A modified sentinel lymph node technique combined with endoluminal loco-regional resection for the treatment of rectal tumours: a 14-year experience.

AIM: After endoluminal loco-regional resection (ELRR) by transanal endoscopic microsurgey (TEM) the N parameter may remain undefined. Nucleotide-guided mesorectal excision (NGME) improves the lymph node harvest. The aim of the present study is to evaluate the long-term oncological results after ELRR with NGME. METHOD: A total of 57 patients were enrolled over the period January 2001 to June 2015. All patients underwent ELRR by TEM. Prior to surgery, 99 m-technetium-marked nanocolloid was injected into the peritumoural submucosa. After removal of the specimen, the residual defect was probed to detect any residual radioactivity and 'hot' mesorectal fat was excised. All patients were included in a 5-year follow-up programme. RESULTS: Significant radioactivity in the residual cavity was found in 28 out of 57 patients (49%). The mean number of lymph nodes harvest in irradiated and nonirradiated patients was 1.66 and 2.76, respectively. After 68.2 months' follow-up overall survival was 91.2%, disease-related mortality 3.5% and disease-free survival 89.5%. Two patients developed pulmonary metastases: one ypT3N0 patient underwent lung lobectomy after chemotherapy and one pT2N0 patient was managed with lung radiotherapy. Both patients are currently alive and disease-free at 48 months' follow-up. Two patients developed local recurrence 1 year after ELRR, both treated with neoadjuvant chemo-radiotherapy and total mesorectal excision. Comparing the present series with previous patients who did not undergo NGME, an increased number of harvested lymph nodes were observed, with a statistically significant difference (P = 0.0085). CONCLUSION: NGME during ELRR improves the lymph node harvest and staging accuracy. The long-term results showed satisfactory local (3.5%) and distant (7%) recurrence rates.

Anal function after endoluminal locoregional resection by transanal endoscopic microsurgery and radiotherapy for rectal cancer.

AIM: In patients with rectal cancer, surgery and chemoradiotherapy may affect anal sphincter function. Few studies have evaluated anorectal function after neoadjuvant chemoradiotherapy (n-CRT) and/or transanal endoscopic microsurgery (TEM). The aim of this study was to evaluate the effects of n-CRT and TEM on anorectal function. METHOD: Thirty-seven patients with rectal cancer underwent anorectal manometry and Wexner scoring for faecal incontinence at baseline, after n-CRT (cT2-T3N0 cancer) and at 4 and 12 months after surgery. Water-perfused manometry measured anal tone at rest and during squeezing, rectal sensitivity and compliance. Twenty-seven and 10 patients, respectively, underwent TEM without (Group A) or with n-CRT (Group B). RESULTS: In Group A, anal resting pressure decreased from 68 ± 23 to 54 ± 26 mmHg at 4 months (P = 0.04) and improved 12 months after surgery (60 ± 30 mmHg). The Wexner score showed a significant increase in gas incontinence (59%), soiling (44%) and urgency (37%) rates at 4 months, followed by clinical improvement at 1 year (41%, 26% and 18%, respectively). In group B, anal resting pressure decreased from 65 ± 23 to 50 ± 18 mmHg at 4 months but remained stable at 12 months (44 ± 11 mmHg, P = 0.02 vs preoperative values - no significant difference compared with evaluation at 4 months). Gas incontinence, soiling and urgency were observed in 50%, 50%, 25% and in 38%, 12% and 12% of cases, respectively, 4 and 12 months after treatment. CONCLUSION: TEM does not significantly affect anal function. Instead, n-CRT does affect anal function but without causing major anal incontinence.

Treatment of rectovaginal fistula after colorectal resection with endoscopic stenting: long-term results.

AIM: To treat patients with rectovaginal fistula after anterior resection for cancer using self-expanding metal stents. METHOD: Ten patients of mean age of 56.3 years with rectovaginal fistula after colorectal resection for cancer were treated with endoscopic placement of a self-expanding metal stent. In three patients a diverting proximal stoma had been performed elsewhere. The rectal opening of the fistula was located from 3 to 10 cm from the anal verge (mean 6 cm). All patients had preoperative radiotherapy. In seven patients the stent was placed as the initial treatment while three referred patients had had multiple failed operations. RESULTS: There were no complications after the procedure. At a mean follow-up of 24 months the rectovaginal fistula has healed without major faecal incontinence in eight patients. In the remaining two the fistula has reduced significantly in size to allow a successful flap transposition. CONCLUSION: Endoscopic placement of a self-expanding metal stent is a valid adjunct to treat patients with rectovaginal fistula after colorectal resection for cancer.

