Guidelines for urological laparoscopic surgery

In recent years, minimally invasive laparoscopic surgical techniques have been developed in the various specialties, and applied to ever increasing patient numbers. Serious complications do occur sometimes, however, constituting a major social problem. This has created an urgent need for standardized indications for laparoscopic surgery, based on high-quality evidence, which will allow patients to undergo surgery with confidence. With this social background in mind, in April 2008 the Japanese Society of Endourology and ESWL published therapeutic guidelines for six representative laparoscopic procedures in the urological field, including laparoscopic adrenalectomy, laparoscopic radical nephrectomy, laparoscopic nephroureterectomy, laparoscopic radical prostatectomy, laparoscopic donor nephrectomy and laparoscopic pyeloplasty. These guidelines aim to provide information, conforming to the principles of evidence-based medicine, related to indications, diagnosis and surgical techniques, with the aim of improving clinical skill levels. These guidelines are intended to offer information about urological laparoscopic procedures to general medical practitioners and specialists, as well as patients and their families. In this paper, we present an overview of the guidelines for six urological laparoscopic procedures. For the literature search in formulating these guidelines, we used PubMed for English language publications, and Japana Centra Revuo Medicina for Japanese language publications. Keyword-based searches were performed on 10 May 2005, with no restrictions on the date of publication. The final numbers of adopted references with structured abstracts were 82 for laparoscopic adrenalectomy, 41 for laparoscopic radical nephrectomy, 42 for laparoscopic nephroureterectomy, 132 for laparoscopic radical prostatectomy, 56 for laparoscopic donor nephrectomy, and 34 for laparoscopic pyeloplasty: a total of 387. The evidence level for these references was graded I to VI, and the number of references with structured abstracts at each evidence level quoted in these guidelines is shown in Table 1. Grades of recommendation are based on overall consideration of factors including the level of evidence in the reference material. However, the literature contains very little high-level evidence, such as large-scale randomized controlled trials, related to each laparoscopic procedure, so we have not given grades of recommendation, but rather stated the level of evidence for each reference source in the reference section. In this paper, we will only quote representative sources. The indications for laparoscopic adrenalectomy are functional benign tumors, such as primary aldosteronism, Cushing's syndrome, and pheochromocytoma, and non-functioning benign tumors, such as ganglioneuroma, non-functioning adenoma, myelolipoma, and cyst.1-3 In general, laparoscopic resection for pheochromocytoma is considered difficult, but there should be no problems with safety in the hands of an experienced surgeon with careful preoperative and intraoperative management, including blood pressure control. Laparoscopic surgery for malignant adrenal tumors was contraindicated, due to the high risk of peritoneal dissemination, port site recurrence, and local recurrence.4 Recent studies have shown, however, that relatively small solitary adrenal metastases (e.g. lung, renal and colorectal cancer) rarely invade beyond the adrenal capsule, and results with laparoscopic resection are comparable to those with open procedures in terms of positive surgical margin rates and survival rates.4, 5 Debate continues over the application of laparoscopic adrenalectomy for primary adrenocortical cancer, and further study will be required before a consensus can be reached.4, 5 An open procedure is indicated in cases of malignancies with local invasion, multiple systemic metastases, or a surgical history of the local site.4 The initial indication for laparoscopic adrenalectomy was a benign tumor less than 5–6 cm in diameter. The indications have more recently expanded to include tumors greater than 5–6 cm in size.6 A number of reports have suggested an upper limit of 10–12 cm due to the technical demands and the increased possibility of malignancy.6 There are four possible laparoscopic approaches to the adrenal glands, each with its advantages and disadvantages. Selection of the approach to be used depends on the experience of the surgeon, but in general less experienced surgeons should take a transperitoneal approach, providing greater space and allowing observation of the organs as