International Journal of Surgery 16 (2015) 94e98
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Original research
Early post-operative removal of urethral catheter in patients undergoing colorectal surgery with epidural analgesia e A prospective pilot clinical study David Coyle*, 1, Kenneth M. Joyce, Joseph T. Garvin, Mark Regan, Oliver J. McAnena, Peter M. Neary, Myles R. Joyce Department of Surgery, University Hospital Galway, Newcastle, Galway, Ireland
h i g h l i g h t s We examine the timing of UC removal in colorectal surgery with epidural analgesia. This randomised clinical trial compares early removal with standard timing. The risk of urinary retention is similar in both study arms. Urinary retention only occurred in males undergoing rectal resection. This pilot clinical trial shows early UC removal is safe in females and some males.
a r t i c l e i n f o
a b s t r a c t
Article history: Received 29 October 2014 Accepted 3 March 2015 Available online 10 March 2015
Background: Urethral catheter (UC) removal is often delayed following colorectal resection due to the perceived increased risk of post-operative urinary retention (POUR) in patients with post-operative epidural analgesia (POEA). We aimed to determine if UC removal at 48 h, irrespective of ongoing POEA use, altered the risk of POUR and other morbidities associated with urethral catheterisation and immobility. Methods: We performed a prospective randomised controlled pilot clinical study. Eligible patients were randomised to an experimental arm, SG1 (UC removal 48 h post-operatively), or a control arm, SG2 (UC removed following cessation of POEA). Rates of POUR, urinary tract infection (UTI), pulmonary complications and surgical site infection (SSI) were recorded. Forty-four patients were recruited (SG1: n ¼ 22; SG2: n ¼ 22). Results: No females developed POUR, while it occurred in three males (20%) in SG1 and 2 males (22.2%) in SG2. All patients who developed POUR had undergone rectal resection. Males in SG1 were not at significantly increased risk of POUR compared to those in SG2 (R.R 0.875, p ¼ 1). No patient developed UTI post-operatively. The rate of pulmonary complications (SG1: n ¼ 2; SG2: n ¼ 3, p ¼ 0.229) and SSI (SG1: n ¼ 5; SG2: n ¼ 2, p ¼ 0.146) were similar between both study arms. Discussion: Males undergoing rectal surgery appear to be at increased risk of developing POUR in the presence of epidural analgesia, independent of the timing of UC removal. Conclusions: All female patients undergoing colorectal resection and male patients undergoing colonic resection may have their urethral catheter removed at 48 h irrespective of use of POEA. Clinical trials registration number: NCT01508767 (http://www.clinicaltrials.gov). © 2015 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
Keywords: Post-operative urinary retention Colorectal Urinary catheter Detrusor Epidural analgesia Colectomy
1. Introduction
* Corresponding author. Dept. of Surgery, University Hospital Galway, Newcastle, Galway, Ireland. E-mail address: [email protected] (D. Coyle). 1 Present address: National Children's Research Centre, Gate 5, Our Lady's Children's Hospital, Crumlin Rd., Dublin 12, Ireland. http://dx.doi.org/10.1016/j.ijsu.2015.03.003 1743-9191/© 2015 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
Perioperative catheterisation of the urinary bladder has an important role in monitoring fluid balance in patients undergoing colorectal surgery. While several studies support the use of suprapubic catheterisation (SPC) for this purpose [1e4], urethral catheterisation (UC) remains the preferred method of urinary
D. Coyle et al. / International Journal of Surgery 16 (2015) 94e98
drainage in many institutions. UC removal facilitates early mobilisation following colorectal surgery and is a core component of most enhanced recovery/fast-track colorectal surgery programmes [5e7]. Post-operative epidural analgesia (POEA) following open colorectal surgery has several well examined benefits over systemic opiate use, in particular improved pain scores and faster return to gut function [8e10]. The same has been thought to be true of POEA following laparoscopic colorectal surgery although recent evidence suggests this may not be the case [11]. POEA is known to impact upon bladder function, with lumbar epidural analgesia being associated in the past with higher rates of post-operative urinary retention (POUR) [12]. Recovery of bladder function in patients undergoing rectal resection is thought to be slower than in those undergoing colonic resection, probably due to the close proximity of the pelvic autonomic nerves to the dissection plane in rectal resection [13,14]. Accordingly cessation of POEA should be associated with a return to normal voiding function, although several studies have found this not to be the case [14]. Thus the timing of removal of UC post-operatively in those with POEA following colorectal surgery is contentious. Conventional practise is to delay UC removal until epidural infusion is withdrawn. The risk of POUR due to delayed return of normal bladder function must be balanced against the risks of catheter associated urinary tract infection (UTI) and problems related to delayed mobilisation, such as atelectasis and an increased risk of venous thromboembolism (VTE). Catheterisation beyond 2 days is associated with a twofold increased incidence of UTI [15]. Impaired mobilisation after abdominal surgery is also associated with increased burden of morbidity, especially respiratory complications [16]. Several studies have evaluated the timing of UC removal in patients undergoing either colonic or rectal resection with and without specific reference to analgesia type [13,17e21]. For the most part these studies have supported earlier post-operative cessation of per urethral bladder drainage as a measure that aids recovery. To date, there are only a limited number of prospective studies examining rates of POUR in patients undergoing colorectal surgery whose urethral catheters are removed early while POEA is still potentially in progress [21]. The primary objective of our study was to determine if removal of the UC at 48 h following colorectal resection, regardless of ongoing POEA, altered the risk of POUR when compared to those in whom UC removal was delayed post-operatively until after POEA was withdrawn, as per traditional practice. Our secondary goal was to examine rates of other complications in these groups, including urinary tract infection, pulmonary complications, and surgical site infection. 