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Prospective comparison of short-term convalescence: laparoscopic radical prostatectomy versus open radical retropubic prostatectomy
ADULT UROLOGY CME ARTICLE
PROSPECTIVE COMPARISON OF SHORT-TERM CONVALESCENCE: LAPAROSCOPIC RADICAL PROSTATECTOMY VERSUS OPEN RADICAL RETROPUBIC PROSTATECTOMY SAM B. BHAYANI, CHRISTIAN P. PAVLOVICH, THOMAS S. HSU, WENDY SULLIVAN, LI-MING SU
AND
ABSTRACT Objectives. To evaluate and compare prospectively the convalescence of patients after laparoscopic radical prostatectomy (LRP) and open radical retropubic prostatectomy (RRP) in a standardized clinical care pathway at a single institution by two surgeons of equal experience and training. Methods. The study included all 60 patients undergoing LRP and RRP by two fellowship-trained surgeons in their first year of practice. The postoperative care of these patients was uniform and standardized. The medical records were reviewed and convalescence data obtained by an independent urologist and physician’s assistant. Results. Of the 60 patients, 24 underwent RRP and 36 underwent attempted LRP; 3 patients were converted from LRP to RRP. The differences in mean age, preoperative prostate-specific antigen level, Gleason score, in-hospital morphine equivalent requirement, time to oral intake, and hospital stay were not statistically significant between the LRP and RRP groups. The operating room time was significantly longer (5.8 ⫾ 1.2 hours versus 2.8 ⫾ 0.55 hours, P ⬍0.0001) and the estimated blood loss was significantly lower in the LRP group (533 ⫾ 212 mL versus 1473 ⫾ 768 mL, P ⬍0.0001) than in the RRP group. Pain medication use at home was significantly less in the LRP group (9 ⫾ 13 versus 17 ⫾ 15 oxycodone tablets, P ⬍0.04), as was the time to complete convalescence (30 ⫾ 18 days versus 47 ⫾ 21 days, P ⬍0.002). Conclusions. Although LRP took almost twice as long to complete as RRP in our initial clinical experience, the patients had a similar hospital course. LRP patients required less pain medication after discharge and had a shorter time to complete recovery than did RRP patients. Additional studies are needed to address long-term cancer control, potency, and continence outcomes to determine the precise role of LRP in the treatment of men with clinically localized prostate cancer. UROLOGY 61: 612–616, 2003. © 2003, Elsevier Science Inc.
T
he benefits of laparoscopy as a minimally invasive surgical technique have been well documented in urologic published reports. Patients undergoing laparoscopic nephrectomy, nephroureterectomy, and adrenalectomy have all enjoyed a shorter hospital stay, less postoperative pain, and improved cosmesis than patients undergoing open surgery.1–3 In addition, the reduction in the time of
From the James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore, Maryland Reprint requests: Li-Ming Su, M.D., Department of Urology, Section of Pelvic Laparoscopy and Stone Disease, Johns Hopkins Bayview Medical Center, 4940 Eastern Avenue, Room A345, Baltimore, MD 21224 Submitted: September 6, 2002, accepted (with revisions): October 25, 2002
612
© 2003, ELSEVIER SCIENCE INC. ALL RIGHTS RESERVED
convalescence has popularized these laparoscopic procedures. Radical prostatectomy remains the standard of care for the surgical treatment of patients with clinically localized prostate cancer. Laparoscopic radical prostatectomy (LRP) has recently emerged as an alternative technique to open radical retropubic prostatectomy (RRP); however, a critical comparison of convalescence after these two techniques has yet to be reported.4 – 6 The lower midline incision associated with open RRP is not as strikingly debilitating as the flank incision used for open nephrectomy or adrenalectomy. Therefore, the convalescence benefits of laparoscopic prostatectomy may not be as marked as those of laparoscopic nephrectomy or adrenalectomy. 0090-4295/03/$30.00 doi:10.1016/S0090-4295(02)02416-0
In this study, we prospectively compared the contemporaneous short-term convalescence of patients after open RRP and LRP using a standardized postoperative management protocol at a single institution with the operations performed by two surgeons with comparable years of experience and training. MATERIAL AND METHODS PATIENTS All patients undergoing RRP and LRP at Johns Hopkins Bayview Medical Center between July 2001 and June 2002 performed by two fellowship-trained surgeons (C.P.P. [urologic oncology fellowship with laparoscopic experience] and L.S. [laparoscopy/endourology fellowship]) in their first year of clinical practice were included in the study. Patients were counseled preoperatively on the risks and benefits of all options for treatment of prostate cancer, including both LRP and RRP. Patients who chose the open approach underwent a conventional RRP, as described by Walsh.7 Patients undergoing LRP underwent a transperitoneal operation, as described by Guillonneau and Vallancien.8
POSTOPERATIVE MANAGEMENT PROTOCOL The postoperative care was standardized for all patients according to the institutional clinical care pathway. All patients received a narcotic intravenous patient-controlled analgesia pump after surgery for management of their postoperative pain. Patients started taking a clear liquid diet on day 1 and advanced to a regular diet on day 2. All patients received a bisacodyl suppository on days 1 and 2 and were advised to ambulate with assistance starting on day 1. The method of pain control was converted to oral oxycodone when patients were tolerating a regular diet. All patients were discharged when tolerating a regular diet and ambulating independently. In the LRP group, a cystogram was routinely performed on day 7, and the Foley catheter was removed if no extravasation was present. If extravasation was present, a cystogram was repeated every 5 to 7 days until no extravasation was documented. In the RRP group, the catheter stayed in for 14 to 21 days depending on scheduling considerations.