familiar anatomical landmarks within the abdominal cavity.7 For adrenal tumors up to 5–6 cm in diameter, an anterior transperitoneal approach is recommended for right-sided lesions, and a lateral transperitoneal approach for left-sided lesions. When the size of the tumor exceeds 5–6 cm, the transperitoneal lateral approach is recommended for both left and right tumors. In addition, a transperitoneal approach, facilitating recognition of landmarks, is recommended for obese patients, and a retroperitoneal approach for patients with a history of abdominal surgery, in whom adhesions can be anticipated.7 There is considerable debate over surgical resection for incidentally discovered adrenal tumor (incidentaloma). The National Institute of Health (NIH) State-of-the-Science Statement regarding adrenal incidentalomas states that surgical resection is indicated for functional tumors and non-functioning tumors greater than 6 cm in diameter.8 Observation only is recommended for non-functioning tumors smaller than 4 cm. Surgical resection is strongly recommended for non-functioning tumors of 4–6 cm in size that show a rapid increase in size, with radiological findings that tend to exclude adenoma, such as a low lipid content. The choice of laparoscopic or open surgery depends on the possibility of invasive adrenocortical cancer, technical considerations, and the experience of the surgical team. The collated results of reports of laparoscopic adrenalectomy for various adrenal tumors, with series of at least 50 patients each, showed that most studies reported a mean operative time of 1.5–3 h, mean blood loss of 30–100 mL, mean hospital stay of 2–6 days, and conversion to an open procedure in 0–5% of cases.3, 9-11 A systematic review of reports of laparoscopic adrenalectomy with series of at least 40 patients each yielded a complication rate, including intraoperative and postoperative complications, of approximately 10% of the total 2550 cases.3 The most common intraoperative complication was hemorrhage, accounting for 18.5% of the total. The blood transfusion rate was low at 2.1%, however. Organ injuries accounted for 4.2% of intraoperative complications; the organs damaged included the liver, spleen, pancreas, kidney, bowel and diaphragm. Hemorrhage was also the most common postoperative complication, accounting for 21.5% of the total. This was followed by wound complications (hematoma, infection, etc.), urinary tract infection and thromboembolism. The reported mortality rate is 0.2%. According to the national survey conducted by the Japan Society for Endoscopy Surgery, 4909 laparoscopic adrenalectomies were performed in Japan between 1992 and 2005.1 Of these, 159 (3.2%) were converted to an open procedure. Intraoperative complications were reported in 232 cases (4.7%), including hemorrhage (cases requiring conversion to an open procedure to achieve hemostasis), visceral injuries and CO2 embolism. Postoperative complications were reported in 142 cases (2.9%), including wound infection, hemorrhage, respiratory complications and peritonitis. Postoperative laparotomy for complications was required in 21 cases (0.4%). There was one surgery-related death (0.02%). We analyzed reports of laparoscopic procedures with series of at least 20 patients.10, 12-14 Many studies have reported a significantly longer operative time for laparoscopic than open procedures, although the operative time can be reduced with the learning curve effect. Many studies have reported significantly less blood loss, and a lower rate of complications, for laparoscopic procedures. Significantly lower postoperative analgesia requirements, and significantly faster recovery, are also reported for laparoscopic than open procedures. There are, at present, few high-level evidence studies of the invasiveness of laparoscopic surgery, but laparoscopic procedures are less invasive than open procedures. Laparoscopic partial adrenalectomy is performed with the aim of preserving adrenal function.15 However, as a result of investigating all resected tissue specimens of the adrenal gland, multiple nodules were seen in approximately 10% of cases,16 and in particular in cases of primary aldosteronism, multiple nodules were present in 20% or 25% of specimens.16, 17 A case of persistent hypertension and elevated plasma aldosterone levels following partial adrenalectomy, thought to be due to undetected micronodules in the ipsilateral adrenal gland, has been reported.17 The indication for laparoscopic partial adrenalectomy should therefore be considered carefully in light of the risk of incomplete resection and recurrence. Although there