2. Materials and methods 2.1. Study protocol A single-centre prospective randomised controlled pilot clinical study was conducted following approval from the local institutional review board (C.A. 661). Consecutive patients planned to undergo trans-abdominal colorectal surgery were invited to participate at the time of hospital admission by the admitting team. International prostate symptom scores (IPSS) were calculated for all male patients who accepted invitation to participate. Consenting individuals who satisfied the inclusion and exclusion criteria for the study were randomised using a computer generated randomisation system within 24 h of surgery to one of two parallel study arms: an experimental group (SG1) or a control group (SG2). The operator was blinded as to the allocated arm, which was contained in a sealed envelope, at the time of catheter insertion. Urethral
95
Table 1 Pre-operative and post-operative exclusion criteria governing admission to the trial. Pre-operative exclusion criteria
Post-operative exclusion criteria
Prior surgery to lower urinary tract
Epidural analgesia withdrawn 12 h post-operatively Surgical instrumentation of or dissection involving the urinary tract Delay in removal of urinary catheter due to medical necessity Pelvic sepsis at surgery Unexpected finding of entero- or rectovesical fistula at surgery Premature dislodgement of urethral catheter Failed epidural catheterisation
Pre-existing lower urinary tract disease Intermittent self catheterisation Neurogenic bladder Pregnancy Prior transabdominal pelvic surgery Known entero-vesical fistula Planned synchronous urinary tract surgery Anti-cholinergic therapy International prostate symptom score 20 Urethral catheter indwelling >24 h prior to surgery
catheters were scheduled to be removed at 48 h post-operatively in SG1 and within 12 h of withdrawal of epidural analgesia in SG2, the latter schedule reflecting traditional practice at our institution. 2.2. Admission criteria Inclusion criteria included age over 18 years old, competent to consent for research purposes, and a plan to undergo elective transabdominal colectomy, proctectomy or coloproctectomy with postoperative epidural analgesia. Pre- and post-operative exclusion criteria are detailed in Table 1. At admission to the study, basic patient demographics were recorded for all patients (Table 2) Post-operatively the following Table 2 Population and operative characteristics of study participants at admission to the trial. There were significantly more females in SG2 compared to SG1, but otherwise both study arms were well matched for age, IPSS and the proportion of rectal resections undertaken. SG1 (n ¼ 22)
Population characteristics
Male Female Age IPSS Operative characteristics Pathology at Malignancy surgery Benign tumour Diverticular disease Inflammatory bowel disease Rectal prolapse Others Operation Segmental right colectomy performed Extended right colectomy Left/sigmoid colectomy Anterior resection/ proctectomy Low anterior resection Abdominoperineal resection Total colectomy Anastomosis Ileocolic Colo-colic Colo-rectal Colo-anal Ileal pouch-anal End-stoma
SG2 (n ¼ 22)
n¼%
n¼%
20 2 63.5 4.5
10 12 62 7
16 0 1 3
17 1 0 3
0 1 6 0 4 6
1 0 3 1 2 5
3 1
5 3
1 6 2 7 2 1 2
2 4 1 8 2 1 6
p-value
p ¼ 0.001 p ¼ 0.597 p ¼ 0.1
96
D. Coyle et al. / International Journal of Surgery 16 (2015) 94e98
surgical details were recorded: Extent of surgical resection (anterior resection, left segmental colectomy etc.), level of anastomosis, type of stoma fashioned where applicable, size of urethral catheter inserted, level of epidural catheterisation, type of epidural analgesia infused, and type of pathology encountered. Post-operatively the durations of urethral and epidural catheterisation were recorded. 2.3. Primary and secondary outcomes The primary outcome examined was the development of POUR within 2 weeks of surgery. Criteria used to diagnose POUR were primarily clinical, including painful or painless inability to pass urine and palpable bladder requiring re-insertion of urethral catheter, with a residual of 400 mL being accepted as diagnostic. The study protocol encouraged the use of a portable bladder ultrasound scanner to confirm the post-void residual volume where doubt existed. Secondary outcomes assessed included the development of pulmonary complications (symptomatic atelectasis, pneumonia, pulmonary embolism), UTI, as assessed by symptomatic or asymptomatic bacteriuria, and surgical site infection (SSI). Based on the pooled incidence of POUR following abdominal, pelvic or anorectal surgery described in a detailed review by Baldini et al. (1999) [22], we expected the rate of POUR in SG1would approach 40%, while we expected a low incidence of POUR in SG2 (~5%). Thus, the study was powered at 80% to detect a 35% difference in rates of POUR between the two study arms. Thus each study arm required a sample size of 22 individuals. Statistical analysis was performed on an intention-to-treat basis using standard statistical software (SPSS v. 20.0).