DATA ACQUISITION The patient records were analyzed for clinical characteristics, operative information, and postoperative data. An independent urologist and a physician’s assistant, neither of whom had been involved in the patients’ care, obtained convalescence data. Partial convalescence was defined as the patient regaining independence and no longer requiring assistance from others with routine daily tasks. Full recovery was defined as the patient regaining complete physical strength with recovery to the preoperative state, including return to work, with the exceptions of urinary control and potency. Major complications were defined as those requiring a return to the operating room during the study period or prolonged hospitalization. Minor complications were those that were manageable in the office and/or had no clinical sequelae. No patients received postoperative radiation or hormonal therapy during the study period. Three patients who underwent conversion from the laparoscopic technique to an open procedure were excluded from analysis.
STATISTICAL ANALYSIS
The results are reported as the mean ⫾ standard deviation and were compared using the Student two-tailed t test. ComUROLOGY 61 (3), 2003
parisons were considered statistically significant with a P value of less than 0.05.
RESULTS Twenty-four patients underwent RRP and 36 underwent attempted LRP. Three patients in the LRP group were converted to RRP. The patient preoperative and operative characteristics are listed in Table I. The differences in mean age, preoperative prostate-specific antigen level, and Gleason score were not statistically significant between the LRP and RRP groups. The distribution of clinical and pathologic stages was similar between the two groups. Patients in the RRP group had a significantly shorter mean operative time of 2.8 ⫾ 0.55 hours versus 5.8 ⫾ 1.2 hours for the LRP group (P ⬍0.0001). The LRP patients had significantly less blood loss (533 ⫾ 212 mL versus 1473 ⫾ 768 mL) than the RRP patients (P ⬍0.0001). The postoperative data are summarized in Table II. No statistically significant differences were observed in the time to first oral intake, length of hospital stay, or morphine equivalent requirement during hospitalization. After discharge from the hospital, patients in the LRP group used significantly fewer oxycodone tablets (9 ⫾ 13 tablets versus 17 ⫾ 15 tablets, P ⬍0.04) and had a shorter time to partial convalescence (12 ⫾ 8 days versus 21 ⫾ 14 days, P ⬍0.004) and full recovery (30 ⫾ 18 days versus 47 ⫾ 21 days, P ⬍0.002) compared with patients in the RRP group. The LRP group also had a shorter catheterization time (14 ⫾ 6.9 days versus 19 ⫾ 1.2 days, P ⬍0.004). The incidence of both major and minor complications was comparable between the two groups. In the RRP group, 3 patients (12.5%) experienced bladder neck contractures requiring operative bladder neck incision (classified as major complications). In the LRP group, two major complications (6%) occurred. One patient developed left flank pain postoperatively and was found to have hydroureteronephrosis on intravenous urography with culmination of contrast to the ureterovesical junction. A nephrostomy tube was initially placed and later changed cystoscopically to a ureteral stent. Cystoscopy revealed edema at the left ureteral orifice from proximity to the urethrovesical anastomosis. After 1 month, the ureteral stent was removed, and a repeat intravenous urogram demonstrated complete resolution of the obstruction. The second major complication in the LRP group involved a dislodged Foley catheter requiring cystoscopic replacement on postoperative day 1. In the RRP group, two minor complications (8.3%) occurred. They were mild contractures of the bladder neck managed with dilation in the office, with no further sequelae. In the LRP group, 5 minor complications 613
TABLE I. Clinical, operative, and pathologic characteristics of patients Characteristic Mean age (yr) Mean PSA (ng/mL) Mean Gleason score on biopsy Race (n) AA H W Preoperative clinical stage (n) T1a T1c T2a T2b OR time (hr) EBL (mL) Final pathologic stage (n) T0 T2 T3a T3b
RRP (n ⴝ 24)
LRP (n ⴝ 33)
P Value
60.5 ⫾ 6.4 8.60 ⫾ 9.1 6.13 ⫾ 0.44
57.4 ⫾ 6.3 6.74 ⫾ 3.8 6.06 ⫾ 0.25
0.08 0.29 0.48 —
7 1 16
5 0 28
1 14 8 1 2.8 ⫾ 0.55 1473 ⫾ 768
0 21 11 1 5.8 ⫾ 1.2 533 ⫾ 212
1 14 6 3
0 26 6 1
—
⬍0.0001 ⬍0.0001 —
KEY: RRP ⫽ radical retropubic prostatectomy; LRP ⫽ laparoscopic radical prostatectomy; PSA ⫽ prostate-specific antigen; AA ⫽ African American; H ⫽ Hispanic; W ⫽ white; OR ⫽ operating room; EBL ⫽ estimated blood loss.
