Minimally Invasive Versus Open Esophageal Resection: Three-year Follow-up of the Previously Reported Randomized Controlled Trial: the TIME Trial.

OBJECTIVE: The aim of this study was to investigate 3-year survival following a randomized controlled trial comparing minimally invasive with open esophagectomy in patients with esophageal cancer. BACKGROUND: Research on minimally invasive esophagectomy (MIE) has shown faster postoperative recovery and a marked decrease in pulmonary complications. Debate is ongoing as to whether the procedure is equivalent to open resection regarding oncologic outcomes. The study is a follow-up study of the TIME-trial (traditional invasive vs minimally invasive esophagectomy, a multicenter, randomized trial). METHODS: Between June 2009 and March 2011, patients with a resectable intrathoracic esophageal carcinoma, including the gastroesophageal junction tumors (Siewert I), were randomized between open and MI esophagectomy with curative intent. Primary outcome was 3-year disease-free survival. Secondary outcomes include overall survival, lymph node yield, short-term morbidity, mortality, complications, radicality, local recurrence, and metastasis. Analysis was by intention-to-treat. This trial is registered with the Netherlands Trial Register, NTR TC 2452. Both trial protocol and short-term results have been published previously. RESULTS: One hundred fifteen patients were included from 5 European hospitals and randomly assigned to open (n = 56) or MI esophagectomy (n = 59). Combined overall 3-year survival was 40.4% (SD 7.7%) in the open group versus 50.5% (SD 8%) in the minimally invasive group (P = 0.207). The hazard ratio (HR) is 0.883 (0.540 to 1.441) for MIE compared with open surgery. Disease-free 3-year survival was 35.9% (SD 6.8%) in the open versus 40.2% (SD 6.9%) in the MI group [HR 0.691 (0.389 to 1.239). CONCLUSIONS: The study presented here depicted no differences in disease-free and overall 3-year survival for open and MI esophagectomy. These results, together with short-term results, further support the use of minimally invasive surgical techniques in the treatment of esophageal cancer.

Lethal intestinal perforation after foreign body ingestion in a superobese patient.

Accidental ingestion of foreign bodies is common in the general population. Most foreign bodies pass through the entire digestive tract without incidents. However, in some cases, the ingested foreign body can cause complications such as acute abdomen due to intestinal perforation and even death. Bowel perforation may not be more common in the massively obese than in the normal-weight population but may be more problematic. We describe a super-obese female (body mass index, 52.3 kg/m2) who underwent emergency surgery for small-bowel perforation caused by an ingested foreign body (fish bone); the patient died despite segmental intestinal resection and intensive care.

Incarcerated umbilical hernia in a super-super-obese patient.

Abdominal wall hernias are more prevalent in the morbidly obese. Incarceration of external hernias is a relatively common process in adults and is associated to a high rate of complications and mortality. We present the case of a morbidly super-super-obese patient (body mass index, 80 kg/m(2)) who underwent emergency surgery for an incarcerated umbilical hernia; the patient died despite segmental intestinal resection, hernia repair using mesh, and intensive care.

Hepatic evisceration after cholecystectomy in a superobese patient.

Gallbladder pathology, in general, and cholelithiasis, in particular, are more common in the morbidly obese. Obesity is a risk factor for conversion to open surgery in laparoscopic cholecystectomy. Obesity is also a risk factor for evisceration after laparotomy in adults. Hepatic evisceration after cholecystectomy is rare. We describe a case of right liver lobe evisceration diagnosed by abdominal computed tomography in a superobese patient (body mass index 57 kg/m(2)) after emergency laparoscopic surgery for acute calculous cholecystitis converted to open surgery.

Hepatic evisceration after cholecystectomy in a super obese patient.

Gallbladder pathology in general and cholelithiasis in particular are more common in the morbidly obese. Obesity is a risk factor for conversion to open surgery in laparoscopic cholecystectomy. Obesity is also a risk factor for evisceration after laparotomy in adults. Hepatic evisceration after cholecystectomy is rare. We describe a case of right liver lobe evisceration diagnosed by abdominal computed tomography (CT) in a super obese patient (BMI 57 kg/m2) after emergency laparoscopic surgery for acute calculous cholecystitis converted to open surgery.

Predictive factors for post-operative respiratory infections after esophagectomy for esophageal cancer: outcome of randomized trial.

