An Early Prospective Clinical Study to Evaluate the Safety and Performance of the Versius Surgical System in Robot-Assisted Cholecystectomy.

OBJECTIVE: The aim of this study was to demonstrate the ability of the Versius Surgical System to successfully and safely complete cholecystectomy. BACKGROUND: The system has been developed in-line with surgeon feedback to overcome limitations of conventional laparoscopy to enhance surgeon experience and patient outcomes. Here we present results from the cholecystectomy cohort from a completed early clinical trial, which was designed to broadly align with Stage 2b of the Idea, Development, Exploration, Assessment, Long-term follow-up framework for surgical innovation. METHODS: Procedures were performed between March 2019 and September 2020 by surgical teams consisting of a lead surgeon and operating room (OR) assistants. Male or female patients aged 18 years and over and requiring cholecystectomy were enrolled. The primary endpoint was the rate of unplanned conversion from robot-assisted surgery to conventional laparoscopic or open surgery. Adverse events (AEs) and serious AEs were adjudicated by video review of the surgery and patient study reports by an independent Clinical Expert Committee. RESULTS: Overall, 134/143 (93.7%) cholecystectomies were successfully completed using the device. Of the 9 (6.3%) conversions to another surgical modality, 7 were deemed to be related to the device. A total of 6 serious AEs and 3 AEs occurred in 8 patients (5.6%), resulting in 4 (2.8%) readmissions to hospital within 30 days of surgery and 1 death. CONCLUSIONS: This study demonstrates cholecystectomy performed using the device is as safe and effective as conventional laparoscopy and supports the implementation of the device on a wider scale, pending instrument modifications, in alignment with Idea, Development, Exploration, Assessment, Long-term follow-up Stage 3 (Assessment).

Laparoscopic management of intra-hepatic gallbladder perforation.

Intra-hepatic perforation of the gallbladder (GB) leading to hepatic abscess is a serious and rare complication of cholecystitis, with very few sporadically reported cases in the literature. Hence, there is no standard approach to treat it. A thorough radiological evaluation with computed tomography and endoscopic retrograde cholangiopancreatography is necessary before proceeding with surgery in such cases. An early laparoscopic intervention to perform a sub-total cholecystectomy with drain placement is enough to treat both cholecystitis and liver abscess in a definitive manner. While previous reports have advocated an open surgery, our series demonstrates that early laparoscopic management is a safe and suitable approach in such cases.

Cronkhite Canada syndrome complicated by pulmonary embolism-A case report.

INTRODUCTION: Cronkhite Canada Syndrome (CCS) is a rare syndrome, described in 1955 by Americans, Leonard Wolsey Cronkhite and Wilma Jeanne Canada in the New England Journal of Medicine [1]. About 450 cases have been reported. Complications, like malignant transformation, unprovoked thromboembolism is known. Since there is wide variability in medical presentation, no definitive diagnostic and treatment protocol s have been set. The mortality remains at 55%. CASE PRESENTATION: We report a case of a 50 year old male patient presenting with diarrhea, weight loss, abdominal pain, ectodermal features. His upper (UGI) and lower Gastrointestinal (LGI) endoscopy showed multiple polypoidal and carpet like lesions in fundus, body and antrum of stomach. Videocolonoscopy showed multiple sessile and pedunculated polyps. Multiple biopsies were taken, proving malignancy. Because of poor nutrition, total parenteral nutrition was given for four weeks. After nutritional optimization, he underwent laparoscopic assisted subtotal colectomy. His post-operative course was complicated by the occurrence of pulmonary embolism and anastomotic leak. DISCUSSION: CCS is an ailment of unknown pathophysiology. Considering what is known so far, patients suffering from CCS are at highest risk of thromboembolic episodes. This seems to be irrespective of surgical intervention. Patients of CCS should have thromboembolic prophylaxis started as soon as a diagnosis is made. They should have thrombophilia profile, fibrinogen level and Factor 8 tested before any intervention is planned. CONCLUSION: If CCS presents with a surgical indication, namely malignancy, the patient should be categorized as highest risk for thromboembolic complications and both mechanical and pharmacological prophylaxis be instituted.

Per rectal endoscopic myotomy for the treatment of adult Hirschsprung's disease: First human case (with video).