Transanal ileoproctostomy is feasible in human cadavers.

AIM: An ileorectal bypass performed entirely through a transanal route has recently been described in an animal model. The present study aimed to demonstrate its technical feasibility in four human cadavers. METHOD: A transanal endoscopic microsurgery (TEM) device and endoscopic instruments were used. The principal steps of the procedure included insertion of the TEM device, rectostomy above the peritoneal reflection, peritoneoscopy using a standard gastroscope and delivery of the small bowel through the proctostomy to perform an anastomosis. RESULTS: The procedure was successfully completed using transanal access in all cases. The mean procedure time was 90 min. The bypass was patent, and the anastomosis between the intraperitoneal rectum and the terminal ileum was leakproof. CONCLUSION: Transanal ileoproctostomy is technically feasible in human cadavers. The procedure may become an alternative to stoma formation in selected patients with colonic obstruction.

Self-expandable metal stents in the treatment of benign anastomotic stricture after rectal resection for cancer.

AIM: To evaluate the use of self-expandable metallic stents to treat patients with symptomatic benign anastomotic stricture after colorectal resection. METHOD: Ten patients with a benign symptomatic anastomotic stricture after colorectal resection were treated with endoscopic placement of a self-expandable metal stent. RESULTS: The stent was placed successfully in all 10 patients without any major morbidity. At a mean follow-up of 18 months the stenosis was resolved successfully in 7 out 10 patients (70%). The remaining three patients were subsequently treated successfully with balloon dilatation. CONCLUSION: Self-expandable metal stents represent a valid alternative to balloon dilatation to treat patients with benign symptomatic anastomotic stricture after colorectal resection for cancer.

Transanal endoscopic microsurgery for rectal tumors: an option to radical surgery?

AIM: We present our experience in the treatment of rectal adenomas and selected cases of distal rectal cancer without evidence of nodal or distant metastasis (N0-M0) managed by transanal endoscopic microsurgery (TEM). This study examines our experience evaluating surgical morbidity, mortality and oncological outcome. METHODS: Eight hundred ten patients with rectal lesions (462 adenomas, 115 T1, 130 T2 and 103 T3) were enrolled. All patients staged preoperatively as T2 and T3 underwent preoperative high dose radiotherapy and since 1997 patients with less than 70 year old and good general conditions also preoperative chemotherapy. RESULTS: Minor complications were observed in 69 patients (8.5%) whereas major complications only in 5 patients (0.6%). Definitive histology confirmed adenomas in 431 cases (93%), while in 310 malignant lesions we had: 51 pT0 (14.7%), 127 pT1 (36.5%), 139 pT2 (39.9%) and 31 pT3 (8.9%). Sixteen (4.6%) patients (9 pT2 and 7 pT3) developed local recurrence whereas 6 (1.7%) patients distant metastasis. The survival rate at the end of follow-up was 100% for pT1 and 90% and 77% for pT2 and pT3 patients. CONCLUSION: TEM is safe and effective for rectal adenomas not removable endoscopically. T1 cancer may undergo local excision alone, while T2 and T3 lesions require preoperative radiochemotherapy. The results reported seems to be not very different in terms of local recurrence and survival rate to those after conventional surgery.

Self-expanding metal stents for treatment of anastomotic complications after colorectal resection.

Self-expanding metal stents (SEMS) can be used to treat patients with symptomatic anastomotic complications after colorectal resection. In the present case series, 16 patients with symptomatic anastomotic stricture after colorectal resection were treated with endoscopic placement of SEMS. Seven patients had a "simple" anastomotic stricture and nine patients had a fistula associated with the stricture. The anastomotic fistula healed without evidence of residual stricture or major fecal incontinence in seven of the nine patients. Overall the anastomotic stricture was resolved in 10 of the 16 patients. SEMS placement represents a valid adjunctive to treatment in patients with symptomatic anastomotic complications after colorectal resection for cancer.