TABLE II. Convalescence and complications Time to first oral intake (days) Length of stay (days) Morphine equivalent requirement (mg) Major complications (n) Minor complications (n) Catheterization (days) Tablets of oxycodone used at home (n) Partial convalescence (days) Full recovery (days)
RRP (n ⴝ 24)
LRP (n ⴝ 33)
P Value
1⫾0 3.04 ⫾ 0.21 45 ⫾ 35 3 (12.5%) 2 (8.3%) 19 ⫾ 1.22 17 ⫾ 15 21 ⫾ 14 47 ⫾ 21
1.03 ⫾ 0.17 2.97 ⫾ 0.55 53 ⫾ 46 2 (6.1%) 5 (15.1%) 14 ⫾ 6.9 9 ⫾ 13 12 ⫾ 8 30 ⫾ 18
0.40 0.53 0.44 — — ⬍0.004 ⬍0.04 ⬍0.004 ⬍0.002
Abbreviations as in Table I.
(15.1%) developed, including calf myositis, obturator nerve palsy, postoperative hydrocele, epigastric artery injury, and inadvertent cystotomy; all were without sequelae. Three of 36 patients (8.3%) were converted from LRP to RRP. The reasons for conversion included hypercarbia in 1 patient, a suspected bladder injury in 1 patient that, after open conversion, was not found to be present, and a failure to progress during the posterior prostatic dissection owing to dense adhesions in 1 patient. None of these conversions was emergent or the result of a major surgical injury. COMMENT LRP is a relatively new technique for the surgical treatment of clinically localized prostate cancer 614
and has recently gained interest in Europe and the United States.4,9,10 Although LRP is a feasible procedure, its superiority over the open approach has not yet been demonstrated. The benefits of a shorter hospital stay, reduced postoperative pain, and shorter convalescence have been well demonstrated in comparisons between patients undergoing laparoscopic and open nephrectomy, nephroureterectomy, and adrenalectomy.1–3 To our knowledge, a critical assessment and comparison of short-term convalescence between RRP and LRP in the United States has not yet been published. Performing a comparative study of convalescence after RRP and LRP is difficult for two reasons. First, a comparison of the results after laparoscopic and open radical prostatectomy may be UROLOGY 61 (3), 2003
influenced by the experience of the surgeons involved. Although large series of open RRPs have been generated, it may not be valid to compare the latest results of an experienced open surgeon to that of a laparoscopist just beginning to perform LRP. As such, a prospective comparison of RRP and LRP performed by surgeons with a similar level of experience is desirable to assess the shortterm convalescence and outcomes accurately between the two groups. In the current study, comparisons were made between two surgeons who had both completed identical 6-year (2 years general surgery and 4 years urology) urology residencies and postgraduate fellowship training in urologic oncology (C.P.P.) and laparoscopy/endourology (L.S.). Furthermore, this study compared the early clinical experience of both surgeons in their first year of practice at a single institution. Second, comparisons between open RRP and LRP may be limited by differences in postoperative management. At our institution, highvolume prostate cancer surgery has allowed for the development of specific clinical pathways for the care of the radical prostatectomy patient. Such pathways have optimized and standardized postoperative care11 and were used in the care of both LRP and open RRP patients alike, thus limiting bias in perioperative care. In this standardized environment, no differences were found during hospitalization in terms of pain medication requirements, time to first oral intake, and length of hospitalization between the LRP and RRP patients. However, once discharged from the hospital, patients in the LRP group enjoyed significant advantages compared with the RRP group. Patients in the LRP group became independent of caregivers (12 versus 21 days) and achieved a complete recovery (30 versus 47 days) faster than did the RRP group. Additionally, the LRP group used less pain medicine at home than did the RRP group (9 versus 17 tablets). We were deliberately conservative in the treatment of both the LRP and the RRP patients. U.S. surgeons have shown shorter lengths of hospital stay after RRP and LRP.9,12 However, because this study reflected the early experience of both surgeons, patients were not encouraged to leave the hospital before postoperative day 3. The use of ketorolac, aggressive advancement of diet, and discharge to a local hotel could perhaps have shortened the hospitalization of both groups. However, it is unclear whether these changes influence the posthospital recovery time. Others have also advocated shorter periods of catheterization in both LRP and RRP.4,13 Again, because this was our initial experience, we were conservative and maintained catheterization for a mean of 14 days in the LRP group and 19 days in the RRP group. It is UROLOGY 61 (3), 2003