is, at present, a lack of high-level supportive evidence, laparoscopic adrenalectomy is less invasive than open surgery. Many studies report a significantly longer operative time for laparoscopic adrenalectomy than for the open procedure, but these can be reduced with the learning curve effect. From the above, laparoscopic adrenalectomy is a standard technique, and should become the treatment of first choice, for benign adrenal tumors less than 5–6 cm in size. Further studies are needed to determine the indications for laparoscopic adrenalectomy for malignant lesions, in particular primary adrenocortical cancers. Laparoscopic radical nephrectomy for renal cell carcinoma is a procedure in which the renal vessels are dissected without disturbing the tumor, and the kidney is dissected as a single mass with the adrenal gland and perirenal fat enclosed in the renal fascia, under laparoscopic control.18, 19 Laparoscopic radical nephrectomy can be performed using a transperitoneal or retroperitoneal approach; the procedure can be conventional18-31 or hand-assisted laparoscopic surgery (HALS).32-34 The resected kidney is extracted from the abdominal cavity by placing it in a retrieval bag and either removed intact or made smaller by fractionation, and withdrawn through the appropriately sized incision. The position of laparoscopic incisions can be changed, reducing postoperative pain and exercise impairment.19, 22, 23, 27 A number of studies recommend laparoscopic radical nephrectomy for stage I localized renal cell carcinoma, as there are no differences between open and laparoscopic procedures in terms of antitumor effect as measured by disease-free survival rates or overall survival rates. Furthermore, laparoscopic procedures are associated with fewer intraoperative and postoperative complications, a lower analgesic requirement, and shorter postoperative hospital stays.20-23, 25, 29, 31 However, laparoscopic procedures can sometimes be extremely difficult technically due to the tumor size or position. Some institutions have reported surgical results comparable to those achieved with open surgery for laparoscopic resection of Stage II renal tumors and metastatic renal tumors. There have also been reports of successful laparoscopic treatment of tumor emboli of the renal veins, and T4 renal tumors, so further studies are required with increased patient numbers to determine long-term outcomes.24, 26, 28 Laparoscopic surgery for renal cell carcinoma is no longer confined to Stage I and II localized disease, but has recently become one of the standard treatments for renal cell carcinoma, performed in Stage III cases with renal vein tumor emboli, and as cytoreductive surgery for resection of the primary tumor in Stage IV disease with distant metastases.24, 26, 28 For localized renal cell carcinoma, operative times of 3–6 h and 100–300 mL blood loss have been reported, indicating longer operative times than open procedures but less blood loss.20-23, 32, 33 Conversion to an open procedure, due to hemorrhage or visceral injury, is reported in 3–8% of laparoscopic procedures.21, 22, 33 The incidence of complications associated with laparoscopic nephrectomy varies according to the inclusion criteria for complications adopted by each investigator, and is generally reported as similar to, or slightly higher than, open surgery.20-22, 29, 33 According to a national survey, 4878 laparoscopic radical nephrectomies were performed in Japan between 1992 and 2005, 3935 pure laparoscopic procedures and 913 HALS. There were three deaths (0.06%).1 A major difference between laparoscopic and open surgery is that the incisions are extremely small in the former. Minimal invasiveness is the greatest advantage of laparoscopic radical nephrectomy, accounting for the explosive growth in patient numbers undergoing this procedure worldwide. The mean hospital stay for laparoscopic procedures is 4.8 days, considerably shorter than that of 8.4 days for open procedures, and the return to normal activity 3.2 weeks after a laparoscopic procedure is also significantly shorter than that of 7.4 weeks after an open procedure. Analgesia requirements following laparoscopic surgery are between 1/7 and 1/2 of those following open surgery.19-25, 32 If the proper procedures are followed (e.g. placing the resected kidney in a retrieval bag), port site recurrence, a characteristic complication of laparoscopic surgery where dissemination or metastasis of cancer is seen at the instrument ports, is rarely seen. The incidence of local recurrence is similar to that seen with open surgery.26, 27, 29, 30, 34 A study comparing the