Randomized clinical trial of endoluminal locoregional resection versus laparoscopic total mesorectal excision for T2 rectal cancer after neoadjuvant therapy.

BACKGROUND: In selected patients with early low rectal cancer, locoregional excision combined with neoadjuvant therapy may be an alternative treatment option to total mesorectal excision (TME). METHODS: This prospective randomized trial compared endoluminal locoregional resection (ELRR) by transanal endoscopic microsurgery versus laparoscopic TME in the treatment of patients with small non-advanced low rectal cancer. Patients with rectal cancer staged clinically as cT2 N0 M0, histological grade G1-2, with a tumour less than 3 cm in diameter, within 6 cm of the anal verge, were randomized to ELRR or TME. All patients underwent long-course neoadjuvant chemoradiotherapy. RESULTS: Fifty patients in each group were analysed. Overall tumour downstaging and downsizing rates after neoadjuvant chemoradiotherapy were 51 and 26 per cent respectively, and were similar in both groups. All patients had R0 resection with tumour-free resection margins. At long-term follow-up, local recurrence had developed in four patients (8 per cent) after ELRR and three (6 per cent) after TME. Distant metastases were observed in two patients (4 per cent) in each group. There was no statistically significant difference in disease-free survival (P = 0·686). CONCLUSION: In selected patients, ELRR had similar oncological results to TME. Unique Protocol ID: URBINO-LEZ-1995; registration number: NCT01609504 (http://www.clinicaltrials.gov).

Transanal endoscopic microsurgery for the treatment of selected patients with distal rectal cancer: 15 years experience.

BACKGROUND: Local therapy for early rectal cancer is a valid alternative to the classical radical operation, which has a higher morbidity and mortality rate. The use of high-dose preoperative radiation appears to enhance the options for sphincter-saving surgery even for T2-T3 rectal cancer patients with effective local control. The authors report their experience with transanal endoscopic microsurgery (TEM) used to manage selected cases of distal rectal cancer without evidence of nodal or distant metastasis (N0-M0). METHODS: The study enrolled 196 patients with rectal cancer (51 T1, 84 T2, and 61 T3). All the patients staged preoperatively as T2 and T3 underwent preoperative high-dose radiotherapy, and since 1997, patients younger than 70 years in good general condition also have undergone preoperative chemotherapy. RESULTS: Minor complications were observed in 17 patients (8.6%) and major complications in only 3 patients (1.5%). The definitive histology was 33 pT0 (17%), 73 pT1 (37%), 66 pT2 (34%), and 24 pT3 (12%). Eight patients (5 pT2 and 3 pT3) experienced local recurrence (4.1%). The rectal cancer-specific survival rate at the end of the follow-up period was 100% for pT1, 90% for pT2, and 77% for pT3 patients. CONCLUSIONS: Patients with T1 cancer and favorable histologic features may undergo local excision alone, whereas those with T2 and T3 rectal cancer require preoperative radiochemotherapy. The results in the authors' experience after TEM appear not to be substantially different in terms of local recurrence and survival rate from those described for conventional surgery.

Flank approach versus anterior sub-mesocolic access in left laparoscopic adrenalectomy: a prospective randomized study.

BACKGROUND: Laparoscopy is commonly recognized as the gold standard in adrenal surgery. The most used surgical access is at present the so-called flank approach. The aim of this study was to compare the flank approach and the anterior sub-mesocolic access carrying out left laparoscopic adrenalectomy (LA). METHODS: From January 2003 to January 2006 50 eligible left LAs were randomized to the flank (n = 25, group A) or sub-mesocolic transperitoneal approach (n = 25, group B). The two groups were similar concerning patient and lesion features. Comparing the two approaches, the main parameters analyzed, adjusted for tumor size and histology, were operating time (OpT), complication rate, and hospital stay. RESULTS: There were no converted procedures. Mean overall OpT was 76.4 min (54-96 min) versus 65.6 min (45-95 min) in group A and B, respectively (p = 0.001), while the OpT required to tie the adrenal vein was 42.8 min (26-55 min) and 24.5 min (16-41 min) (p = 0.000). Oral feeding resumed within 12-24 h in both groups. Mean hospital stay was 3 and 2.4 days in groups A and B, respectively (p = 0.04). Mean tumor size was similar in group A and B: 3.6 cm (1.5-6.5 cm) and 3.8 cm (2-6 cm), respectively. Definitive histology in groups A and B were: Cushing adenoma (6 and 4), Conn adenoma (5 and 6), pheochromocytoma (4 and 9), and incidentaloma (8 and 5, respectively). A myelolipoma and an adrenogenital adenoma were observed in group A and one carcinoma was observed in group B. CONCLUSIONS: Sub-mesocolic approach provides a statistically significant shorter OpT and hospital stay. Identification and early closure of the adrenal vein by means of a really minimal dissection and no-touch gland technique resulted in the main benefits of this approach.

