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.

The impact of hereditary colorectal cancer on the Indian population.

INTRODUTION: The incidence of colorectal cancer in India is lower compared to the Western world. In Western countries, most cases of colorectal cancer are sporadic and the hereditary variety accounts for only 10-15% of all cases. The aim of the present review is to determine the clinical and epidemiological characteristics of hereditary colorectal cancer in India. MATERIALS AND METHODS: A Medline search was conducted to review the literature published from India regarding colorectal cancer. The keywords used included India, colorectal cancer, hereditary nonpolyposis, and familial adenomatous polyposis. All relevant articles were reviewed and the characteristic features of this disease in Indian population were collated and presented. RESULTS: Literature search revealed eighty two articles pertinent to India, of which only ten articles had relevant information on hereditary cancers. Although the overall incidence of colorectal cancer was low in both genders, there were a high proportion of patients developing colorectal cancer before the age of 45 years. Additionally, there was a higher proportion (10-15%) of hereditary nonpolyposis colorectal cancer cases, as confirmed by microsatellite instability. CONCLUSION: The overall incidence of colorectal cancer is low in India. There is a tendency to affect a relatively younger age group, and we infer that the incidence of hereditary colorectal cancer is high and is similar to the Western countries.

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.

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.

Sentinel lymph node biopsy in gastrointestinal malignancies-where do we stand?

Sentinel lymph nodes (SLNs) are the nodes in direct communication with the primary tumor and are therefore the first group of nodes to be involved in lymphatic metastasis. Though the role of SLN biopsy is well established in cancers of the breast and melanoma, its role in gastrointestinal malignancies is still evolving and controversial. In this paper, the literature is reviewed with respect to the status of SLN biopsy in gastrointestinal malignancies.

Evaluating the vascularity of intestinal anastomoses--can narrow band imaging play a role?

A variety of factors are critical for the success of bowel anastomoses. The most crucial patient factor is adequate vascularity of the bowel ends which are to be anastomosed. Currently, intraoperative features such as healthy looking bleeding edges of the bowel are considered to be signs of adequate vascular supply. However, once the anastomosis is performed, external appearances may not be reliable. In order to improve evaluation of the bowel as well as the anastomosis, our group has adopted the routine use of post-anastomosis intraoperative colonoscopy. Intraoperative colonoscopy provides vital information regarding the integrity of the anastomosis (leak testing) and also visualizes the mucosa of the bowel. Narrow Band Imaging (NBI) is a novel real-time imaging technique which is an integral component of many modern colonoscopes. We hypothesize that NBI assessment of vascularity at the time of intestinal anastomosis can improve safety and reduce the risks of anastomotic complications following surgery.

Does pancreatic ductal anatomy play a role in determining outcomes of pancreatic anastomoses?

Pancreatoduodenectomy (PD) is the surgical procedure performed for cancers of the head of the pancreas. Despite a substantial reduction in mortality rates following PD, morbidity remains high secondary to major post-operative complications. Post-operative pancreatic fistula (POPF), the commonest major complication following PD, results from the failure of the pancreato-enteric anastomosis. There appears to be a correlation between intrinsic pancreatic features like the texture of the gland and duct size and the outcome of the pancreatic anastomosis. Based on current clinical research data, we propose a new hypothesis called the "pancreatic ductal anatomy" concept. We hypothesize that morphological variations, anomalies or aberrations of the main pancreatic duct play a role in the outcome of the pancreatic anastomosis, irrespective of its type. The consequence of aberrant ductal anatomy is that certain areas of the remnant pancreas remain either undrained or partially drained, or have blocked ductules/ducts. This results in localized obstructive pancreatitis causing an inflammatory reaction which jeopardizes the anastomosis. We also propose two maneuvers which could possibly play a role in predicting potential problems and also planning the surgical resection and reconstruction in order to reduce the incidence of POPF. The first modality is the use of pre-operative magnetic resonance imaging (MRI) of the pancreatic duct, and the second maneuver is the gentle cannulation test of the pancreatic duct with a soft, narrow tube following transection of the pancreatic neck. These factors would alert the surgeon about potential ductal variations and could facilitate the surgical approach.

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.

Decision making in primary sacral tumors.