long-term anticancer effect in patients with cT1 or 2N0M0 renal cell carcinoma, in 64 patients who underwent laparoscopic radical nephrectomy and 69 patients who underwent open radical nephrectomy, found that that the 5-year disease-free survival rate was 92% for the former and 91% for the latter. The 5-year overall survival rates were 81% and 89%, respectively, so the authors concluded that there was no difference between the anticancer effect of the two procedures.29 A subsequent comparative study also reported a 5-year disease-free survival rate of 91% and a 5-year cancer-specific survival rate of 94% for patients following laparoscopic radical nephrectomy for Stage I renal cell carcinoma, and no significant difference to the respective rates of 87% and 94% following open radical nephrectomy. Similarly, no difference in anticancer effect has been seen between laparoscopic and open radical nephrectomy in the anticancer effect for patients with Stage II renal cell carcinoma.21, 23, 28, 31 Patient numbers are small for laparoscopic radical nephrectomy for Stage III and IV advanced disease, and further studies are needed. Follow up for 2–3 years has revealed no difference in overall survival rates between laparoscopic cytoreductive surgery for primary renal cell carcinoma in patients with metastatic disease and open procedures.24, 26, 28 Although there are, at present, no high-level supportive studies, laparoscopic radical nephrectomy is considered less invasive than open surgery, and although operative times are longer, blood loss is reduced. A number of reports have found the anticancer effect to be similar for laparoscopic and open procedures in patients with localized renal cell carcinoma, and laparoscopic radical nephrectomy is considered the standard treatment for Stage I disease. The choice of technique in patients with Stage II disease depends on whether laparoscopic resection is technically feasible. Further studies are needed to address the question of the indications for laparoscopic surgery for advanced Stage III and IV renal cell carcinoma, due to the high degree of technical difficulty and the dearth of reports of long-term results. In addition, we will address the question of surgical resection of lymph nodes and adrenal glands in the treatment of renal cell carcinoma. Studies finding no merit in lymph node dissection have led to radical nephrectomy being widely performed without lymph node dissection, even in open procedures, and this has increasingly become the standard treatment. Adrenal-sparing radical nephrectomy and partial nephrectomy for smaller cancers, are also being performed, and the definition of radical nephrectomy itself is changing. These guidelines have concentrated on the technical aspects of laparoscopic radical nephrectomy for renal cell carcinoma, and we plan to leave the discussion of whether lymph nodes or adrenal glands should be resected at the time of radical nephrectomy to another time, and abide by the conclusions reached at that time. From the results of a number of retrospective descriptive studies, laparoscopic nephroureterectomy is indicated in patients with upper tract urothelial carcinoma up to clinical stage T2, with no evidence of lymph node metastases. No conclusions can be made about patients with stage T3 disease due to the lack of comparative trials stratified for clinical stage. Laparoscopic surgery is not contraindicated in patients with stage T3–4 disease, as a similar anticancer effect to open surgery has been demonstrated in studies including this patient group. Laparoscopic-assisted nephroureterectomy is indicated in patients with advanced ureteric carcinoma, where nephrectomy is performed laparoscopically, and resection of ureteric tumor as an open procedure. There have been few reports of laparoscopic nephroureterectomy in patients with tumor invasion of adjacent organs, or widespread lymph node metastases, and further studies are needed in this area. Only a limited number of studies have addressed the question of the indications, appropriate range and techniques for lymph node dissection in association with laparoscopic nephroureterectomy. The collated results of reports of laparoscopic nephroureterectomy for upper tract urothelial tumors, with series of at least 20 patients each, showed that most studies reported a mean operative duration of 4–6 h for laparoscopic, laparoscopic-assisted and hand-assisted procedures alike. The average blood loss was 200–500 mL, the mean hospital stay 4–10 days, and conversion to an open procedure occurred in 0–10% of cases.35-45 In another study, five out of 116 patients (4%) at