"High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial" (HIGHLOW trial).

BACKGROUND: The position of arterial ligation during laparoscopic anterior rectal resection with total mesorectal excision can affect genito-urinary function, bowel function, oncological outcomes, and the incidence of anastomotic leakage. Ligation to the inferior mesenteric artery at the origin or preservation of the left colic artery are both widely performed in rectal surgery. The aim of this study is to compare the incidence of genito-urinary dysfunction, anastomotic leak and oncological outcomes in laparoscopic anterior rectal resection with total mesorectal excision with high or low ligation of the inferior mesenteric artery in a controlled randomized trial. METHODS/DESIGN: The HIGHLOW study is a multicenter randomized controlled trial in which patients are randomly assigned to high or low inferior mesenteric artery ligation during laparoscopic anterior rectal resection with total mesorectal excision for rectal cancer. Inclusion criteria are middle or low rectal cancer (0 to 12 cm from the anal verge), an American Society of Anesthesiologists score of I, II, or III, and a body mass index lower than 30. The primary end-point measure is the incidence of post-operative genito-urinary dysfunction. The secondary end-point measure is the incidence of anastomotic leakage in the two groups. A total of 200 patients (100 per arm) will reliably have 84.45 power in estimating a 20% difference in the incidence of genito-urinary dysfunctions. With a group size of 100 patients per arm it is possible to find a significant difference (α = 0.05, ß = 0.1555). Allowing for an estimated dropout rate of 5%, the required sample size is 212 patients. DISCUSSION: The HIGHLOW trial is a randomized multicenter controlled trial that will provide evidence on the merits of the level of arterial ligation during laparoscopic anterior rectal resection with total mesorectal excision in terms of better preserved post-operative genito-urinary function. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02153801 Protocol Registration Receipt 29/5/2014.

Subtotal gastrectomy with D2 dissection by minimally invasive surgery for distal adenocarcinoma of the stomach: results and 5-year survival.

BACKGROUND: The purpose of this study is to assess outcomes and 5-year survival after subtotal gastrectomy (SG) for early and advanced distal adenocarcinoma with D2 dissection performed by minimally invasive surgery (MIS). METHODS: From June 2000 to October 2009 a total of 70 patients with adenocarcinoma of the lower third of the stomach underwent SG with D2 nodal clearance by MIS. This series enrolled 37 patients with early gastric cancer (EGC) and 33 with advanced gastric cancer (AGC). SG was attempted by conventional laparoscopy (CL) in 52 cases and by robot-assisted (RA) technique in 18. Clinical and histopathologic results with 5-year survival were analyzed. RESULTS: No intraoperative complication was registered. Conversion to laparotomy was required in five patients. Overall, the mean operating time for SG was 254 min (range = 145-460) and estimated mean blood loss was 146 ml (range = 45-250). Postoperative complications occurred in seven patients, including two duodenal leakages none of which required laparotomy. There were two postoperative deaths, one caused by hepatic failure and one by hemorrhagic stroke. Preoperative understaging occurred in ten cases (three were AGC). On average, 30 ± 8 lymph nodes were collected. The distance of proximal resection margin was 6.6 cm (range = 4-8.5 cm). Short-term results were equal with those of laparoscopic and RA gastrectomy. The mean hospital stay of all patients was 10 days (range = 7-24). The mean follow-up span was 53 months (range = 3-112). Relapse of disease occurred in 12 patients, 10 of whom died from the disease and their mean survival was 25 months (range = 12-38). The overall 3-year survival was 85% for CL gastrectomy and 78% for RA gastrectomy, but this difference was not significant with the log rank test (p > 0.05). The overall 5-year survival was 81% (97% for EGC and 67% for AGC). CONCLUSION: D2 subtotal gastrectomy performed by MIS is reproducible and safe. The long-term outcomes and 5-year survival are acceptable. Extended lymphadenectomy was carried out for both EGC and AGC so as to ensure adequate nodal clearance and compensate preoperative underestimation.

Hybrid NOTES transvaginal cholecystectomy: operative and long-term results after 18 cases.