possible that a shorter length of catheterization could have influenced the convalescence of the LRP group. Several other factors could explain the different outcomes noted between the LRP and RRP groups in our study. Patients in the LRP group enjoyed significantly less blood loss than the RRP group. Investigators with more experience with the techniques have reported less blood loss in both LRP and RRP, and these changes could influence future outcomes.4,14 Another theoretical confounding factor could be that patients undergoing LRP may have expected a shorter convalescence because of the less invasive approach. Patients’ psychological expectations of the stress and pain associated with surgery may have influenced their perceived recovery time. Finally, patients who underwent LRP had a different geographic distribution than patients who underwent RRP. Only 20% of the LRP group lived in the Baltimore metropolitan area versus 75% of the RRP group. It is possible that if more LRP patients lived locally, they would have been more comfortable leaving the hospital earlier. Three patients underwent open conversion from LRP to RRP. Our conversion rate of 8.3% (3 of 36) is comparable to the initial experiences of other groups performing LRP.15,16 Because this study was designed to specifically address the convalescence of patients after LRP compared with RRP, we elected not to place these patients in either group, because they underwent transperitoneal laparoscopy followed by open radical prostatectomy. The postoperative course and convalescence for all 3 patients was similar to the open RRP cohort, and none of the patients had any long-term sequelae from their conversion. A comparison of our findings of improved convalescence after LRP with other published series is difficult, because no other series have been published from the United States. In one European series, patients stayed in the hospital until the Foley catheter was removed, which was a longer length of time after RRP than LRP (15 days versus 7 days).10 Comparison with the current series is also difficult because differences in healthcare delivery and cultural factors confound analysis. Radical prostatectomy is a technically challenging operation with a steep learning curve. Nevertheless, despite the significantly longer operative time for LRP in our initial experience, patients appear to benefit from less postoperative pain and an overall shorter convalescence compared with RRP. With more experience and with the use of ketorolac for postoperative pain, we are now routinely accomplishing LRP in 4 to 5 hours, discharging patients by postoperative day 2, and removing the urethral catheter by postoperative day 7. These changes are likely to translate to further benefits 615
for patients who select LRP as their surgical treatment of choice for prostate cancer, although comparable advantages may also be reached in the RRP group. Despite the advantages of improved convalescence, we contend that LRP must demonstrate comparable long-term cancer control, continence, and potency rates before it is fully accepted as an equivalent surgical technique to RRP. Additional long-term studies and larger series are necessary to support or refute this possibility. CONCLUSIONS Using a standardized postoperative clinical care protocol and comparing the results of two fellowship-trained surgeons in their early experience, LRP appears to offer patients significant advantages over RRP. These include a reduced pain medication requirement and a faster return to partial and full recovery, without an increased incidence of complications. Additional studies documenting long-term cancer control, continence, and potency are necessary to substantiate fully the role of LRP in the surgical treatment of patients with clinically localized prostate cancer. REFERENCES 1. Dunn MD, Portis AJ, Shalhav AL, et al: Laparoscopic versus open radical nephrectomy: a 9-year experience. J Urol 164: 1153–1159, 2000. 2. Shalhav AL, Dunn MD, Portis AJ, et al: Laparoscopic nephroureterectomy for upper tract transitional cell cancer: the Washington University experience. J Urol 163: 1100 –1104, 2000. 3. Gill IS: The case for laparoscopic adrenalectomy. J Urol 166: 429 –436, 2001.
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4. Guillonneau B, Cathelineau X, Doublet J, et al: Laparoscopic radical prostatectomy: assessment after 550 procedures. Crit Rev Oncol Hematol 43: 123–126, 2002. 5. Cadeddu JA, and Kavoussi LR: Laparoscopic radical prostatectomy: is it feasible and reasonable? Urol Clin North Am 28: 655–661, 2001. 6. Andriole GL: Laparoscopic radical prostatectomy: con. Urology 58: 506 –507, 2001. 7. Walsh PC: Anatomic radical retropubic prostatectomy, in Walsh PC, Retik AB, Vaughan ED, et al (Eds): Campbell’s Urology. Philadelphia, WB Saunders, 2002, vol 4, pp 3107– 3130. 8. Guillonneau B, and Vallancien G: Laparoscopic radical prostatectomy: the Montsouris technique. J Urol 163: 1643– 1649, 2000. 9. Menon M, Shrivastava A, Tewari A, et al: Laparoscopic and robot assisted radical prostatectomy: establishment of a structured program and preliminary analysis of outcomes. J Urol 168: 945–949, 2002. 10. Salomon L, Levrel O, de la Taille A, et al: Radical prostatectomy by the retropubic, perineal and laparoscopic approach: 12 years of experience in one center. Eur Urol 42: 104 –108, 2002. 11. Holzbeierlein JM, and Smith JA: Radical prostatectomy and collaborative care pathways. Semin Urol Oncol 18: 60 – 65, 2000. 12. Lepor H, Nieder AM, and Ferrandino MN: Intraoperative and postoperative complications of radical retropubic prostatectomy in a consecutive series of 1,000 cases. J Urol 166: 1729 –1733, 2001. 13. Lepor H, Nieder AM, and Fraiman MC: Early removal of urinary catheter after radical retropubic prostatectomy is both feasible and desirable. Urology 58: 425–429, 2001. 14. Goad JR, Eastham JA, Fitzgerald KB, et al: Radical retropubic prostatectomy: limited benefit of autologous blood donation. J Urol 154: 2103–2109, 1995. 15. Guillonneau B, Rozet F, Cathelineau X, et al: Perioperative complications of laparoscopic radical prostatectomy: the Montsouris 3-year experience. J Urol 167: 51–56, 2002. 16. Rassweiler J, Sentker L, Seemann O, et al: Laparoscopic radical prostatectomy with the Heilbronn technique: an analysis of the first 180 cases. J Urol 166: 2101–2108, 2001.