were male and 14 were female. The median age at enrolment was 62.5 years (22e84 years). Basic population and treatment characteristics can be seen in Table 2. Twenty-two patients (50%) were allocated to SG1 (experimental) arm of the trial, while 22 patients (50%) were randomised to the SG2 (control) arm. There were significantly more female participants in SG2 (SG1 2 females [9.1%] vs SG2 12 females [54.5%], Fisher's Exact test p ¼ 0.003). There was no difference in median IPSS between SG1 and SG2 (SG1: 4.5 vs SG2: 7, Mann Whitney U-test, p ¼ 0.1). 3.2. Post-operative exclusions In total, 9 patients (20.5%) were excluded from analysis during the post-operative period. In SG1, 7 patients were excluded due to the following reasons: premature accidental dislodgement of urethral catheter (n ¼ 2); epidural catheter dislodgement 48 h are exposed to twice the risk of UTI as those catheterised for less than 2 days [15]. A large study involving over 54,000 colorectal cases found a higher rate of post-operative UTI with colorectal surgery (4.1%) than non-colorectal gastrointestinal surgery (1.8%) [24]. In turn, a separate study has recently highlighted the progression from UTI bacteraemia to shock in 32% of a population in which 55.7% of subjects had indwelling urinary catheters [25]. Thus focused measures are required to minimise nosocomial UTI after colorectal resection, with early removal of UC being frequently advocated to this end. The low incidence of UTI in our study, in just 1 participant whose urethra was re-catheterised for oliguria, is encouraging. In an effort to improve the generalisability of our results, our study population was heterogeneous, consisting of both males and females across a wide age spectrum, undergoing a variety of pelvic and non-pelvic colorectal procedures. The rates of POUR observed are similar to other studies, and we have also observed similar factors impacting upon the development of POUR, especially gender, age and the level at which resection takes place. In keeping with other authors [18,22], we found that male patients undergoing rectal resection appear to be most at risk of developing POUR. Of note reported IPSS scores pre-operatively were not predictive of the development of POUR, suggesting a more objective measure of voiding function is required. Some studies have established preoperative urological assessment as valuable in predicting urological dysfunction after rectal surgery [26e28]. Relatively simple noninvasive investigations such as post-void residual ultrasound scan or urinary flow rate measurement might serve as useful objective measures to determine those at higher risk of POUR, particularly in males, and facilitate implementation of appropriate pre- and postoperative measures to prevent this. Despite the putative benefits of early UC removal for early mobilisation, the incidence of respiratory complications in each study arm was broadly similar. This may reflect the effect of the epidural analgesia itself upon post-operative mobility. A randomised controlled trial comparing epidural, intra-thecal and patientcontrolled analgesia in patients undergoing laparoscopic colorectal surgery found mobility in the epidural group was significantly impaired post-operatively compared to the other groups, and also noted no advantage in pulmonary status with epidural analgesia [11]. The feasibility with which the trial protocol was implemented will allow its easy application to a larger multicentre trial. Daily ultrasonographic post-void residual bladder volume measurements following UC removal would also provide an empirical measurement detrusor function and would be a welcome addition
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D. Coyle et al. / International Journal of Surgery 16 (2015) 94e98