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

BACKGROUND: This 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 T(2) N(0), G(1-2 )rectal cancer after neoadjuvant therapy with both treatments, incorporating a 5-year minimum follow-up period. METHODS: The study enrolled 70 patients whose malignancy was staged at admission as T(2) N(0), G(1-2 )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/m(2)/day). RESULTS: The 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. CONCLUSIONS: The study shows similar results between the two treatments in terms of local recurrences, distant metastases, and probability of survival for rectal cancer.

Thirteen years' experience with laparoscopic transcystic common bile duct exploration for stones. Effectiveness and long-term results.

BACKGROUND: The aim of the present study was to evaluate the effectiveness and long-term results of laparoscopic transcystic common bile duct exploration (TC-CBDE). METHODS: Ductal stones were present in 344 of 3212 patients (10.7%) who underwent laparoscopic cholecystectomy (LC). The procedure was completed laparoscopically in 329 patients (95.6%), with TC-CBDE performed in 191 patients (58.1%) who are the object of this study, or with a transverse choledochotomy in 138 cases (41.9%). RESULTS: Biliary drainage was employed in 71 of 191 cases (37.2%). Major complications occurred in 10 patients (5.1%), including retained stones in 6 (3.1%). Mortality was nil. No patients were lost to follow-up (median: 118.0 months; range: 17.6-168 months). No signs of bile stasis, no recurrent ductal stones and no biliary stricture were observed. At present 182 patients are alive with no biliary symptoms; 9 have died from unrelated causes. CONCLUSIONS: Long-term follow-up after laparoscopic TC-CBDE proved its effectiveness and safety for single-stage management of gallstones and common bile duct stones.

Laparoscopic radiofrequency renal ablation in patients with simultaneous visceral tumors: long-term follow-up.

PURPOSE: To report our experience with in situ laparoscopic radiofrequency ablation (RFA) of renal tumors. PATIENTS AND METHODS: From September 2000 to May 2002, two men, 81 and 71 years old, and one woman, 75 years old, were referred to our department for right renal clear-cell carcinoma <3.5-cm diameter. The 71- year-old patient had only one kidney. Because of the tumor location, the percutaneous route was not considered the approach of choice. Moreover, a simultaneous large right adrenal incidentaloma (myelolipoma) and a right colon cancer were known to be present in the second and third patient, respectively. The aforementioned findings suggested the laparoscopic route as a preferable technique to treat both the renal and the other morbidities. RESULTS: Under laparoscopic ultrasonography control of tine placement, a 20-minute thermoablation cycle at 100 degrees C mean temperature was performed. Including right colectomy and right adrenalectomy, the operative time was 120, 200, and 275 minutes, with postoperative hospital stays of 3, 4, and 6 days for the three patients, respectively. Abdominal CT scans after 1 and 4 weeks and then every 6 months confirmed complete treatment of the lesion at 44 months' average follow-up (range 36-56 months). CONCLUSION: When percutaneous access is not feasible or the patient should undergo another laparoscopic procedure simultaneously, laparoscopic RFA of renal tumors is feasible and effective, as shown by long-term follow-up.

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

BACKGROUND: Laparoscopic 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. METHODS: The 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. RESULTS: We 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. CONCLUSION: We suppose that laparoscopic surgery in the treatment of colo-rectal cancer is quite safe. However, further investigation is needed.

Transanal endoscopic microsurgery in rectal adenomas: experience of six Italian centres.