UROLOGY 61 (3), 2003
PROSPECTIVE COMPARISON OF SHORT-TERM CONVALESCENCE: LAPAROSCOPIC RADICAL PROSTATECTOMY VERSUS OPEN RADICAL RETROPUBIC PROSTATECTOMY SAM B. BHAYANI, CHRISTIAN P. PAVLOVICH, THOMAS S. HSU, WENDY SULLIVAN, LI-MING SU
AND
ABSTRACT Objectives. To evaluate and compare prospectively the convalescence of patients after laparoscopic radical prostatectomy (LRP) and open radical retropubic prostatectomy (RRP) in a standardized clinical care pathway at a single institution by two surgeons of equal experience and training. Methods. The study included all 60 patients undergoing LRP and RRP by two fellowship-trained surgeons in their first year of practice. The postoperative care of these patients was uniform and standardized. The medical records were reviewed and convalescence data obtained by an independent urologist and physician’s assistant. Results. Of the 60 patients, 24 underwent RRP and 36 underwent attempted LRP; 3 patients were converted from LRP to RRP. The differences in mean age, preoperative prostate-specific antigen level, Gleason score, in-hospital morphine equivalent requirement, time to oral intake, and hospital stay were not statistically significant between the LRP and RRP groups. The operating room time was significantly longer (5.8 ⫾ 1.2 hours versus 2.8 ⫾ 0.55 hours, P ⬍0.0001) and the estimated blood loss was significantly lower in the LRP group (533 ⫾ 212 mL versus 1473 ⫾ 768 mL, P ⬍0.0001) than in the RRP group. Pain medication use at home was significantly less in the LRP group (9 ⫾ 13 versus 17 ⫾ 15 oxycodone tablets, P ⬍0.04), as was the time to complete convalescence (30 ⫾ 18 days versus 47 ⫾ 21 days, P ⬍0.002). Conclusions. Although LRP took almost twice as long to complete as RRP in our initial clinical experience, the patients had a similar hospital course. LRP patients required less pain medication after discharge and had a shorter time to complete recovery than did RRP patients. Additional studies are needed to address long-term cancer control, potency, and continence outcomes to determine the precise role of LRP in the treatment of men with clinically localized prostate cancer. UROLOGY 61: 612–616, 2003. © 2003, Elsevier Science Inc.
T
he benefits of laparoscopy as a minimally invasive surgical technique have been well documented in urologic published reports. Patients undergoing laparoscopic nephrectomy, nephroureterectomy, and adrenalectomy have all enjoyed a shorter hospital stay, less postoperative pain, and improved cosmesis than patients undergoing open surgery.1–3 In addition, the reduction in the time of
From the James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore, Maryland Reprint requests: Li-Ming Su, M.D., Department of Urology, Section of Pelvic Laparoscopy and Stone Disease, Johns Hopkins Bayview Medical Center, 4940 Eastern Avenue, Room A345, Baltimore, MD 21224 Submitted: September 6, 2002, accepted (with revisions): October 25, 2002
612
© 2003, ELSEVIER SCIENCE INC. ALL RIGHTS RESERVED
convalescence has popularized these laparoscopic procedures. Radical prostatectomy remains the standard of care for the surgical treatment of patients with clinically localized prostate cancer. Laparoscopic radical prostatectomy (LRP) has recently emerged as an alternative technique to open radical retropubic prostatectomy (RRP); however, a critical comparison of convalescence after these two techniques has yet to be reported.4 – 6 The lower midline incision associated with open RRP is not as strikingly debilitating as the flank incision used for open nephrectomy or adrenalectomy. Therefore, the convalescence benefits of laparoscopic prostatectomy may not be as marked as those of laparoscopic nephrectomy or adrenalectomy. 0090-4295/03/$30.00 doi:10.1016/S0090-4295(02)02416-0
In this study, we prospectively compared the contemporaneous short-term convalescence of patients after open RRP and LRP using a standardized postoperative management protocol at a single institution with the operations performed by two surgeons with comparable years of experience and training. MATERIAL AND METHODS PATIENTS All patients undergoing RRP and LRP at Johns Hopkins Bayview Medical Center between July 2001 and June 2002 performed by two fellowship-trained surgeons (C.P.P. [urologic oncology fellowship with laparoscopic experience] and L.S. [laparoscopy/endourology fellowship]) in their first year of clinical practice were included in the study. Patients were counseled preoperatively on the risks and benefits of all options for treatment of prostate cancer, including both LRP and RRP. Patients who chose the open approach underwent a conventional RRP, as described by Walsh.7 Patients undergoing LRP underwent a transperitoneal operation, as described by Guillonneau and Vallancien.8
POSTOPERATIVE MANAGEMENT PROTOCOL The postoperative care was standardized for all patients according to the institutional clinical care pathway. All patients received a narcotic intravenous patient-controlled analgesia pump after surgery for management of their postoperative pain. Patients started taking a clear liquid diet on day 1 and advanced to a regular diet on day 2. All patients received a bisacodyl suppository on days 1 and 2 and were advised to ambulate with assistance starting on day 1. The method of pain control was converted to oral oxycodone when patients were tolerating a regular diet. All patients were discharged when tolerating a regular diet and ambulating independently. In the LRP group, a cystogram was routinely performed on day 7, and the Foley catheter was removed if no extravasation was present. If extravasation was present, a cystogram was repeated every 5 to 7 days until no extravasation was documented. In the RRP group, the catheter stayed in for 14 to 21 days depending on scheduling considerations.