to the trial protocol in larger studies. The exclusion of patients with pre-existing urinary tract disease in this trial removes a major potential confounding variable in determining the true rate of POUR due to POEA in the setting of colorectal resection. 5. Conclusions This prospective pilot trial suggests that, in female patients undergoing colorectal resection and male patients undergoing colon resection, the UC may be safely removed at 48 h postoperatively irrespective of epidural use. This carries the benefit of improved mobilisation and reduced risk of UTI. Male patients undergoing rectal resection have an increased tendency for urinary retention irrespective of timing of removal of epidural. The above effect observed is worthy of a larger multi-centre study. Ethical approval Ethical approval was given by the local Clinical Research Ethics Committee (CA 661). Sources of funding None. Author contribution DC, JTG, PMN, MRJ contributed to study conception and design. MR, OJMA, MRJ contributed to implementation of the trial protocol as senior surgeons. DC, KMJ, JTG, PMN contributed to data collection. DC, PMN, MRJ contributed to drafting the manuscript. All authors reviewed and approved the final manuscript. Conflict of interest statement The authors declare no conflicts of interest. Guarantor David Coyle. Myles R. Joyce. Acknowledgements No external or internal funding or financial assistance was utilised in the performance of this study. References [1] L.C. Perrin, C. Penfold, A. McLeish, A prospective randomized controlled trial comparing suprapubic with urethral catheterization in rectal surgery, Aust. N. Z. J. Surg. 67 (1997) 554e556. [2] K.E. Klaaborg, O. Kronborg, Suprapubic bladder drainage in elective colorectal surgery, Dis. Colon Rectum 29 (1986) 260e262. [3] P.B. Christensen, O. Kronborg, Suprapubic bladder drainage in colorectal surgery, Br. J. Surg. 68 (1981) 348e349. [4] C.D. Ratnaval, P. Renwick, R. Farouk, J.R. Monson, P.W. Lee, Suprapubic versus transurethral catheterisation of males undergoing pelvic colorectal surgery, Int. J. Colorectal Dis. 11 (1996) 177e179. [5] S.J. Baek, S.H. Kim, S.Y. Kim, J.W. Shin, J.M. Kwak, J. Kim, The safety of a “fasttrack” program after laparoscopic colorectal surgery is comparable in older
patients as in younger patients, Surg. Endosc. 27 (2013) 1225e1232. [6] N.O. Kolozsvari, G. Capretti, P. Kaneva, A. Neville, F. Carli, S. Liberman, et al., Impact of an enhanced recovery program on short-term outcomes after scheduled laparoscopic colon resection, Surg. Endosc. 27 (2013) 133e138. [7] M. Scatizzi, K.C. Kroning, V. Boddi, M. De Prizio, F. Feroci, Fast-track surgery after laparoscopic colorectal surgery: is it feasible in a general surgery unit? Surgery 147 (2010) 219e226. [8] A.J. Senagore, C.P. Delaney, N. Mekhail, A. Dugan, V.W. Fazio, Randomized clinical trial comparing epidural anaesthesia and patient-controlled analgesia after laparoscopic segmental colectomy, Br. J. Surg. 90 (2003) 1195e1199. [9] C.T. Wu, S.W. Jao, C.O. Borel, C.C. Yeh, C.Y. Li, C.H. Lu, et al., The effect of epidural clonidine on perioperative cytokine response, postoperative pain, and bowel function in patients undergoing colorectal surgery, Anesth. Analg. 99 (2004) 502e509. [10] E. Marret, C. Remy, F. Bonnet, G Postoperative pain forum, Meta-analysis of epidural analgesia versus parenteral opioid analgesia after colorectal surgery, Br. J. Surg. 94 (2007) 665e673. [11] B.F. Levy, M.J. Scott, W. Fawcett, C. Fry, T.A. Rockall, Randomized clinical trial of epidural, spinal or patient-controlled analgesia for patients undergoing laparoscopic colorectal surgery, Br. J. Surg. 98 (2011) 1068e1078. [12] T.A. Torda, D.A. Pybus, Comparison of four narcotic analgesics for extradural analgesia, Br. J. Anaesth. 