BACKGROUND: The first and only randomized trial comparing open esophagectomy (OE) with minimally invasive esophagectomy (MIE) showed a significant lower incidence of post-operative respiratory infections in the patients who underwent MIE. In order to identify which specific factors are related to a better respiratory outcome in this trial an additional analysis was performed. METHODS: This was a prospective, multicenter, randomized controlled trial. Eligible patients, with a resectable intrathoracic esophageal carcinoma, including the gastro-esophageal (GE) junction tumors and Eastern Cooperative Oncology Group ≤2, were randomized to either MIE or OE. Respiratory infection investigated was defined as a clinical manifestation of (broncho-) pneumonia confirmed by thorax X-ray and/ or Computed Tomography scan and a positive sputum culture. A logistic regression model was used. RESULTS: From 2009 to 2011, 115 patients were randomized in 5 centers. Eight patients developed metastasis during neoadjuvant therapy or had an irresectable tumor and were therefore excluded from the analysis. Fifty-two OE patients were comparable to 55 MIE patients with regard to baseline characteristics. In-hospital mortality was not significantly different [2% (open group) and 4% (MIE group)]. A body mass index (BMI) ≥26 and OE were associated with a roughly threefold risk of developing a respiratory infection. CONCLUSIONS: Overweight patients and OE are independently associated with a significant higher incidence of post-operative respiratory infections, i.e., pneumonia.

Surgical techniques, open versus minimally invasive gastrectomy after chemotherapy (STOMACH trial): study protocol for a randomized controlled trial.

BACKGROUND: Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less perioperative blood loss and faster patient recovery. It also maintains similar results with regard to tumor resection margins and oncological long-term survival. In gastric cancer the role of laparoscopic surgery remains unclear. Current recommended treatment for gastric cancer consists of radical resection of the stomach, with a free margin of 5 to 6 cm from the tumor, combined with a lymphadenectomy. The extent of the lymphadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, it is imperative that a novel surgical technique, such as minimally invasive total gastrectomy, should be non-inferior with regard to radicality of surgery and lymph node yield. METHODS/DESIGN: The Surgical Techniques, Open versus Minimally invasive gastrectomy After CHemotherapy (STOMACH) study is a randomized, clinical multicenter trial. All adult patients with primary carcinoma of the stomach, in which the tumor is considered surgically resectable (T1-3, N0-1, M0) after neo-adjuvant chemotherapy, are eligible for inclusion and randomization. The primary endpoint is quality of oncological resection, measured by radicality of surgery and number of retrieved lymph nodes. The pathologist is blinded towards patient allocation. Secondary outcomes include patient-reported outcomes measures (PROMs) regarding quality of life, postoperative complications and cost-effectiveness. Based on a non-inferiority model for lymph node yield, with an average lymph node yield of 20, a non-inferiority margin of -4 and a 90% power to detect non-inferiority, a total of 168 patients are to be included. DISCUSSION: The STOMACH trial is a prospective, multicenter, parallel randomized study to define the optimal surgical strategy in patients with proximal or central gastric cancer after neo-adjuvant therapy: the conventional 'open' approach or minimally invasive total gastrectomy. TRIAL REGISTRATION: This trial was registered on 28 April 2014 at Clinicaltrials.gov with the identifier NCT02130726 .

Retroperitoneal paragangliomas in obese patients.

Obesity, the most significant metabolic problem in the world today, is associated with a wide range of diseases, including endocrine disorders. Paraganglioma is a rare chromaffin cell tumor that develops from the neural crest cells of the neuroendocrine system. Retroperitoneal paragangliomas can represent a surgical challenge due to their close relation to large vessels. We report two cases of functioning retroperitoneal paraganglioma in type-I obese patients (case 1: female; weight, 77 kg; body mass index, 30.1 kg/m(2); case 2: male; weight, 92 kg; body mass index, 31.1 kg/m(2)) who underwent elective endocrine surgery. The tumors (one interaortocaval and the other above the iliac artery) were completely excised by laparotomy without postoperative complications.

Laparoscopic adrenalectomy for a large pheochromocytoma in a morbidly obese patient.