DATA ACQUISITION The patient records were analyzed for clinical characteristics, operative information, and postoperative data. An independent urologist and a physician’s assistant, neither of whom had been involved in the patients’ care, obtained convalescence data. Partial convalescence was defined as the patient regaining independence and no longer requiring assistance from others with routine daily tasks. Full recovery was defined as the patient regaining complete physical strength with recovery to the preoperative state, including return to work, with the exceptions of urinary control and potency. Major complications were defined as those requiring a return to the operating room during the study period or prolonged hospitalization. Minor complications were those that were manageable in the office and/or had no clinical sequelae. No patients received postoperative radiation or hormonal therapy during the study period. Three patients who underwent conversion from the laparoscopic technique to an open procedure were excluded from analysis.
STATISTICAL ANALYSIS
The results are reported as the mean ⫾ standard deviation and were compared using the Student two-tailed t test. ComUROLOGY 61 (3), 2003
parisons were considered statistically significant with a P value of less than 0.05.
RESULTS Twenty-four patients underwent RRP and 36 underwent attempted LRP. Three patients in the LRP group were converted to RRP. The patient preoperative and operative characteristics are listed in Table I. The differences in mean age, preoperative prostate-specific antigen level, and Gleason score were not statistically significant between the LRP and RRP groups. The distribution of clinical and pathologic stages was similar between the two groups. Patients in the RRP group had a significantly shorter mean operative time of 2.8 ⫾ 0.55 hours versus 5.8 ⫾ 1.2 hours for the LRP group (P ⬍0.0001). The LRP patients had significantly less blood loss (533 ⫾ 212 mL versus 1473 ⫾ 768 mL) than the RRP patients (P ⬍0.0001). The postoperative data are summarized in Table II. No statistically significant differences were observed in the time to first oral intake, length of hospital stay, or morphine equivalent requirement during hospitalization. After discharge from the hospital, patients in the LRP group used significantly fewer oxycodone tablets (9 ⫾ 13 tablets versus 17 ⫾ 15 tablets, P ⬍0.04) and had a shorter time to partial convalescence (12 ⫾ 8 days versus 21 ⫾ 14 days, P ⬍0.004) and full recovery (30 ⫾ 18 days versus 47 ⫾ 21 days, P ⬍0.002) compared with patients in the RRP group. The LRP group also had a shorter catheterization time (14 ⫾ 6.9 days versus 19 ⫾ 1.2 days, P ⬍0.004). The incidence of both major and minor complications was comparable between the two groups. In the RRP group, 3 patients (12.5%) experienced bladder neck contractures requiring operative bladder neck incision (classified as major complications). In the LRP group, two major complications (6%) occurred. One patient developed left flank pain postoperatively and was found to have hydroureteronephrosis on intravenous urography with culmination of contrast to the ureterovesical junction. A nephrostomy tube was initially placed and later changed cystoscopically to a ureteral stent. Cystoscopy revealed edema at the left ureteral orifice from proximity to the urethrovesical anastomosis. After 1 month, the ureteral stent was removed, and a repeat intravenous urogram demonstrated complete resolution of the obstruction. The second major complication in the LRP group involved a dislodged Foley catheter requiring cystoscopic replacement on postoperative day 1. In the RRP group, two minor complications (8.3%) occurred. They were mild contractures of the bladder neck managed with dilation in the office, with no further sequelae. In the LRP group, 5 minor complications 613
TABLE I. Clinical, operative, and pathologic characteristics of patients Characteristic Mean age (yr) Mean PSA (ng/mL) Mean Gleason score on biopsy Race (n) AA H W Preoperative clinical stage (n) T1a T1c T2a T2b OR time (hr) EBL (mL) Final pathologic stage (n) T0 T2 T3a T3b
RRP (n ⴝ 24)
LRP (n ⴝ 33)
P Value
60.5 ⫾ 6.4 8.60 ⫾ 9.1 6.13 ⫾ 0.44
57.4 ⫾ 6.3 6.74 ⫾ 3.8 6.06 ⫾ 0.25
0.08 0.29 0.48 —
7 1 16
5 0 28
1 14 8 1 2.8 ⫾ 0.55 1473 ⫾ 768
0 21 11 1 5.8 ⫾ 1.2 533 ⫾ 212
1 14 6 3
0 26 6 1
—
⬍0.0001 ⬍0.0001 —
KEY: RRP ⫽ radical retropubic prostatectomy; LRP ⫽ laparoscopic radical prostatectomy; PSA ⫽ prostate-specific antigen; AA ⫽ African American; H ⫽ Hispanic; W ⫽ white; OR ⫽ operating room; EBL ⫽ estimated blood loss.
