A prospective trial evaluating the clinical performance of a novel surgical energy device in laparoscopic colon surgery.

INTRODUCTION: The aim of this prospective human trial was to evaluate the clinical performance of a novel THUNDERBEAT (TB) energy device in laparoscopic colon surgery. This study reports the first human trial in USA with this combined energy device in colon surgery. METHODS AND PROCEDURES: This is a prospective pilot study with 30 subjects undergoing left or right laparoscopic colon resection for neoplasm in a single institution. All soft tissue dissections and all vessel ligations were performed using TB. No other energy device was used within the abdomen. Recorded end-points were dissection time (from the start of colon mobilization to specimen removal), surgical procedure time, the number of times TB taken out of the abdominal cavity, intraoperative complications (bleeding at the time of mesenteric dissection or vessel ligation, thermal injury during surgery, injury of other organs), technical device problems, postoperative complications (bleeding, delayed thermal injuries, other complications within 30 days), length of hospital stay, and mortality. RESULTS: Thirty subjects (15 males) were enrolled in the study with median age and range 68.5 (21-86) and BMI kg/m(2) 25.5 (20-35). Twelve subjects underwent right and 18 left laparoscopic hemicolectomy. The mean surgical procedure time was 163 ± 86 min and for dissection using TB device 80.6 ± 35 min. Major vessel ligation was successful in all subjects. The median number of TB applications to seal inferior mesenteric artery was 3 (2-8). TB was taken out of the abdominal cavity during dissection for tip cleaning a medium number of two times/per case. No intraoperative or postoperative complications (bleeding, thermal injuries, etc.) related to use of TB were noted. CONCLUSIONS: The TB device demonstrated efficient and successful performance at tissue dissection and vessel ligation in left and right colectomies. TB technology can be employed in complex abdominal surgery and may save time through faster dissection but comparative studies with other energy devices are needed to confirm this.

Escalated radiation dose alone vs. concurrent chemoradiation for locally advanced and unresectable rectal cancers: results from phase II randomized study.

PURPOSE: This trial was undertaken to compare the rates of resectability between patients treated with neoadjuvant concurrent chemoradiation vs. boosted radiotherapy alone. MATERIALS AND METHODS: Patients with clinically unresectable rectal cancer were randomized to receive external beam radiation therapy (EBRT) to pelvis (45 Gy) with concurrent oral Capecitabine (CRT group; Arm 1) or EBRT to pelvis (45 Gy) alone followed by 20 Gy dose of localized radiotherapy boost to the primary tumor site (RT with boost group, Arm 2). All patients were assessed for resectability after 6 weeks by clinical examination and by CT scan and those deemed resectable underwent surgery. RESULTS: A total of 90 patients were randomized, 46 to Arm 1 and 44 to Arm 2. Eighty seven patients (44 in Arm 1 and 41 in Arm 2) completed the prescribed treatment protocol. Overall resectability rate was low in both the groups; R0 resection was achieved in 20 (43 %) patients in Arm 1 vs. 15 (34 %) in Arm 2. Adverse factors that significantly affected the resectability rate in both the groups were extension of tumor to pelvic bones and signet ring cell pathology. Complete pathological response was seen in 7 and 11 %, respectively. There was greater morbidity such as wound infection and delayed wound healing in Arm 2 (16 vs. 40 %; p = 0.03). CONCLUSION: Escalated radiation dose without chemotherapy does not achieve higher complete (R0) tumor resectability in locally advanced inoperable rectal cancers, compared to concurrent chemoradiation.

Experience of a specialist centre in the management of anastomotic sinus following leaks after low rectal or ileal pouch-anal anastomosis with diverting stoma.