PURPOSE: Natural orifice transluminal endoscopic surgery (NOTES) is a novel technique that aims at reducing or abolishing skin incisions and potentially also postoperative pain. The purpose of this study was to analyse operative and long-term results of a series of hybrid transvaginal cholecystectomy. MATERIALS AND METHODS: Between July 2007 and May 2009, transvaginal NOTES cholecystectomy for symptomatic cholelithiasis was performed by a hybrid technique in 18 women (mean age 54 years), including four women with a body mass index >30 kg/m(2). Dissection was conducted in the first four cases by a round-tip unipolar electrode (UE) introduced through the operative channel of the endoscope coming from the vagina and in the last 14 cases by a ultrasonic scalpel (US) introduced through a 5-mm abdominal port. The short-term outcomes and the long-term results of the two methods were compared. RESULTS: The transvaginal approach entailed no intraoperative complication and no conversion. The overall mean duration of procedures was 75 min (range 40-190). In the first four cases (UE), the operating time was 148 min (range 140-190), whilst in the last 14 (US), it was considerably shorter, 53 min (range 40-60, p < 0.01). We experienced one biliary leak in the UE group, whilst morbidity with US was nil (p < 0.005). The biliary leak healed in 7 days with nasobiliary drainage. No other complications were encountered in either group. The mean follow-up was 12 months (range 1-22), and none of the patients has complained of dyspareunia or other colpotomy-related complications so far. CONCLUSIONS: Until specifically designed endoscopic tools are available for NOTES, the hybrid technique with US dissection conducted through a 5-mm port should be preferred in transvaginal cholecystectomy in order to shorten the duration of surgery and make this approach effective, safe and reproducible. After a mean follow-up of 1 year, none of our patients has complained of any problem related to transvaginal approach.

Laparoscopic repair of incisional hernias located on the abdominal borders: a retrospective critical review.

BACKGROUND: The aim of this study was to assess feasibility and results of laparoscopic approach to repair incisional hernias of the abdominal borders, the weakest points of abdominal wall. METHODS: Since 2002 through 2008 a total of 39 patients with fascial defects of the abdominal borders underwent laparoscopic repair. The defects were suprapubic (n=18), subxiphoidal (n=15), and lateral sided (n=6). The body mass index was >oe=30 Kg/m2 in 19 patients. The parietal defects was measured both externally and from within the peritoneal cavity and 56% of meshes were fixed only by tacks, especially in suprapubic site. RESULTS: The mean operating time was 161.8+/-25 minutes. There was 1 intraoperative complication, an intestinal injury repaired laparoscopically. Conversion was needed in 1 patient for massive adhesions. Postoperative early surgical complications were 7 (1 seroma). Morbidity in obese and nonobese patients showed no statistically relevant difference (P>0.05). There was no postoperative death. Mean hospital stay was 5.1+/-3 days. The mean follow-up was 37 months and recurrence was observed in 3 cases. CONCLUSIONS: The onlay laparoscopic approach for repair of incisional hernias of the abdominal borders can warrant good results. Obesity is not a contraindication to laparoscopic repair. Anyway, further experiences are necessary to confirm these results.

Laparoscopic bilateral simultaneous adrenalectomy: results of 11 operations.

BACKGROUND: This study was undertaken to evaluate the outcomes of the simultaneous bilateral laparoscopic adrenalectomy. MATERIALS AND METHODS: This was a retrospective study, including 11 patients with bilateral adrenal lesions, affected by Cushing's syndrome (n=2), Cushing's disease (n=6), pheochromocytoma (n=2), and 1 adrenocorticotrophin-hormone-dependent hypercortisolism of unknown origin. RESULTS: Elevan bilateral adrenalectomies were carried out by the laparoscopic approach with no conversions. The operations were performed in 7 cases by the lateral transperitoneal adrenalectomy (LTLA), in 3 by the posterior approach (PRA), and in 1 by the combined approach. The mean size of the masses was 5 cm. (range, 4-13). The average operating time was 245 minutes for LTLA and 218 minutes for PRA (P<0.05). The estimated mean blood loss was 87+/-36 mL (range, 20-150). No patients required transfusions. The mean hospital stay was 5+/-1.8 days (range, 4-7). The mean follow-up was 34 months (range, 2-96). CONCLUSIONS: Our study confirms that the bilateral adrenalectomy by the minimally invasive technique is safe and effective, affording acceptable blood loss and morbidity with a short hospital stay.

Transvaginal endoscopic cholecystectomy in human beings: preliminary results.