BACKGROUND/AIMS: Transanal endoscopic microsurgery is a minimally invasive technique that allows the excision of benign and selected malignant tumours. We present a study for evaluating surgical morbidity, mortality and local recurrence rate of patients with rectal adenomas treated with transanal endoscopic microsurgery in six different Italian centres following the same protocol. METHODS: A total of 882 patients with rectal lesions (adenomas and early stage of carcinomas) underwent transanal endoscopic microsurgery in six different Surgical Departments from January 1993 to October 2004. Five hundred and ninety patients had preoperative diagnosis of adenomas but 588 patients were regularly followed up to determine treatment efficacy in terms of local recurrence rate. RESULTS: The study involved 588 patients, with a median age of 66 years (25th percentile-75th percentile=58-71 years). No postoperative mortality was reported. Intraoperative complications were observed in three patients (0.5%). Minor complications occurred in 48 patients (8.2%) whereas major complications were found only in 7 patients (1.2%). Definitive histology confirmed adenomas in 530 cases (90.1%). Two patients (0.3%) were lost to follow-up so were not included in the paper. At median follow-up of 44 months (25th percentile-75th percentile=15-74 months), 23 (4.3%) adenomas recurred and were successfully retreated by transanal endoscopic microsurgery [20 cases (87%)] and by conventional surgery [3 patients (13%)]. No further recurrences were observed at subsequent follow-up. Thirty-one (5.3%) patients died during follow-up for old age, cardiac disease, etc. CONCLUSIONS: Transanal endoscopic microsurgery is, in our experience, an effective method for local resection of benign rectal tumours with morbidity of 11.4%, no postoperative mortality and with a percentage of local recurrence of 4.3%.

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

BACKGROUND: 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. METHODS: One hundred patients with rectal cancer (54 uT2 and 46 uT3 uN0 tumours) were enrolled. All patients underwent preoperative radiotherapy followed by local excision by means of transanal endoscopic microsurgery. RESULTS: Definitive histological examination revealed nine pT1, 54 pT2 and 19 pT3 tumours. A complete response (R0) or microscopic residual tumour (R1mic) was found in three and 15 patients respectively. Minor complications occurred in 11 patients and major complications in two. At a median follow-up of 55 (range 7-120) months, the local failure rate was 5 per cent and metastatic disease was found in two patients. The cancer-specific survival rate at 90 months' follow-up was 89 per cent, and the overall survival rate 72 per cent. Salvage abdominoperineal resection was performed in three patients, two of whom were disease free at 15 and 19 months. CONCLUSION: Treatment of small uT2 and uT3 uN0 rectal cancers with preoperative high-dose radiotherapy followed by transanal endoscopic microsurgery is an acceptable alternative to conventional radical resection.

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 alpha-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.

Sub-mesocolic access in laparoscopic left adrenalectomy.

BACKGROUND: This article reports an alternative laparoscopic access to left adrenal gland. METHODS: From January 1994 to August 2004, 209 laparoscopic adrenalectomies were performed in our Department. Indications were Conn adenoma (55 cases), incidentaloma (64), Cushing adenoma (45), pheochromocytoma (32), adreno-genital syndrome (two), mielolipoma (two), and metastatic mass(nine). Of 209, in 12 cases the left adrenalectomy was performed through a submesocolic access (seven pheochromocytoma, two incidentaloma, two Cushing adenoma, one Conn adenoma,). The identification and closure of the adrenal vein with minimal gland manipulation resulted the main benefit of this approach. Moreover, the adrenalectomy was performed with minimal anatomical dissection. RESULTS: No mortality or major complications occurred. During the operation, the blood pressure and cardiac rhythm were significantly more stable, in the group of patients who underwent a left adrenalectomy by the submesocolic approach compared to the anterior or flank lateral transperitoneal group. CONCLUSIONS: Left adrenal lesions, as selected cases of pheochromocytoma, can be safely treated by laparoscopic submesocolic access.

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.

BACKGROUND: This 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 T(2)-N(0) low rectal cancer. METHODS: The study enrolled 40 patients with T2-N(0) rectal cancer, randomizing 20 to TEM (arm A) and 20 to LR (arm B). RESULTS: After 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. CONCLUSIONS: The findings show comparative results between the two study arms in terms of probability of failure and survival.