M. Baldarelli

A prospective randomized study with a 5-year minimum follow-up evaluation of transanal endoscopic microsurgery versus laparoscopic total mesorectal excision after neoadjuvant therapy.

BackgroundThis study aimed to compare the oncologic results for local excision via transanal endoscopic microsurgery (TEM) and those for laparoscopic resection (LR) via total mesorectal excision in the treatment of T2 N0, G1-2 rectal cancer after neoadjuvant therapy with both treatments, incorporating a 5-year minimum follow-up period.MethodsThe study enrolled 70 patients whose malignancy was staged at admission as T2 N0, G1-2 rectal cancer located within 6 cm of the anal verge with a tumor diameter less than 3 cm. Of these patients, 35 were randomized to TEM and 35 to LR. The patients in both groups previously had undergone high-dose radiotherapy (5,040 cGy in 28 fractions over 5 weeks) combined with continuous infusion of 5-flurouracil (200 mg/m2/day).ResultsThe median follow-up period was 84 months (range, 72–96 months). Two local recurrences (5.7%) were observed after TEM and 1 (2.8%) after LR. Distant metastases (2.8%) occurred in one case each after TEM and LR. The probability of survival for rectal cancer was 94% for TEM and 94% for LR.ConclusionsThe study shows similar results between the two treatments in terms of local recurrences, distant metastases, and probability of survival for rectal cancer.

Long‐term results in patients with T2–3 N0 distal rectal cancer undergoing radiotherapy before transanal endoscopic microsurgery

Local excision after radiotherapy for node‐negative low rectal cancer may be an alternative to radical excision. This study evaluated the results of local excision in patients with small (less than 3 cm in diameter) T2 and T3 distal rectal tumours following neoadjuvant therapy.

Transanal endoscopic versus total mesorectal laparoscopic resections of T2-N0 low rectal cancers after neoadjuvant treatment: a prospective randomized trial with a 3-years minimum follow-up period.

BackgroundThis study aimed to compare the results and the oncologic outcomes of transanal endoscopic microsurgery (TEM) with neoadjuvant radiochemotherapy and laparoscopic resection (LR), also with neoadjuvant radiochemotherapy, in the treatment of T2–N0 low rectal cancer.MethodsThe study enrolled 40 patients with T2–N0 rectal cancer, randomizing 20 to TEM (arm A) and 20 to LR (arm B).ResultsAfter neoadjuvant radiochemotherapy, tumor downstaging was observed for 13 patients (65%) in arm A (7 pT0 and 6 pT1) and in 11 patients (55%) in arm B (7 pT0 and 4 pT1). More than a 50% reduction of the tumor diameter was observed in four arm A cases and in six arm B cases. At a median follow-up period of 56 months (range, 44–67 months) in both arms, one local failure (5%) occurred after 6 months in arm A and one (5%) after 48 months in arm B. Distant metastases occurred in one arm A patient (5%) after 26 months of follow-up evaluation and in one arm B patient (5%) at 31 months. The probability of local or distant failure was 10% for TEM and 12% for laparoscopic resection, whereas the probability of survival was 95% for TEM and 83% for laparoscopic resection.ConclusionsThe findings show comparative results between the two study arms in terms of probability of failure and survival.

Hepatic resections by means of electrothermal bipolar vessel device (EBVS) LigaSure V: early experience

BackgroundMany techniques and devices are available for performing liver resection, such as clamp crushing, Cavitron Ultrasonic Surgical Aspirator (CUSA), Hydrojet and dissecting sealer, ultrasonic shears, and, more recently, electrothermal bipolar vessel sealing system (EBVS). In this prospective trial we sought to evaluate the impact of EBVS on hepatic resections.MethodsFrom March 2004 to December 2005, 24 patients from our consecutive liver resection series were enrolled in the present study. There were 17 males and 7 females with a mean age of 59.6 years (range = 41–80) who had colonic cancer metastases (18), hepatocarcinoma (3), angioma (2), and intrahepatic lithisasis (1). Patients were prospectively randomized to undergo liver resection via EBVS LigaSure V (12 patients, group A) or ultrasonic shears harmonic scalpel (HS) (12 patients, group B). Hepatic procedures did not differ significantly between the two groups and were as follows: right hepatectomy (2), left hepatectomy (1), bisegmentectomy (14), and segmentectomy (7).ResultsThere was no mortality in either group. The mean operative time was 136.7 min (range = 90–210) in group A and 187.9 min (range = 130–360) in group B. The Pringle maneuver was done in five patients in group A [mean time = 11.4 min (range = 6–12)] and in four patients in group B [mean time = 16 min (range = 9–26)]. The mean blood loss, total bile salts, and hemoglobin concentration from drained fluid on the second postoperative day were 205.8 vs. 506.7 ml, 0.6 vs. 1.1 mmol/L, and 1.0 vs. 2.1 g/L (p < 0.05) for groups A and B, respectively. Mean postoperative hospital stay was 6.1 vs. 7.8 days. In group B a patient who underwent right hepatectomy for colon cancer metastases had transient hepatic failure. No patients received blood transfusions in group A, while two or more blood units were administered in two cases in group B.ConclusionsIn the present study EBVS proved to be safe and effective for liver resection. By means of this device, statistically significant benefits concerning blood loss, total bile salts, and hemoglobin postoperative leakage were found.