54 (1982) 291e295. [13] C.R. Changchien, C.Y. Yeh, S.T. Huang, M.L. Hsieh, J.S. Chen, R. Tang, Postoperative urinary retention after primary colorectal cancer resection via laparotomy: a prospective study of 2,355 consecutive patients, Dis. Colon Rectum 50 (2007) 1688e1696. [14] S. Chaudhri, K. Maruthachalam, A. Kaiser, W. Robson, R.S. Pickard, A.F. Horgan, Successful voiding after trial without catheter is not synonymous with recovery of bladder function after colorectal surgery, Dis. Colon Rectum 49 (2006) 1066e1070. [15] H.L. Wald, A. Ma, D.W. Bratzler, A.M. Kramer, Indwelling urinary catheter use in the postoperative period: analysis of the national surgical infection prevention project data, Arch. Surg. 143 (2008) 551e557. [16] S.M. Soares, L.B. Nucci, M.M. da Silva, T.C. Campacci, Pulmonary function and physical performance outcomes with preoperative physical therapy in upper abdominal surgery: a randomized controlled trial, Clin. Rehabil. 27 (2013) 616e627. [17] O. Zmora, K. Madbouly, H. Tulchinsky, A. Hussein, M. Khaikin, Urinary bladder catheter drainage following pelvic surgeryeis it necessary for that long? Dis. Colon Rectum 53 (2010) 321e326. [18] S. Benoist, Y. Panis, C. Denet, F. Mauvais, P. Mariani, P. Valleur, Optimal duration of urinary drainage after rectal resection: a randomized controlled trial, Surgery 125 (1999) 135e141. [19] L. Basse, M. Werner, H. Kehlet, Is urinary drainage necessary during continuous epidural analgesia after colonic resection? Reg. Anesth. Pain Med. 25 (2000) 498e501. [20] C. Kin, K.F. Rhoads, M. Jalali, A.A. Shelton, M.L. Welton, Predictors of postoperative urinary retention after colorectal surgery, Dis. Colon Rectum 56 (2013) 738e746. [21] B.M. Stubbs, K.J. Badcock, C. Hyams, F.E. Rizal, S. Warren, D. Francis, A prospective study of early removal of the urethral catheter after colorectal surgery in patients having epidural analgesia as part of the enhanced recovery after surgery programme, Colorectal Dis. 15 (2013) 733e736. [22] G. Baldini, H. Bagry, A. Aprikian, F. Carli, Postoperative urinary retention: anesthetic and perioperative considerations, Anesthesiology 110 (2009) 1139e1157. [23] T. Tammela, M. Kontturi, O. Lukkarinen, Postoperative urinary retention. I. Incidence and predisposing factors, Scand. J. Urol. Nephrol. 20 (1986) 197e201. [24] S.E. Regenbogen, T.E. Read, P.L. Roberts, P.W. Marcello, D.J. Schoetz, R. Ricciardi, Urinary tract infection after colon and rectal resections: more common than predicted by risk-adjustment models, J. Am. Coll. Surg. 213 (2011) 784e792. [25] K. Shigemura, K. Tanaka, K. Osawa, S. Arakawa, H. Miyake, M. Fujisawa, Clinical factors associated with shock in bacteremic UTI, Int. Urol. Nephrol. 45 (2013) 653e657. [26] D.E. Neal, N.S. Williams, D. Johnston, A prospective study of bladder function before and after sphincter-saving resections for low carcinoma of the rectum, Br. J. Urol. 53 (1981) 558e564. [27] P. Sterk, B. Shekarriz, S. Gunter, J. Nolde, R. Keller, H.P. Bruch, et al., Voiding and sexual dysfunction after deep rectal resection and total mesorectal excision: prospective study on 52 patients, Int. J. Colorectal Dis. 20 (2005) 423e427. [28] T.C. Gerstenberg, M.L. Nielsen, S. Clausen, J. Blaabjerg, J. Lindenberg, Bladder function after abdominoperineal resection of the rectum for anorectal cancer. Urodynamic investigation before and after operative in a consecutive series, Ann. Surg. 191 (1980) 81e86.
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Original research
Early post-operative removal of urethral catheter in patients undergoing colorectal surgery with epidural analgesia e A prospective pilot clinical study David Coyle*, 1, Kenneth M. Joyce, Joseph T. Garvin, Mark Regan, Oliver J. McAnena, Peter M. Neary, Myles R. Joyce Department of Surgery, University Hospital Galway, Newcastle, Galway, Ireland
h i g h l i g h t s We examine the timing of UC removal in colorectal surgery with epidural analgesia. This randomised clinical trial compares early removal with standard timing. The risk of urinary retention is similar in both study arms. Urinary retention only occurred in males undergoing rectal resection. This pilot clinical trial shows early UC removal is safe in females and some males.