BACKGROUND CONTEXT: Primary tumors of the sacrum are extremely rare lesions. Their management is governed by an interplay of complex factors. Appropriate decision making is crucial to obtain the best possible outcome in terms of maximizing disease control while attempting to minimize neurological dysfunction. PURPOSE: Our study presents the results of a group of patients with primary tumors of the sacrum who were surgically treated by the same multidisciplinary team at a specialist oncology center over a relatively short period of time (5 years). STUDY DESIGN/SETTING: Patients were identified by a retrospective review from a prospectively maintained database. PATIENT SAMPLE: Between January 2000 and December 2005, 17 primary sacral tumors were surgically treated at our institution, a referral center for oncology. OUTCOME MEASURES: We evaluated the outcome in terms of local disease control, residual neurological dysfunction, and complications as a result of surgical intervention. METHODS: There were 12 males and 5 females. The diagnosis included chordoma in six patients, giant cell tumor in seven patients, aneurysmal bone cyst in two patients, and a chondrosarcoma and an osteoblastoma in one patient each. Sixteen of these patients were analyzed. Four lesions had their upper extent at S1, six lesions had their upper extent at S2, four lesions had their upper extent at S3, and two lesions were below S3. Ten cases were treated with wide excision and underwent partial sacral amputations. Five cases had a midline sacral amputation through S1, three through S2, and two through S3. Six benign lesions were treated with curettage. None of the patients received chemotherapy. Four cases received postoperative radiation. The follow-up duration ranged from 18 to 44 months with a mean of 31 months. RESULTS: None of the six patients who presented with loss of bladder and bowel control regained it after surgery. Of the 10 patients who had intact bladder and bowel control preoperatively only 4 retained bladder and bowel control postoperatively. Of the six patients who lost bladder and bowel control postoperatively, four patients had a wide excision where bilateral S2 roots were sacrificed. The other two cases in whom the disease extended up to S1 had curettage. Local recurrence occurred in 4 of the 10 lesions treated with wide excision. All the patients who had inadequate margins recurred. Local recurrence occurred in two of the six lesions treated with curettage. Three of the four cases who received postoperative irradiation developed recurrence. Our wound complication rate was 13%. CONCLUSION: Wide resection with adequate margins gives the best chance of local control and should be the surgery of choice for all malignant primary sacral tumors and in benign lesions involving lower segments when preservation of both S3 roots is possible. Intralesional curettage has a higher risk of local recurrence without providing the certainty of retaining neurological function. To retain bladder and bowel control and minimize neurological dysfunction, it may be worthwhile managing benign sacral tumors that extend above S3 with serial embolization. The administration of parenteral bisphosphonates may prove beneficial in cases of giant cell tumor managed with serial embolization.

Revision surgery for incidental gallbladder cancer: factors influencing operability and further evidence for T1b tumours.

BACKGROUND AND AIM: There is a need to increase the available data on revision radical surgery for incidental gallbladder cancer and to determine factors influencing operability. We aimed to assess the impact of stage of disease (pT) and the type of primary surgery (laparoscopy versus open) on resectability rates. MATERIAL AND METHODS: The data of 90 consecutive patients referred to the Tata Memorial Hospital between 1 January 2003 and 30 April 2007 for revision radical surgery for incidental gallbladder cancer were reviewed retrospectively. RESULTS: Of the 90 patients who underwent revision surgery, accurate data on T-stage was available in 76, and of these 76 patients, 44 (57.8%) had prior laparoscopic simple cholecystectomy, while 32 (42.2%) had undergone open surgery. The median time interval between the two surgeries was 2 months (range 4 weeks to 11 months). By T-stage, 23 patients had T1b disease, while 33 and 20 patients had T2 and T3 disease, respectively. Successful revision surgery could be undertaken in 71% of patients (54/76) and 29.6% of these had residual disease confirmed by histopathological examination. CONCLUSIONS: T-stage is an important factor in determining operability as confirmed by our study. As the T-stage of the disease increased, the chances of finding residual disease increased, while operability decreased. Furthermore, the case for revision surgery is strengthened because the incidence of lymph nodal disease is high even for pT1b cancers. The type of primary surgery does not affect operability in patients undergoing revision radical surgery for incidental gallbladder cancer.

Simultaneous gallbladder and bile duct cancers: revisiting the pathological possibilities.

The pathogenesis of gallbladder cancer presenting synchronously with malignancy of the bile duct has not been clearly understood. The possible causes for the simultaneous presence of these tumors could be due to local spread, metastases, de novo multifocal origin, or as part of a field change in the extrahepatic biliary apparatus. In this article, we discuss the cases of four patients with simultaneous gallbladder and bile duct malignancies and analyze their individual pathologies to provide an explanation into the mechanisms that may play a role in such conditions.

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.