The high prevalence of obesity is associated with diverse health problems, including endocrine disorders. Laparoscopic adrenalectomy has become the preferred approach for removal of the adrenal gland, but several authors still debate the role of laparoscopic adrenalectomy in pheochromocytoma. We describe a case of a morbidly obese man (weight, 142 kg; body mass index, 40.2 kg/m(2)) who underwent elective laparoscopic adrenalectomy for a large right pheochromocytoma without incidences.

Gastric necrosis: a possible complication of the use of the intragastric balloon in a patient previously submitted to nissen fundoplication.

The temporary use of the bioenterics intragastric balloon in morbid obesity is increasing worldwide. Generally, this is an effective procedure that helps bring about satisfactory weight loss and improvement in comorbidities after 6 months. However, in some cases, it causes complications such as acute abdomen due to gastric perforation and even death. We describe the case of a type II obese female (weight, 88 kg; body mass index, 35.2 kg/m(2)) who underwent emergency surgery for gastric necrosis caused by bioenterics intragastric balloon; the patient required total gastrectomy and intensive care.

[Gastric cancer and laparoscopy: analysis of data from the national register of laparoscopic gastric surgery]. / Cáncer gástrico por laparoscopia: análisis de los datos del Registro Nacional de Cirugía Gástrica por Laparoscopia.

OBJECTIVE: To study the data from the Laparoscopic Gastric Surgery Spanish National Register of laparoscopic Gastric Surgery and to analyse the type of surgery, the conversion to laparotomy, postoperative complications and mortality. PATIENTS AND METHOD: From March 2005 to July 2008, details of 302 laparoscopic gastric surgical interventions were sent to the Association of Spanish Surgeons web-site. Details of surgical technique, reconversion, clinical and pathological data, morbidity and mortality were collected and analysed. RESULTS: A total of 245 patients had gastric adenocarcinoma, 35 of them stromal tumours and 22 other gastric pathologies. In gastric adenocarcinoma patients, resection was performed in 232 cases (95%). The most frequent histology was intestinal, mainly located in the distal third of the stomach, with 34% of the tumours being locally advanced. D2 lymphadenectomy was performed in 117 cases, D1 in 105, and D0 in 6. Reconversion was needed in 21 cases (9%), with technical difficulty being the most frequent cause. Postoperative complications were reported in 72 patients (31%), with anastomotic leak being one of the most significant. Postoperative mortality was 6%, with sepsis due to anastomotic leak and cardiac or respiratory complications the most frequent causes. The mean hospital stay of patients without complications was 9.2 +/- 3 days. CONCLUSIONS: Laparoscopic gastrectomy for gastric cancer is a feasible but technically demanding procedure. Potential benefits of minimal invasive surgery can be reduced due to a high rate of postoperative complications.

[Evolution of laparoscopic adrenal surgery in a general surgery department]. / Evolución de la cirugía laparoscópica adrenal en un servicio de cirugía general.

OBJECTIVE: To evaluate the reproducibility, safety and short-term results of laparoscopic adrenal surgery during the first few years after its introduction in our department. PATIENTS AND METHOD: A prospective analysis of data of all patients who underwent laparoscopic adrenalectomy in our endocrine surgical unit over a 4-year period. Demographic data, medical history, diagnosis, adrenal and tumour size, technique, conversions, complications and hospital stay were re-viewed. All patients were treated with a laparoscopic transperitoneal lateral approach. RESULTS: Twenty-four laparoscopic adrenalectomies were performed on 23 consecutive patients (one underwent bilateral adrenalectomy). There were 15 females and 8 males; the mean age was 49.6 years (range, 20-72). There were obesity and vascular hypertension in half of the patients. The indications for surgery were: 8 incidentalomas, 6 aldosterone-producing adenomas, 5 Cushing's adenomas, 3 phaeochromocytoma and 2 metastasis. Right adrenalectomy was performed on 11 patients, left on 11 and one was bilateral. Three cases required open conversion. Respiratory tract infection and hypertensive crisis were the postoperative complications. There was no mortality. The mean operative time was 125 minutes (range, 70-265). The mean size of adrenals excised was 6.5 cm (range, 4-14). The mean size of tumours excised was 4.6 cm (range, 1.5-12). The mean hospital stay was 3.5 days (range, 2-11). CONCLUSIONS: Laparoscopic adrenalectomy is a safe, reproducible and effective procedure with low complication rates, and well tolerated by the patients. The operating time and the length of hospital stay have decreased with the confidence of the technique.