five institutions were converted to an open procedure.46 A review of reports of laparoscopic nephroureterectomy, collating results for 377 patients, yielded a mean operative duration of 276.6 min, a blood loss of 240.9 mL, a minor complication rate of 12.9%, and a major complication rate of 5.6%.36 According to a national survey, 2435 laparoscopic nephroureterectomies were performed in Japan between 1992 and 2005, 1960 laparoscopic procedures and 913 HALS. There were two surgery-related deaths (0.08%).1 We were unable to identify any randomized controlled trials that compared laparoscopic and open procedures. Most reports were of descriptive studies with case series, so we examined reports of laparoscopic nephroureterectomy series with at least 10 patients.35-41, 47-50 We found one case–control study. A review article that collated results for 377 patients found that although operative times are longer, blood loss is reduced for laparoscopic nephroureterectomy. A case–control study of 11 HALS patients and 11 patients who underwent open surgery matched for age, gender and American Society of Anesthesiologists (ASA) classification found no difference in operative times, and significantly less blood loss in the HALS group.49 Many descriptive studies have also found no difference in operative times between laparoscopic nephroureterectomy (including HALS) and open surgery,37, 38, 48 although some have reported laparoscopic surgery takes longer,39, 40, 50 and some have even found laparoscopic surgery to be shorter.35 The majority of studies have found intraoperative blood loss to be less with laparoscopic than open surgery.35, 38-40, 47, 48 From the above, we conclude that operative times are the same or slightly longer, and blood loss is less with the laparoscopic procedure compared to open surgery. A review of 15 laparoscopic nephroureterectomy series (total 312 patients) and 11 open nephroureterectomy series (total 206 patients) revealed a major complication rate of 0–19% (mean 5.6%) for laparoscopic surgery, and 0–29% (mean 8.3%) for open surgery. The minor complication rate was 0–40% (mean 12.9%) for laparoscopic surgery, and 0–45% (mean 14.1%) for open surgery. No difference was seen between procedures.36 Other descriptive studies also reported no difference in the rate of complications between laparoscopic and open surgery.35, 37-39 Complications specific to laparoscopic nephroureterectomy were leakage of large volumes of irrigation fluid during transvesical dissection of the distal ureter,35 urinary leakage from the stapled vesical closure site,39 and port-site hernia.45 The above-mentioned case–control study of 11 HALS patients and 11 open surgery patients found that the duration of extradural anesthesia and hospital stays were significantly shorter in the former group.49 Other studies found that laparoscopic surgery was superior to open surgery in terms of the time until patients walked postoperatively,35, 38 the time until resuming eating,35, 38, 40, 47, 48, 50 postoperative analgesia requirement,35, 38-40, 48 hospital stay,35, 38, 40, 47, 48, 50 and postoperative recovery time.35, 38-40, 47, 50 No studies reported superiority for open surgery. Although our search revealed no prospective randomized controlled trials, postoperative recovery tends to be faster following laparoscopic than open nephroureterectomy. A study examining the effects of surgery on body shape using computed tomography scanning, found that there was less distortion of body shape following laparoscopic nephroureterectomy, which does not leave a large upper abdominal wound, than an open procedure.51 Studies of postoperative anticancer effect of laparoscopic nephroureterectomy, with series of at least 20 patients, reported vesical recurrence in 4.5–55.5% of cases,35, 36, 39-46, 52 distant metastases in 0–28%,35, 36, 39-46 local recurrence in 0–15%,36, 39-41, 43, 45, 46 2-year cancer-specific survival rates of 77–94%,39, 46 a 5-year cancer-specific survival rate of 81%,36 and a 5-year metastasis-free survival rate of 72%.41 A review of studies published between 1991 and 2004 that compared laparoscopic nephroureterectomy (including HALS) and open surgery found that the average postoperative vesical recurrence rate was 24.0% for the former and 24.7% for the latter, local recurrence rates were 4.4% and 6.3%, respectively, and the rates of distant metastasis were 15.5% and 15.2%. The average 2-year cancer-specific survival rates were 75.2% and 76.2%, and the 5 year overall survival rates were 81.2% and 61%, respectively.36 A study that compared outcomes following laparoscopic and open surgery over a 