TABLE II. Convalescence and complications Time to first oral intake (days) Length of stay (days) Morphine equivalent requirement (mg) Major complications (n) Minor complications (n) Catheterization (days) Tablets of oxycodone used at home (n) Partial convalescence (days) Full recovery (days)
RRP (n ⴝ 24)
LRP (n ⴝ 33)
P Value
1⫾0 3.04 ⫾ 0.21 45 ⫾ 35 3 (12.5%) 2 (8.3%) 19 ⫾ 1.22 17 ⫾ 15 21 ⫾ 14 47 ⫾ 21
1.03 ⫾ 0.17 2.97 ⫾ 0.55 53 ⫾ 46 2 (6.1%) 5 (15.1%) 14 ⫾ 6.9 9 ⫾ 13 12 ⫾ 8 30 ⫾ 18
0.40 0.53 0.44 — — ⬍0.004 ⬍0.04 ⬍0.004 ⬍0.002
Abbreviations as in Table I.
(15.1%) developed, including calf myositis, obturator nerve palsy, postoperative hydrocele, epigastric artery injury, and inadvertent cystotomy; all were without sequelae. Three of 36 patients (8.3%) were converted from LRP to RRP. The reasons for conversion included hypercarbia in 1 patient, a suspected bladder injury in 1 patient that, after open conversion, was not found to be present, and a failure to progress during the posterior prostatic dissection owing to dense adhesions in 1 patient. None of these conversions was emergent or the result of a major surgical injury. COMMENT LRP is a relatively new technique for the surgical treatment of clinically localized prostate cancer 614
and has recently gained interest in Europe and the United States.4,9,10 Although LRP is a feasible procedure, its superiority over the open approach has not yet been demonstrated. The benefits of a shorter hospital stay, reduced postoperative pain, and shorter convalescence have been well demonstrated in comparisons between patients undergoing laparoscopic and open nephrectomy, nephroureterectomy, and adrenalectomy.1–3 To our knowledge, a critical assessment and comparison of short-term convalescence between RRP and LRP in the United States has not yet been published. Performing a comparative study of convalescence after RRP and LRP is difficult for two reasons. First, a comparison of the results after laparoscopic and open radical prostatectomy may be UROLOGY 61 (3), 2003
influenced by the experience of the surgeons involved. Although large series of open RRPs have been generated, it may not be valid to compare the latest results of an experienced open surgeon to that of a laparoscopist just beginning to perform LRP. As such, a prospective comparison of RRP and LRP performed by surgeons with a similar level of experience is desirable to assess the shortterm convalescence and outcomes accurately between the two groups. In the current study, comparisons were made between two surgeons who had both completed identical 6-year (2 years general surgery and 4 years urology) urology residencies and postgraduate fellowship training in urologic oncology (C.P.P.) and laparoscopy/endourology (L.S.). Furthermore, this study compared the early clinical experience of both surgeons in their first year of practice at a single institution. Second, comparisons between open RRP and LRP may be limited by differences in postoperative management. At our institution, highvolume prostate cancer surgery has allowed for the development of specific clinical pathways for the care of the radical prostatectomy patient. Such pathways have optimized and standardized postoperative care11 and were used in the care of both LRP and open RRP patients alike, thus limiting bias in perioperative care. In this standardized environment, no differences were found during hospitalization in terms of pain medication requirements, time to first oral intake, and length of hospitalization between the LRP and RRP patients. However, once discharged from the hospital, patients in the LRP group enjoyed significant advantages compared with the RRP group. Patients in the LRP group became independent of caregivers (12 versus 21 days) and achieved a complete recovery (30 versus 47 days) faster than did the RRP group. Additionally, the LRP group used less pain medicine at home than did the RRP group (9 versus 17 tablets). We were deliberately conservative in the treatment of both the LRP and the RRP patients. U.S. surgeons have shown shorter lengths of hospital stay after RRP and LRP.9,12 However, because this study reflected the early experience of both surgeons, patients were not encouraged to leave the hospital before postoperative day 3. The use of ketorolac, aggressive advancement of diet, and discharge to a local hotel could perhaps have shortened the hospitalization of both groups. However, it is unclear whether these changes influence the posthospital recovery time. Others have also advocated shorter periods of catheterization in both LRP and RRP.4,13 Again, because this was our initial experience, we were conservative and maintained catheterization for a mean of 14 days in the LRP group and 19 days in the RRP group. It is UROLOGY 61 (3), 2003