INTRODUCTION: The exciting concept of performing surgery in the peritoneal cavity without abdominal incisions by means of flexible endoscopes introduced through natural orifices-natural orifice transluminal endoscopic surgery (NOTES) has been widely investigated in recent years in experimental settings. However, experience with this procedure in human beings is still lacking. In this paper, we report the preliminary results of a small consecutive series of transvaginal endoscopic cholecystectomies. METHODS: A standard double-channel gastroscope introduced into the abdominal cavity through a posterior colpotomy was used to perform the cholecystectomy. The introduction of a 5-mm trocar in the left-upper abdominal quadrant was mandatory to create and monitor the pneumoperitoneum and allow the application of the standard laparoscopic clips. This port was also used to introduce a grasper that assisted in the exposure of the gallbladder. The gallbladder was removed through the vagina and was protected in a plastic bag. RESULTS: Since July 2007, 3 patients were successfully operated on by this approach, including 1 morbidly obese woman with a body mass index (BMI) of 45. The mean operative time was 136 minutes (range, 110-190). No postoperative complications occurred, and the patients did not complain of pain at both access sites. At the 1-month follow-up, none of the patients complained of dyspareunia. CONCLUSIONS: The transvaginal cholecystectomy is feasible, safe, and reproducible in women within a wide range of BMI. NOTES might dramatically change the way surgery will be conceived and performed in the future, as it holds the potential to abolish the historic association of surgery with pain and scars.

Laparoscopic pancreaticoduodenectomy: a retrospective review of 19 cases.

The role of laparoscopic techniques in pancreatic surgery is still controversial especially regarding to exocrine malignancies. Operative time, conversion rate, adequacy of dissection, and morbidity do represent factors of major concern. Whereas laparoscopic resection of left sided pancreatic lesions requires no anastomosis and therefore has gained worldwide acceptance over the last years, excision of cephalic lesions by mimimal access has little place in surgeons' practice because of its technical complexity and duration of surgery. This study was designed to assess the feasibility and results of laparoscopic pancreaticoduodenectomy for neoplasms of the pancreatic head, analyzing steps of learning curve, conversion rate, and short-term outcomes. From August 2002 to December 2006, 19 patients affected by pancreatic neoplasm of the head were approached by minimally invasive technique. A video-assisted procedure with pancreaticoduodenal resection and anastomoses fashioned through a midline minilaparotomy of 7 cm was achieved in 7 patients. Conversion to laparotomy was required in 6 patients, in 3 for bleeding and in 3 for difficulties in dissection. Cephalic pancreatoduodenectomy was achieved by thorough intracorporeal technique in 6 patients. Mortality was nil. Oncologic principles with adequate lymphadenectomy and resection margins were respected and short-term outcomes and mean survival were quite acceptable and equal to those of conventional surgery.

Results of laparoscopic anterior resection for rectal adenocarcinoma: retrospective analysis of 157 cases.

BACKGROUND: Laparoscopic excision of rectal tumors has gained favor in the last decade and several issues have reported encouraging results: still, the use of laparoscopy remains open to debate. The aim of the current study is to assess the reliability of laparoscopic anterior resection (LAR) for rectal cancer analyzing short-term outcomes and long-term survival. METHODS: The charts of 157 patients were reviewed retrospectively after anterior resection for rectal adenocarcinoma performed by minimal access. Patients undergoing emergency surgery were excluded. LAR was excluded in presence of preoperative features at computed tomography (CT) scan suggesting bulky tumors unresectable by laparoscopy or in case of anesthesiologic contraindications. Conversion rate and functional and oncologic outcomes were analyzed. Data on long-term results and survival were evaluated. RESULTS: LAR was performed in 157 patients, and conversion to laparotomy was required in 12 cases. Mean operation time for nonconverted patients was 229 minutes (overall 238 minutes). Total mesorectal excision (TME) was performed in tumors of the mid and low rectum and a temporary ileostomy was performed in 56 patients. The mean length of hospital stay (LOS) was 10.5 days. Morbidity of anterior resection included 17 anastomotic leaks after laparoscopic surgery (LS; 5 in the converted patients). Conversion increased significantly the risk of leak (P < .005). Two leaks caused death. The mean number of nodes collected was 12. The incidence of local relapse was 4%, and the rate of anastomotic recurrence was nil. Survival probability with LS was .73 at 5 years. Patients in stage III took advantage of adjuvant treatment and had a better survival than patients in stage II (P = not significant [NS]). CONCLUSIONS: The outcomes of this study suggest that LAR for rectal cancer is a reliable procedure. Oncologic requirements were respected; parameters such as length of specimen, distal margin, and number of nodes retrieved were quite acceptable. Incidences of local recurrence and long-term survival were comparable with those of other series.