a r t i c l e i n f o
a b s t r a c t
Article history: Received 29 October 2014 Accepted 3 March 2015 Available online 10 March 2015
Background: Urethral catheter (UC) removal is often delayed following colorectal resection due to the perceived increased risk of post-operative urinary retention (POUR) in patients with post-operative epidural analgesia (POEA). We aimed to determine if UC removal at 48 h, irrespective of ongoing POEA use, altered the risk of POUR and other morbidities associated with urethral catheterisation and immobility. Methods: We performed a prospective randomised controlled pilot clinical study. Eligible patients were randomised to an experimental arm, SG1 (UC removal 48 h post-operatively), or a control arm, SG2 (UC removed following cessation of POEA). Rates of POUR, urinary tract infection (UTI), pulmonary complications and surgical site infection (SSI) were recorded. Forty-four patients were recruited (SG1: n ¼ 22; SG2: n ¼ 22). Results: No females developed POUR, while it occurred in three males (20%) in SG1 and 2 males (22.2%) in SG2. All patients who developed POUR had undergone rectal resection. Males in SG1 were not at significantly increased risk of POUR compared to those in SG2 (R.R 0.875, p ¼ 1). No patient developed UTI post-operatively. The rate of pulmonary complications (SG1: n ¼ 2; SG2: n ¼ 3, p ¼ 0.229) and SSI (SG1: n ¼ 5; SG2: n ¼ 2, p ¼ 0.146) were similar between both study arms. Discussion: Males undergoing rectal surgery appear to be at increased risk of developing POUR in the presence of epidural analgesia, independent of the timing of UC removal. Conclusions: All female patients undergoing colorectal resection and male patients undergoing colonic resection may have their urethral catheter removed at 48 h irrespective of use of POEA. Clinical trials registration number: NCT01508767 (http://www.clinicaltrials.gov). © 2015 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
Keywords: Post-operative urinary retention Colorectal Urinary catheter Detrusor Epidural analgesia Colectomy
1. Introduction
* Corresponding author. Dept. of Surgery, University Hospital Galway, Newcastle, Galway, Ireland. E-mail address: [email protected] (D. Coyle). 1 Present address: National Children's Research Centre, Gate 5, Our Lady's Children's Hospital, Crumlin Rd., Dublin 12, Ireland. http://dx.doi.org/10.1016/j.ijsu.2015.03.003 1743-9191/© 2015 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
Perioperative catheterisation of the urinary bladder has an important role in monitoring fluid balance in patients undergoing colorectal surgery. While several studies support the use of suprapubic catheterisation (SPC) for this purpose [1e4], urethral catheterisation (UC) remains the preferred method of urinary
D. Coyle et al. / International Journal of Surgery 16 (2015) 94e98
drainage in many institutions. UC removal facilitates early mobilisation following colorectal surgery and is a core component of most enhanced recovery/fast-track colorectal surgery programmes [5e7]. Post-operative epidural analgesia (POEA) following open colorectal surgery has several well examined benefits over systemic opiate use, in particular improved pain scores and faster return to gut function [8e10]. The same has been thought to be true of POEA following laparoscopic colorectal surgery although recent evidence suggests this may not be the case [11]. POEA is known to impact upon bladder function, with lumbar epidural analgesia being associated in the past with higher rates of post-operative urinary retention (POUR) [12]. Recovery of bladder function in patients undergoing rectal resection is thought to be slower than in those undergoing colonic resection, probably due to the close proximity of the pelvic autonomic nerves to the dissection plane in rectal resection [13,14]. Accordingly cessation of POEA should be associated with a return to normal voiding function, although several studies have found this not to be the case [14]. Thus the timing of removal of UC post-operatively in those with POEA following colorectal surgery is contentious. Conventional practise is to delay UC removal until epidural infusion is withdrawn. The risk of POUR due to delayed return of normal bladder function must be balanced against the risks of catheter associated urinary tract infection (UTI) and problems related to delayed mobilisation, such as atelectasis and an increased risk of venous thromboembolism (VTE). Catheterisation beyond 2 days is associated with a twofold increased incidence of UTI [15]. Impaired mobilisation after abdominal surgery is also associated with increased burden of morbidity, especially respiratory complications [16]. Several studies have evaluated the timing of UC removal in patients undergoing either colonic or rectal resection with and without specific reference to analgesia type [13,17e21]. For the most part these studies have supported earlier post-operative cessation of per urethral bladder drainage as a measure that aids recovery. To date, there are only a limited number of prospective studies examining rates of POUR in patients undergoing colorectal surgery whose urethral catheters are removed early while POEA is still potentially in progress [21]. The primary objective of our study was to determine if removal of the UC at 48 h following colorectal resection, regardless of ongoing POEA, altered the risk of POUR when compared to those in whom UC removal was delayed post-operatively until after POEA was withdrawn, as per traditional practice. Our secondary goal was to examine rates of other complications in these groups, including urinary tract infection, pulmonary complications, and surgical site infection. 