AIM: The natural history and appropriate management of anastomotic sinus has not been clearly defined. The aim of this study was to evaluate the incidence, management and outcomes of anastomotic sinus. METHOD: The medical records of all patients who underwent a low anterior resection (LAR) or an ileal pouch-anal anastomosis (IPAA) with a diverting loop ileostomy (LI) and with contrast enema performed before planned stoma closure between 2001 and 2011 were retrospectively reviewed. The radiological features of the sinus tract, treatment and outcome of anastomotic sinus were studied. RESULTS: Twenty patients (8.2%) were found to have anastomotic sinuses out of the total of 244 patients who had undergone LAR (n = 146) or IPAA (n = 98) with LI. Of these, 13 (65%) had prior symptomatic leaks, while seven did not. Twelve patients (60%) were found to have simple sinus tracts, while eight had complex sinuses (associated with either pelvic cavities or severe strictures). Five patients with simple tracts were treated with observation alone. Fifteen patients underwent surgical interventions. Overall, with a median follow-up of 28 (6-73) months, 16 patients (80%) had resolution of their sinuses. All of 12 patients (100%) with simple sinus tracts and four of eight patients (50%) with complex sinuses underwent successful stoma reversals after 8 (3.5-24) months following the initial surgery (P = 0.01). CONCLUSION: Patients with simple tracts are significantly more likely to have complete resolution of sinuses than patients with complex sinuses. Persistent sinus associated with either a pelvic cavity or severe stricture despite surgical intervention is likely to lead to a permanent stoma.

A cystic hepatic lesion: when to worry?

A 16-year old female presented to hospital with abdominal pain. Features on computed tomography raised the possibility of biliary cystadenoma or cystadenocarcinoma. She underwent a liver resection, and histopathology confirmed a serous biliary cystadenoma. This case is presented to highlight the radiological features of this uncommon pre-malignant condition as well as to summarize a management algorithm for cystic liver lesions.

Application of Six Sigma towards improving surgical outcomes.

BACKGROUND/AIMS: Six Sigma is a 'process excellence' tool targeting continuous improvement achieved by providing a methodology for improving key steps of a process. It is ripe for application into health care since almost all health care processes require a near-zero tolerance for mistakes. The aim of this study is to apply the Six Sigma methodology into a clinical surgical process and to assess the improvement (if any) in the outcomes and patient care. METHODOLOGY: The guiding principles of Six Sigma, namely DMAIC (Define, Measure, Analyze, Improve, Control), were used to analyze the impact of double stapling technique (DST) towards improving sphincter preservation rates for rectal cancer. RESULTS: The analysis using the Six Sigma methodology revealed a Sigma score of 2.10 in relation to successful sphincter preservation. This score demonstrates an improvement over the previous technique (73% over previous 54%). CONCLUSIONS: This study represents one of the first clinical applications of Six Sigma in the surgical field. By understanding, accepting, and applying the principles of Six Sigma, we have an opportunity to transfer a very successful management philosophy to facilitate the identification of key steps that can improve outcomes and ultimately patient safety and the quality of surgical care provided.

Modification in the technique of pancreaticoduodenectomy: supracolic division of jejunum to facilitate uncinate process dissection.

Pancreaticoduodenectomy remains the recommended procedure for periampullary and pancreatic head tumors. The dissection of the uncinate process from the superior mesenteric vessels is a key step in this surgery. We describe a modification in the existing practice of infracolic division of the jejunum in order to facilitate this step. In this modification, the duodenojejunal (DJ) flexure and the proximal jejunum are delivered into the supracolic compartment and then the jejunum is divided. This exposes the uncinate process completely and facilitates the separation from the Superior Mesenteric Artery (SMA) and the Superior Mesenteric Vein (SMV). We have successfully employed this modified technique for 33 resections since February 2004. This modification of dividing the jejunum in the supracolic compartment is based on sound anatomic and embryologic grounds. It helps in aligning the uncinate process with the jejunal mesentery thereby making the dissection of uncinate process from the superior mesenteric vessels safe and complete.

Laparoscopy in pancreatic tumors.

Recently, increasing number of manuscripts - original articles and case reports have attempted to provide evidence of the forays of minimal access surgery into pancreatic diseases. Many, based on the lack of Level I evidence, still believe that laparoscopy in pancreatic surgery is experimental. This article attempts to look into data exploring the existing use of minimally invasive surgery in pancreatic disease to answer a vital question - what does the evidence say on the current status of laparoscopic surgery in pancreatic tumors.