Laparoscopic repair of incisional hernia: Outcomes of 100 consecutive cases comprising 25 wall defects larger than 15 cm.

BACKGROUND: Minimal access surgery for incisional hernia repair is still debated, especially for large and giant wall defects. This study was undertaken to analyze the results of the use of the laparoscopic technique in incisional hernias smaller and larger than 15 cm of diameter. METHOD: From 2002 to 2007 a total of 100 patients with incisional hernia were operated on by laparoscopy and were included in this study. As much as 38 patients were obese, with a body mass index (BMI) > 30 kg/m(2). The mean follow-up span was 24 months (range = 2-58). The fascial defect was recurrent in 19 patients, in 13 after previous repair with mesh and in 6 after repair without mesh. The wall defect was larger than 15 cm in 25 patients and in 6 of them it was 20 cm or larger as measured from within the peritoneal cavity. RESULTS: The mean operating time was 152 +/- 25 min (range = 45-275), and for defects larger than 15 cm it was 205 +/- 101 min (range = 85-540). Two patients with massive adhesions needed conversion to open surgery, one after an intraoperative injury of an intestinal loop. Postoperative complications occurred in 23 patients; local complications were 10. Pulmonary embolism caused death in one obese patient. Morbidity and hospital stay were similar in obese and nonobese patients and the differences were not statistically relevant (p > 0.05). The outcomes in patients with wall defects larger than 15 cm showed no significant difference with outcomes of the remaining patients with smaller defects (p > 0.05). Recurrence occurred in three cases, and in one case local infection led to removal of the mesh. CONCLUSIONS: Minimal access procedures can provide good results in the repair of incisional hernia, even when the diameter is larger than 15 cm. Obesity is not a contraindication to laparoscopic repair. Further studies are expected to confirm these promising results.

Outcomes of laparoscopic adrenalectomy. Clinical experience with 68 patients.

The aim of this study was to analyze feasibility and outcomes of laparoscopic adrenalectomy (LA). Pathology, size and bilateral site of lesions were considered. Between December 1998 and May 2007 in our institution a total of 68 patients of mean age of 53 years underwent unilateral (n=57) or bilateral (n=11) LA. Adrenal masses averaged 5.4cm in size (range 1.2-13cm) and 56.7g in weight (range 10-265) including 71 benign and 8 malignant lesions. A total of 79 adrenal glands were resected, 44 right sided and 35 left sided. Removal was complete in 77 cases and partial (sparing adrenalectomy) in 1 patient affected by bilateral pheochomocytoma. Three left adrenalectomies for pheochromocytoma were robot-assisted. The transperitoneal lateral approach was preferred and the posterior retroperitoneal approach was adopted in 5 patients. The mean duration of surgery for each LA was 138+/-90min and 3.8 trocar were used on average (range 3-6). Conversion was needed in 3 cases owing to difficult dissection of large masses. Estimated mean blood loss for each LA was 95+/-30ml and it was greater for bilateral LA. Mortality was nil and morbidity was 5.8%. The average length of hospital stay (LOS) in surgical unit was 4+/-2.4 days (range 2-8). Patients affected by hormone secreting or bilateral lesions, by unilateral or bilateral pheochromocytoma and by bilateral Cushing's disease were transferred to the endocrinological ward so that their overall hospital stay was prolonged to 9+/-2.8 days on average (range 7-17). Mean duration of follow-up of patients was 38 months (range 2-100) and demonstrated acceptable endocrine results. Three primary cortical carcinomas were discovered as chance findings on histologic examination. While long-term results after LA for cortical carcinomas were poor and LA is not recommended in such cases, long-term results after LA for adrenal metastases were encouraging.

[Splenectomy in haematologic diseases. Clinical indications and surgical technique]. / La splenectomia nelle malattie ematologiche. Indicazioni clinicopatologiche e aspetti di tecnica chirurgica.