Long-term results of laparoscopic versus open colorectal resections for cancer in 235 patients with a minimum follow-up of 5 years

BackgroundLaparoscopic resection for cure of colorectal cancer is controversial. More investigations on long-term results are required. This study aimed to compare the long-term outcome with a minimum follow-up of 5 years between laparoscopic or open approach for the treatment of colo-rectal cancer.MethodsThe treatment modality (laparoscopic or open) was related to the patients (pts) choice. The following parameters between the two groups (laparoscopic and open) were assessed: wound recurrences rate, local recurrences rate, incidence of distant metastases and survival probability analysis.ResultsWe report the long term outcome of 149 pts with colon cancer of which 85 treated by Laparoscopic Surgery (LS) and 64 by Open Surgery (OS) and of 86 patients with rectal cancer of which 52 treated by LS and 34 by OS. In the pts with colonic cancer, mean follow-up was 82.8 months. No Statistically Significant Difference (SSD) was observed in the local recurrences rate (3.5% after LS and 6.2% after OS) and in the incidence of distant metastases (10.5% after LS and 10.9% after OS). Cumulative survival probability in LS was 0.882 as compared to 0.859 after OS. In the pts with rectal cancer, mean follow-up was 78.5 months. No SSD was observed in the local recurrences rate (19.2% after LS and 17.6% after OS) and in the incidence of distant metastases (15.3% after LS and 20.5% after OS). Cumulative survival probability in LS was 0.711 as compared to 0.617 after OS. We report an interesting data about the time of recurrences between LS and OS: the recurrences were delayed after LS, both after colonic (22.6 months vs 6.5) and rectal (25.7 months vs 13.0) resections, respectively.ConclusionWe suppose that laparoscopic surgery in the treatment of colo-rectal cancer is quite safe. However, further investigation is needed.

The learning curve in laparoscopic adrenalectomy.

Background: Laparoscopic adrenalectomy (LA) is the procedure of choice for surgical management of most adrenal tumors. LA learning curve (LC) varies among surgeons and may be influenced by factors depending on surgeon, patient, and lesion peculiarities. The aim of this study was to evaluate the LC by multi-dimensional analysis. Methods: Between August 1994 and August 2005, 241 LA were performed in our department. Data were prospectively collected. The pre-operative variables evaluated were patient-related (age, gender, body mass index, co-morbidities) and disease-related (histology, size, and side of lesion). Level of experience of surgical team and surgical approach (anterior, flank, submesocolic routes) were evaluated as well. Flank approached and bilateral procedures were excluded, while submesocolic LA, were collected separately. Operating time (OpT), conversion rate (CR), intra-operative and post-operative complications were evaluated. Patient, surgeon, and procedure-related factors involved in LC were investigated by a multi-factorial logistic regression analysis. Results: Body mass index, side, size, histology, technology improvement, and experience of surgical team, evaluated through the progressive series of surgical procedures, were independent predictors of CR and OpT. The CR for right adrenalectomy was 3% (3 cases) compared to 4.2% for left side (6 cases). The submesocolic approach significantly influenced OpT, but not CR. Mean OpT for right and left LA was 83 and 109 min, respectively. Based on surgical experience increase, the OpT and CR flattened their curves, roughly at 30 and 40 procedures for right and left LA, respectively. Post-operative complications did not change considerably throughout the series. Readmission rate within 30 days was negligible. Conclusions: Manifold factors may affect LC and outcome in LA. Their knowledge may support teaching activities as well as reducing conversion and complication rates.

Treatment of rectal cancer by transanal endoscopic microsurgery: experience with 425 patients.

AIM To describe our experience in treating rectal cancer by transanal endoscopic microsurgery (TEM), report morbidity and mortality and oncological outcome. METHODS A total of 425 patients with rectal cancer (120 T1, 185 T2, 120 T3 lesions) were staged by digital rectal examination, rectoscopy, transanal endosonography, magnetic resonance imaging and/or computed tomography. Patients with T1-N0 lesions and favourable histological features underwent TEM immediately. Patients with preoperative stage T2-T3-N0 underwent preoperative high-dose radiotherapy; from 1997 those aged less than 70 years and in good general health also underwent preoperative chemotherapy. Patients with T2-T3-N0 lesions were restaged 30 d after radiotherapy and were then operated on 40-50 d after neoadjuvant therapy. The instrumentation designed by Buess was used for all procedures. RESULTS There were neither perioperative mortality nor intraoperative complications. Conversion to other surgical procedures was never required. Major complications (urethral lesions, perianal or retroperitoneal phlegmon and rectovaginal fistula) occurred in six (1.4%) patients and minor complications (partial suture line dehiscence, stool incontinence and rectal haemorrhage) in 42 (9.9%). Postoperative pain was minimal. Definitive histological examination of the 425 malignant lesions showed 80 (18.8%) pT0, 153 (36%) pT1, 151 (35.5%) pT2, and 41 (9.6%) pT3 lesions. Eighteen (4.2%) patients (ten pT2 and eight pT3) had a local recurrence and 16 (3.8%) had distant metastasis. Cancer-specific survival rates at the end of follow-up were 100% for pT1 patients (253 mo), 93% for pT2 patients (255 mo) and 89% for pT3 patients (239 mo). CONCLUSION TEM is a safe and effective procedure to treat rectal cancer in selected patients without evidence of nodal involvement. T2-T3 lesions require preoperative neoadjuvant therapy.