2. Materials and methods 2.1. Study protocol A single-centre prospective randomised controlled pilot clinical study was conducted following approval from the local institutional review board (C.A. 661). Consecutive patients planned to undergo trans-abdominal colorectal surgery were invited to participate at the time of hospital admission by the admitting team. International prostate symptom scores (IPSS) were calculated for all male patients who accepted invitation to participate. Consenting individuals who satisfied the inclusion and exclusion criteria for the study were randomised using a computer generated randomisation system within 24 h of surgery to one of two parallel study arms: an experimental group (SG1) or a control group (SG2). The operator was blinded as to the allocated arm, which was contained in a sealed envelope, at the time of catheter insertion. Urethral
95
Table 1 Pre-operative and post-operative exclusion criteria governing admission to the trial. Pre-operative exclusion criteria
Post-operative exclusion criteria
Prior surgery to lower urinary tract
Epidural analgesia withdrawn 12 h post-operatively Surgical instrumentation of or dissection involving the urinary tract Delay in removal of urinary catheter due to medical necessity Pelvic sepsis at surgery Unexpected finding of entero- or rectovesical fistula at surgery Premature dislodgement of urethral catheter Failed epidural catheterisation
Pre-existing lower urinary tract disease Intermittent self catheterisation Neurogenic bladder Pregnancy Prior transabdominal pelvic surgery Known entero-vesical fistula Planned synchronous urinary tract surgery Anti-cholinergic therapy International prostate symptom score 20 Urethral catheter indwelling >24 h prior to surgery
catheters were scheduled to be removed at 48 h post-operatively in SG1 and within 12 h of withdrawal of epidural analgesia in SG2, the latter schedule reflecting traditional practice at our institution. 2.2. Admission criteria Inclusion criteria included age over 18 years old, competent to consent for research purposes, and a plan to undergo elective transabdominal colectomy, proctectomy or coloproctectomy with postoperative epidural analgesia. Pre- and post-operative exclusion criteria are detailed in Table 1. At admission to the study, basic patient demographics were recorded for all patients (Table 2) Post-operatively the following Table 2 Population and operative characteristics of study participants at admission to the trial. There were significantly more females in SG2 compared to SG1, but otherwise both study arms were well matched for age, IPSS and the proportion of rectal resections undertaken. SG1 (n ¼ 22)
Population characteristics
Male Female Age IPSS Operative characteristics Pathology at Malignancy surgery Benign tumour Diverticular disease Inflammatory bowel disease Rectal prolapse Others Operation Segmental right colectomy performed Extended right colectomy Left/sigmoid colectomy Anterior resection/ proctectomy Low anterior resection Abdominoperineal resection Total colectomy Anastomosis Ileocolic Colo-colic Colo-rectal Colo-anal Ileal pouch-anal End-stoma
SG2 (n ¼ 22)
n¼%
n¼%
20 2 63.5 4.5
10 12 62 7
16 0 1 3
17 1 0 3
0 1 6 0 4 6
1 0 3 1 2 5
3 1
5 3
1 6 2 7 2 1 2
2 4 1 8 2 1 6
p-value
p ¼ 0.001 p ¼ 0.597 p ¼ 0.1
96
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surgical details were recorded: Extent of surgical resection (anterior resection, left segmental colectomy etc.), level of anastomosis, type of stoma fashioned where applicable, size of urethral catheter inserted, level of epidural catheterisation, type of epidural analgesia infused, and type of pathology encountered. Post-operatively the durations of urethral and epidural catheterisation were recorded. 2.3. Primary and secondary outcomes The primary outcome examined was the development of POUR within 2 weeks of surgery. Criteria used to diagnose POUR were primarily clinical, including painful or painless inability to pass urine and palpable bladder requiring re-insertion of urethral catheter, with a residual of 400 mL being accepted as diagnostic. The study protocol encouraged the use of a portable bladder ultrasound scanner to confirm the post-void residual volume where doubt existed. Secondary outcomes assessed included the development of pulmonary complications (symptomatic atelectasis, pneumonia, pulmonary embolism), UTI, as assessed by symptomatic or asymptomatic bacteriuria, and surgical site infection (SSI). Based on the pooled incidence of POUR following abdominal, pelvic or anorectal surgery described in a detailed review by Baldini et al. (1999) [22], we expected the rate of POUR in SG1would approach 40%, while we expected a low incidence of POUR in SG2 (~5%). Thus, the study was powered at 80% to detect a 35% difference in rates of POUR between the two study arms. Thus each study arm required a sample size of 22 individuals. Statistical analysis was performed on an intention-to-treat basis using standard statistical software (SPSS v. 20.0).