After the introduction of corticosteroids fifty years ago the indications for splenectomy in benign haematological diseases became more controversial, also due to the morbidity and mortality associated at that time with open splenectomy. The advent of minimally invasive techniques has provided safe procedures for removal of the spleen in cases of benign as well as malignant haematological disease. Laparoscopic splenectomy has been performed for spleens of normal size or larger size or weight. In this study the indications in haematological diseases and the results after splenectomy are analysed. From June 1998 to December 2004 107 patients with benign or malignant haematological disease were referred to our unit for splenectomy. Splenomegaly was defined as a spleen diameter > 15 cm and weight > 400 g and was present in 53% of cases in this series. Open splenectomy was carried out in 30 cases and laparoscopic splenectomy in 77. Operating time, blood loss, conversion rate, need for transfusion, complications, length of hospital stay and operative morbidity were analysed for both open and laparoscopic procedures. In the laparoscopic splenectomy group the outcomes after removal of spleens < 15 cm and > 15 cm were compared. Clinical results after splenectomy in haemolytic anaemia and idiopathic thrombocytopenic purpura are reported. In the open splenectomy group the spleens were larger and heavier, hence the operating time was greater than in the laparoscopic splenectomy group. The mean age of patients in the open group was 65 years as against 43 years in the laparoscopic group. Morbidity was 23% in the open group and 10% in the laparoscopic group. Mortality was nil in both groups. The overall conversion rate in the laparoscopic group was 2.6% owing to extensive adhesions and bleeding in 2 large spleens measuring > 27 cm and weighing > 2 kg (conversion rate for larger spleens: 6.2%). Spleens > 15 cm were associated with greater blood loss (p < 0.01), longer operating times and a longer hospital stay. No cases of overwhelming post-splenectomy infection were registered in either group. The healing rate for idiopathic thrombocytopenic purpura after splenectomy was 87%, while for haemolytic anaemia it was 100%. In this study splenomegaly was associated with malignant haematological disease occurring in patients aged 65 on average in whom an open splenectomy was generally carried out. Benign diseases occurred in patients aged 43 on average in whom laparoscopic splenectomy was the preferred procedure. Conversion rate, morbidity and length of hospital stay were comparable with those of other series. Laparoscopic splenectomy can be considered the gold standard procedure for benign disease in young patients and also as a safe procedure in selected cases of malignant haematological disease.

[Liver trauma: experience in the management of 252 cases]. / I traumi epatici: esperienza di trattamento di 252 casi.

The treatment of liver traumas has evolved considerably over recent decades with the possibility of non-operative management and arteriographic embolisation for selected patients in haemodynamically stable conditions. The aim of the study was to compare two periods with different approaches to the management of blunt or penetrating liver injuries. From January 1989 to October 2004, 252 patients were admitted to the emergency surgery department of Niguarda Hospital in Milan for liver traumas. Hepatic lesions accounted for 66% of abdominal lesions due to trauma and were classified according to the Organ Injury Scaling system. Abdominal ultrasound and CT scans were used to investigate the injuries. The study consisted of two periods: during the first period (1989-1993) surgery was the only treatment for trauma-induced hepatic lesions of any grade. Damage control surgery was employed for unstable patients undergoing laparotomy. From 1994 on, grade 1-2 injuries in patients with haemodynamically stable conditions were treated by non-operative management and grade 3 injuries by embolisation. In this second period only unstable patients with active bleeding or haemoperitoneum >500 ml with grade 3-5 injuries underwent laparotomy. The overall mortality for liver traumas was 27% (68/252) and was intraoperative in 97% of cases (66/68). Deaths were due to liver haemorrhage in 30 cases and to bleeding from extrahepatic or extra-abdominal injuries in the other 38 cases. Liver trauma was therefore directly responsible for mortality in as many as 12% of cases (30/252). The present study analysed two periods characterised by different approaches to the management of liver trauma. In the first period, laparotomy was the only choice, whereas subsequently non-operative management came to play an important role in haemodynamically stable patients and proved to be a safe method in selected cases. Major liver resections are seldom indicated in liver injuries. Damage control surgery has been practised since the first period and, before any surgical manoeuvres are performed, still represents a valuable tool to guarantee haemodynamic stability, which is the crucial factor for the outcome of liver resections for trauma.