Laparoscopic adrenalectomy in pheochromocytomas

Background: The aim of this study was to evaluate 17 patients undergoing laparoscopic adrenalectomy for the treatment of pheochromocytoma by transperitoneal anterior approach. Methods: Seventeen patients underwent laparoscopic adrenalectomy for pheochromocytoma between January 1994 and May 2002. Ten females (58.8%) and 7 males (41.2%) were operated on; 14 patients (82.3%) had sporadic pheochromocytoma and 3 (17.7%) were familiar cases. Mean age was 42 yr (range 25–72 yr). All patients were treated pre-operatively with α-blockers. Seven patients (41.2%) underwent right adrenalectomy; 9 (52.9%) underwent left adrenalectomy and 1 (5.9%) bilateral adrenalectomy. Results: No conversion to open surgery occurred and no mortality was observed. The right-side adrenalectomy required a mean operative time of 86 min (range 45–120), the left-side procedure a mean operative time of 116 min (range 80–140) and the bilateral one 219 min. In two patients (11.8%), a laparoscopic cholecystectomy and ovariectomy, respectively, were performed without changing the position of the patient on the operating table. Only 1 patient (5.9%) presented significant intraoperative hypertension, and arrhythmia resolved by medical therapy. No other intraoperative and post-operative complications were reported. Mean hospital stay was 3 days (range 2–8 days). At mean follow-up of 48 months (range 6–96 months), regression of symptoms and control of blood pressure were obtained without additional treatment in all patients. No recurrences were reported. Conclusion: In our experience, adrenal pheochromocytoma can be treated safely and effectively by laparoscopic transperitoneal anterior approach.

Use of the electrothermal bipolar vessel system (EBVS) in laparoscopic adrenalectomy: a prospective study

BackgroundSince laparoscopic adrenalectomy (LA) has been adopted as the gold standard for the treatment of adrenal diseases, the development of technology for vascular control and dissection manoeuvres, amongst other things, may play a pivotal role in its further improvement. We report our experience with the electrothermal bipolar vessel sealing (EBVS) device for LA.MethodsFrom January 2004 to January 2006, 50 patients (pts) undergoing LA were selected and randomized for use of the EBVS (25 pts, group A) versus the UltraSonic Shears (USS) device (25 pts, group B). Age, sex, body mass index (BMI), previous surgery and associated diseases were similar between the two groups. The main surgical parameters collected for each patient (pt) concerned operative time, major and minor complications, conversion rate, blood loss, hospital stay and histology.ResultsThere was no mortality in either group. The right adrenalectomy mean operative time (OpT) was 51.8 mins (range 40–90 mins) and 68.6 mins (range 50–130 mins) in group A and B, respectively (P not significant). The left adrenalectomy mean OpT was 72.2 mins (range 55–100 mins) and 94 mins (range 65–140 mins) for group A and B, respectively (P < 0.05). The mean blood loss was 83 ml (group A) and 210 ml (group B) (p < 0.05). Complications were not different for the two groups. The mean hospital stay was 2.9 and 3.1 days in group A and B, respectively (P not significant).ConclusionsEBVS in LA may provide a significantly short operating time and blood loss.

Early Rectal Cancer: Definition and Management

Background: Local excision of rectal cancer is an alternative to radical resection but today its role surrounding the management of patients with early stage rectal cancer (T1-T2-N0) represents an important surgical issue. Aim: To analyze the results of 135 patients with early stage low rectal cancer treated with local excision by transanal endoscopic microsurgery and in the case of T2 also by neoadjuvant therapy. Study Design:135 patients with T1-T2-N0-M0 rectal cancer were enrolled in the study. Staging according to the definitive histological findings was as follows: pT0 in 24 patients (17.8%), pT1 in 66 patients (48.8%) and pT2 in 45 patients (33.4%). Results: Minor complications were observed in 12 patients (8.8%) whereas major complications were seen only in 2 patients (1.5%). At a median follow-up of 78 (36–125) months, local recurrences occurred in 4 patients and distal metastasis in 2 patients (all patients were staged preoperatively T2). Disease-free survival rates in T1 and T2 patients were 100 and 93% respectively at the end of follow-up. Conclusions: With respect to local recurrence and survival rate, the long-term results of early stage rectal cancer in patients treated with transanal endoscopic microsurgery were similar to those reported in the literature after conventional surgery (total mesorectal excision).