were male and 14 were female. The median age at enrolment was 62.5 years (22e84 years). Basic population and treatment characteristics can be seen in Table 2. Twenty-two patients (50%) were allocated to SG1 (experimental) arm of the trial, while 22 patients (50%) were randomised to the SG2 (control) arm. There were significantly more female participants in SG2 (SG1 2 females [9.1%] vs SG2 12 females [54.5%], Fisher's Exact test p ¼ 0.003). There was no difference in median IPSS between SG1 and SG2 (SG1: 4.5 vs SG2: 7, Mann Whitney U-test, p ¼ 0.1). 3.2. Post-operative exclusions In total, 9 patients (20.5%) were excluded from analysis during the post-operative period. In SG1, 7 patients were excluded due to the following reasons: premature accidental dislodgement of urethral catheter (n ¼ 2); epidural catheter dislodgement 48 h are exposed to twice the risk of UTI as those catheterised for less than 2 days [15]. A large study involving over 54,000 colorectal cases found a higher rate of post-operative UTI with colorectal surgery (4.1%) than non-colorectal gastrointestinal surgery (1.8%) [24]. In turn, a separate study has recently highlighted the progression from UTI bacteraemia to shock in 32% of a population in which 55.7% of subjects had indwelling urinary catheters [25]. Thus focused measures are required to minimise nosocomial UTI after colorectal resection, with early removal of UC being frequently advocated to this end. The low incidence of UTI in our study, in just 1 participant whose urethra was re-catheterised for oliguria, is encouraging. In an effort to improve the generalisability of our results, our study population was heterogeneous, consisting of both males and females across a wide age spectrum, undergoing a variety of pelvic and non-pelvic colorectal procedures. The rates of POUR observed are similar to other studies, and we have also observed similar factors impacting upon the development of POUR, especially gender, age and the level at which resection takes place. In keeping with other authors [18,22], we found that male patients undergoing rectal resection appear to be most at risk of developing POUR. Of note reported IPSS scores pre-operatively were not predictive of the development of POUR, suggesting a more objective measure of voiding function is required. Some studies have established preoperative urological assessment as valuable in predicting urological dysfunction after rectal surgery [26e28]. Relatively simple noninvasive investigations such as post-void residual ultrasound scan or urinary flow rate measurement might serve as useful objective measures to determine those at higher risk of POUR, particularly in males, and facilitate implementation of appropriate pre- and postoperative measures to prevent this. Despite the putative benefits of early UC removal for early mobilisation, the incidence of respiratory complications in each study arm was broadly similar. This may reflect the effect of the epidural analgesia itself upon post-operative mobility. A randomised controlled trial comparing epidural, intra-thecal and patientcontrolled analgesia in patients undergoing laparoscopic colorectal surgery found mobility in the epidural group was significantly impaired post-operatively compared to the other groups, and also noted no advantage in pulmonary status with epidural analgesia [11]. The feasibility with which the trial protocol was implemented will allow its easy application to a larger multicentre trial. Daily ultrasonographic post-void residual bladder volume measurements following UC removal would also provide an empirical measurement detrusor function and would be a welcome addition
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to the trial protocol in larger studies. The exclusion of patients with pre-existing urinary tract disease in this trial removes a major potential confounding variable in determining the true rate of POUR due to POEA in the setting of colorectal resection. 5. Conclusions This prospective pilot trial suggests that, in female patients undergoing colorectal resection and male patients undergoing colon resection, the UC may be safely removed at 48 h postoperatively irrespective of epidural use. This carries the benefit of improved mobilisation and reduced risk of UTI. Male patients undergoing rectal resection have an increased tendency for urinary retention irrespective of timing of removal of epidural. The above effect observed is worthy of a larger multi-centre study. Ethical approval Ethical approval was given by the local Clinical Research Ethics Committee (CA 661). Sources of funding None. Author contribution DC, JTG, PMN, MRJ contributed to study conception and design. MR, OJMA, MRJ contributed to implementation of the trial protocol as senior surgeons. DC, KMJ, JTG, PMN contributed to data collection. DC, PMN, MRJ contributed to drafting the manuscript. All authors reviewed and approved the final manuscript. Conflict of interest statement The authors declare no conflicts of interest. Guarantor David Coyle. Myles R. Joyce. Acknowledgements No external or internal funding or financial assistance was utilised in the performance of this study. References [1] L.C. Perrin, C. Penfold, A. McLeish, A prospective randomized controlled trial comparing suprapubic with urethral catheterization in rectal surgery, Aust. N. Z. J. Surg. 67 (1997) 554e556. [2] K.E. Klaaborg, O. Kronborg, Suprapubic bladder drainage in elective colorectal surgery, Dis. Colon Rectum 29 (1986) 260e262. [3] P.B. Christensen, O. Kronborg, Suprapubic bladder drainage in colorectal surgery, Br. J. Surg. 68 (1981) 348e349. [4] C.D. Ratnaval, P. Renwick, R. Farouk, J.R. Monson, P.W. Lee, Suprapubic versus transurethral catheterisation of males undergoing pelvic colorectal surgery, Int. J. Colorectal Dis. 11 (1996) 177e179. [5] S.J. Baek, S.H. Kim, S.Y. Kim, J.W. Shin, J.M. Kwak, J. Kim, The safety of a “fasttrack” program after laparoscopic colorectal surgery is comparable in older
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