7-year follow-up period found no differences in rates of local recurrence, vesical recurrence, or 1- and 5-year metastasis-free survival rates.41 Other descriptive studies have also reported no differences in positive surgical margin rates,35 postoperative vesical recurrence rates,40 or local recurrence rates.40 The proportion of patients with Stage pT3 tumors in these studies was 12–35% in the laparoscopic and in the open with no difference between in most There have been no studies that report significantly higher recurrence or lower survival with laparoscopic nephroureterectomy than with open surgery. The lack of studies with follow-up greater than 5 years it to any however. recurrence is a with laparoscopic procedures that and small There have been reported some thought to be by of a through a small without using a retrieval and some cases of port-site metastasis to tissue 42 recurrence is more common in patients with malignant disease. When laparoscopic surgery for upper tract urothelial cancer, to tumor dissemination and port-site recurrence, it is that the tumor and should not be and that the resected is in a retrieval bag before from the body a is not Although there are, at present, no prospective controlled trials, laparoscopic nephroureterectomy is considered less invasive than open surgery. Some studies have reported that operative times are longer than with open procedures, although with techniques laparoscopic procedures can become similar in duration or even A number of studies have found the anticancer effect to be similar for laparoscopic and open nephroureterectomy, but the follow-up it to any recurrence has been reported with tumors, requiring From the above, laparoscopic nephroureterectomy is a minimally invasive procedure for upper tract urothelial The question of the indications for laparoscopic surgery for advanced cancer further study. The technique for of the distal should be according to the tumor site and so as to cancer cell dissemination, and resection should include the Laparoscopic lymph node dissection should be performed in the same as an open procedure. for laparoscopic radical is localized therapeutic results are with a level and disease, so these are considered the the or localized T3 disease are not for laparoscopic radical but consideration should be given to and of in treatment The collated results of reports of laparoscopic radical prostatectomy, with single series of at least patients each, showed a mean operative time of h, average blood loss of mL, average time of days, blood transfusion rate of and conversion to open procedure in of A systematic review of laparoscopic radical found an intraoperative complication rate of with complications further surgery in of complications included hemorrhage and to the urinary tract or blood vessels or a complication, occurred in of laparoscopic as with open procedures, discovered during the primary Complications are more common with so as their the of complications can be A Japanese survey collated the results for laparoscopic radical finding that 28 were converted to an open The intraoperative complications were in 28 cases vesical in 15 in 11 and ureteric in three Further surgery was required in three cases and blood transfusion in We were unable to identify any randomized controlled trials that compared laparoscopic radical and open surgery, radical Most reports were controlled and our search also found two systematic of the controlled results that operative times are longer, but blood loss is reduced and transfusion required less with laparoscopic radical in to radical The incidence of intraoperative complications was for laparoscopic procedures, and for open procedures, with no difference found between A study that compared postoperative pain levels using a pain found that on the first postoperative pain was significantly less in the laparoscopic surgery than in the open surgery Most studies found hospital stays were shorter following laparoscopic In the experience of laparoscopic radical urinary leakage from the was and times were similar to those after an open times can be reduced as become more in laparoscopic surgery, and the prospective study of reducing times conducted by reported that be removed at days in out of patients A systematic review of the published reports up until found that the proportion of patients urinary at were for laparoscopic surgery, and for open surgery, with no difference seen between The proportion of patients was for laparoscopic surgery, and for open surgery, with no difference seen between The Japanese survey of postoperative by found that patients who