the outcomes. The biggest drawback of this meta-analysis is that it lacks long term outcomes. The analysis highlights possible advantages, e.g. omentum can be fixed and trimmed, and postoperative complications may be reduced under laparoscopy. These advantages possibly induce clinicians to use the laparoscopic approach. On the other hand, this approach has potential problems including advanced technique, high cost, and relatively high anaesthesia risk; these important aspects unfortunately lack an evidence-based analysis. The authors make a very firm conclusion with lack of long term data and go on to say that, weighing up the pros and cons, the surgical approach to choose depends on the specific conditions and the clinician.
Paediatric laparoscopic PDC There are specific issues related to PDC insertion in children; open surgery may be more difficult through a small incision in very small children, making catheter placement inaccurate, and in the relatively common setting of acute renal failure urgent placement is required with immediate use, so that minimising pericatheter leaks is vital (Table 1). Daschner et al. [44] reported that laparoscopic PDC is feasible in children of all age groups, with equivalent functional results compared to conventional PDC. The prospective nonrandomized controlled study included 42 patients (between 1998 and 2001), with 25 laparoscopic (LAP) and 23 conventional interventions. The authors reported a catheter dysfunction rate of 8 % (LAP) vs. 8.6 % (open) and leak rate of 2/25 (8 %) vs. 5/23 (21.7 %) respectively. The additional advantage highlighted was an opportunity to identify and eliminate anatomical risk factors such as intra-abdominal adhesions or preformed inguinal hernias in male infants. Similarly, Mattioli et al. in a small series of 15 cases per group showed no added benefit but in addition concluded that laparoscopy allowed for careful assessment of the abdominal cavity, recognition and treatment of intra-abdominal diseases, and precise placement of PDCs. They showed a smaller leak rate of 1 (6.1 %) for laparoscopy compared to 3 (17.5 %) for the open group. Mechanical obstruction remained a common cause of early catheter malfunction (both open and LAP study groups) although laparoscopy allowed for the rescue of a blocked catheter [45].
Optimal time to commence PD: laparoscopy and immediate use The UK Renal Association guidelines and European best practice guidelines for peritoneal dialysis suggest that an
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approximately 2-week delay before using the catheter (RA/ PAG:PD2.1) [6, 46] results in less likelihood of exit-site infection and dialysate leak [28, 36] based on evidence from retrospective studies. Reported leak rates are lower for all documented laparoscopic series, even when catheters are used immediately on the day of insertion, and it may be that early use is feasible with laparoscopic insertion [2, 18, 20, 21, 29, 30]. Currently a randomised control study (Timely PD study) has been set up to address this issue [47].
Surgeon, nephrologist or radiologist? Crabtree published an interesting article addressing this issue [48]. He raised a valid argument about surgical workforce, current infrastructure and well described procedures supported by his centre’s exceptional outcomes. On balance he raised the point about suboptimal performances by surgeons which has led to a surge in nephrologists as PD providers. This is supported by the nephrologist argument of expedient catheter placement, lower institutional cost, and local anaesthetic day case procedures with matched outcomes. The imperfect methodology and restrictive indications probably should favour the surgeon, i.e. a ‘dedicated surgical team’. In our opinion, the outcomes for all three service providers are acceptable with the following recommended learning curve. As literature surveys of contemporary experiences suggest, 50 or more catheter insertions with an average follow-up of 12 months reflect better outcomes.
Perspectives for future studies Catheter dysfunction secondary to catheter migration is not the only major cause for failure of PD. Catheter related infections and dialysate leakages remain persistent complications which arise not only from initial implantations, but also from breaks in aseptic techniques during handling of patients, from long term-indwelling catheters and from changes in the intra-peritoneal environment after catheter implantation. The use of prophylactic antibodies is recommended and this reduces procedure related peritonitis. But late onset peritonitis remains a constant problem caused by possible catheter handling or enteric translocation. Further investigation into this issue, with the aim of developing effective methods for resolution or prevention is thus warranted. Studies aimed at gaining insight into the underlying mechanism of encapsulating peritoneal sclerosis (EPS) and at increasing the length of PD survival in the case of failure to achieve adequate clearance are further warranted.
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Conclusion Case series and RCTs suggest that laparoscopic placement of peritoneal dialysis catheters is safe, with an equivalent functional outcome to catheters placed at open surgery, and may be useful for patients who have undergone previous abdominal surgery. A clear comparison of cost benefit with open surgery has not been performed. Laparoscopic placement allows additional procedures like selective omentopexy, omentectomy, adhesiolysis, a visualised ontable catheter flow check and simultaneous repair of underdiagnosed abdominal hernia which may improve the outcome. However, good grade I evidence is lacking and open surgery may be quicker, though results from on-going trials are awaited with interest. Conflict of interest
None to declare.
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