possible that a shorter length of catheterization could have influenced the convalescence of the LRP group. Several other factors could explain the different outcomes noted between the LRP and RRP groups in our study. Patients in the LRP group enjoyed significantly less blood loss than the RRP group. Investigators with more experience with the techniques have reported less blood loss in both LRP and RRP, and these changes could influence future outcomes.4,14 Another theoretical confounding factor could be that patients undergoing LRP may have expected a shorter convalescence because of the less invasive approach. Patients’ psychological expectations of the stress and pain associated with surgery may have influenced their perceived recovery time. Finally, patients who underwent LRP had a different geographic distribution than patients who underwent RRP. Only 20% of the LRP group lived in the Baltimore metropolitan area versus 75% of the RRP group. It is possible that if more LRP patients lived locally, they would have been more comfortable leaving the hospital earlier. Three patients underwent open conversion from LRP to RRP. Our conversion rate of 8.3% (3 of 36) is comparable to the initial experiences of other groups performing LRP.15,16 Because this study was designed to specifically address the convalescence of patients after LRP compared with RRP, we elected not to place these patients in either group, because they underwent transperitoneal laparoscopy followed by open radical prostatectomy. The postoperative course and convalescence for all 3 patients was similar to the open RRP cohort, and none of the patients had any long-term sequelae from their conversion. A comparison of our findings of improved convalescence after LRP with other published series is difficult, because no other series have been published from the United States. In one European series, patients stayed in the hospital until the Foley catheter was removed, which was a longer length of time after RRP than LRP (15 days versus 7 days).10 Comparison with the current series is also difficult because differences in healthcare delivery and cultural factors confound analysis. Radical prostatectomy is a technically challenging operation with a steep learning curve. Nevertheless, despite the significantly longer operative time for LRP in our initial experience, patients appear to benefit from less postoperative pain and an overall shorter convalescence compared with RRP. With more experience and with the use of ketorolac for postoperative pain, we are now routinely accomplishing LRP in 4 to 5 hours, discharging patients by postoperative day 2, and removing the urethral catheter by postoperative day 7. These changes are likely to translate to further benefits 615
for patients who select LRP as their surgical treatment of choice for prostate cancer, although comparable advantages may also be reached in the RRP group. Despite the advantages of improved convalescence, we contend that LRP must demonstrate comparable long-term cancer control, continence, and potency rates before it is fully accepted as an equivalent surgical technique to RRP. Additional long-term studies and larger series are necessary to support or refute this possibility. CONCLUSIONS Using a standardized postoperative clinical care protocol and comparing the results of two fellowship-trained surgeons in their early experience, LRP appears to offer patients significant advantages over RRP. These include a reduced pain medication requirement and a faster return to partial and full recovery, without an increased incidence of complications. Additional studies documenting long-term cancer control, continence, and potency are necessary to substantiate fully the role of LRP in the surgical treatment of patients with clinically localized prostate cancer. REFERENCES 1. Dunn MD, Portis AJ, Shalhav AL, et al: Laparoscopic versus open radical nephrectomy: a 9-year experience. J Urol 164: 1153–1159, 2000. 2. Shalhav AL, Dunn MD, Portis AJ, et al: Laparoscopic nephroureterectomy for upper tract transitional cell cancer: the Washington University experience. J Urol 163: 1100 –1104, 2000. 3. Gill IS: The case for laparoscopic adrenalectomy. J Urol 166: 429 –436, 2001.
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4. Guillonneau B, Cathelineau X, Doublet J, et al: Laparoscopic radical prostatectomy: assessment after 550 procedures. Crit Rev Oncol Hematol 43: 123–126, 2002. 5. Cadeddu JA, and Kavoussi LR: Laparoscopic radical prostatectomy: is it feasible and reasonable? Urol Clin North Am 28: 655–661, 2001. 6. Andriole GL: Laparoscopic radical prostatectomy: con. Urology 58: 506 –507, 2001. 7. Walsh PC: Anatomic radical retropubic prostatectomy, in Walsh PC, Retik AB, Vaughan ED, et al (Eds): Campbell’s Urology. Philadelphia, WB Saunders, 2002, vol 4, pp 3107– 3130. 8. Guillonneau B, and Vallancien G: Laparoscopic radical prostatectomy: the Montsouris technique. J Urol 163: 1643– 1649, 2000. 9. Menon M, Shrivastava A, Tewari A, et al: Laparoscopic and robot assisted radical prostatectomy: establishment of a structured program and preliminary analysis of outcomes. J Urol 168: 945–949, 2002. 10. Salomon L, Levrel O, de la Taille A, et al: Radical prostatectomy by the retropubic, perineal and laparoscopic approach: 12 years of experience in one center. Eur Urol 42: 104 –108, 2002. 11. Holzbeierlein JM, and Smith JA: Radical prostatectomy and collaborative care pathways. Semin Urol Oncol 18: 60 – 65, 2000. 12. Lepor H, Nieder AM, and Ferrandino MN: Intraoperative and postoperative complications of radical retropubic prostatectomy in a consecutive series of 1,000 cases. J Urol 166: 1729 –1733, 2001. 13. Lepor H, Nieder AM, and Fraiman MC: Early removal of urinary catheter after radical retropubic prostatectomy is both feasible and desirable. Urology 58: 425–429, 2001. 14. Goad JR, Eastham JA, Fitzgerald KB, et al: Radical retropubic prostatectomy: limited benefit of autologous blood donation. J Urol 154: 2103–2109, 1995. 15. Guillonneau B, Rozet F, Cathelineau X, et al: Perioperative complications of laparoscopic radical prostatectomy: the Montsouris 3-year experience. J Urol 167: 51–56, 2002. 16. Rassweiler J, Sentker L, Seemann O, et al: Laparoscopic radical prostatectomy with the Heilbronn technique: an analysis of the first 180 cases. J Urol 166: 2101–2108, 2001.
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