Hirschsprung's disease (HD) is a congenital disorder characterized by the absence of intrinsic ganglion cells in submucosal and myenteric plexuses of the hindgut; and presents with constipation, intestinal obstruction and/or megacolon. HD commonly involves the rectosigmoid region (short segment HD), although shorter and longer variants of the disease are described. Standard treatment involves pull-through surgery for short segment HD or posterior anorectal myotomy in selected ultrashort segment candidates. Third space endoscopy has evolved during the past few years. Per oral endoscopic myotomy and per oral pyloromyotomy are described for treatment of achalasia cardia and refractory gastroparesis, respectively. Using the same philosophy of muscle/sphincter disruption for spastic bowel segments, per rectal endoscopic myotomy could be considered as a treatment option for short segment HD. A 24-year-old male patient presented with refractory constipation since childhood, and habituated to high-dose laxative combinations. Diagnosis was confirmed as adult short segment HD by barium enema, colonoscopic deep suction mucosal biopsies and anorectal manometry. Histopathology confirmed aganglionosis in the distal 15 cm. By implementing principles of third space endoscopy, per rectal endoscopic myotomy 20 cm in length was successfully carried out. At 24-week follow up, the patient reported significant relief of constipation and associated symptoms. Sigmoidoscopy, anorectal manometry and barium enema confirm improved rectal distensibility and reduced rectal pressures. The present case report describes the first human experience of per rectal endoscopic myotomy for successful treatment of adult short segment HD.

Laparoscopy-assisted continuous ambulatory peritoneal dialysis catheter placement using Amplatz dilators: a new technique with results.

OBJECTIVE: To describe a new modified technique of laparoscopic placement of continuous ambulatory peritoneal dialysis (CAPD) catheters and assess the early results. METHODS: CAPD catheter implantation was performed in 100 consecutive patients. The technique used laparoscopically guided, extraperitoneal tunneling of the CAPD catheter using Amplatz dilators. The extraperitoneal tunneling helped to maintain the catheter's orientation toward the deep pelvis. Omentopexy was performed on patients with long omentum. Wherever indicated, adhesiolysis was performed to eliminate compartmentalization that could affect the completeness of dialyzate drainage. The average duration of surgery, hospital stay, morbidity, mortality, and catheter survival were assessed. RESULTS: The average operative time was 40 ± 7 minutes, and hospital stay was 3 ± 1 days. There were no conversions from laparoscopy to conventional catheter insertion methods. Exit site or tunnel infections, hemorrhagic complications, abdominal wall hernias, or catheter cuff extrusions were not detected. No patient had either catheter migration or displacement. Peroperative mortality did not occur in this series of patients. Catheter survival was 97% at 6 months. CONCLUSION: The laparoscopic method described in this report is compliant with consensus guidelines for the best demonstrated practices in peritoneal access placement. Laparoscopy permits direct visualization of all procedure steps in a safe, efficient, and reproducible manner. The use of Amplatz dilators helps in better orientation of the catheter reducing the risk of catheter tip migration.

Long term outcome and prognostic factors for large hepatocellular carcinoma (10 cm or more) after surgical resection.

BACKGROUND: Surgical resection is the standard treatment for hepatocellular carcinoma (HCC). However, the role of surgery in treatment of large tumors (10 cm or more) is controversial. We have analyzed, in a single centre, the long-term outcome associated with surgical resection in patients with such large tumors. METHODS: We retrospectively investigated 166 patients who had undergone surgical resection between July 1995 and December 2006 because of large (10 cm or more) HCC. Survival analysis was done using the Kaplan-Meier method. Prognostic factors were evaluated using univariate and multivariate analyses. RESULTS: Of the 166 patients evaluated, 80% were associated with viral hepatitis and 48.2% had cirrhosis. The majority of patients underwent a major hepatectomy (48.2% had four or more segments resected and 9% had additional organ resection). The postoperative mortality was 3%. The median survival in our study was 20 months, with an actuarial 5-year and 10-year overall survival of 28.6% and 25.6%, respectively. Of these patients, 60% had additional treatment in the form of transarterial chemoembolization, radiofrequency ablation or both. On multivariate analysis, vascular invasion (P < 0.001), cirrhosis (P = 0.028), and satellite lesions/multicentricity (P = 0.006) were significant prognostic factors influencing survival. The patients who had none of these three risk factors had 5-year and 10-year overall survivals of 57.7% each, compared with 22.5% and 19.3%, respectively, for those with at least one risk factor (P < 0.001). CONCLUSIONS: Surgical resection for those with large HCC can be safely performed with a reasonable long-term survival. For tumors with poor prognostic factors, there is a pressing need for effective adjuvant therapy.

Pre-transplant optimization by Molecular Adsorbent Recirculating System in patients with severely decompensated chronic liver disease.

BACKGROUND: The outcome of liver transplantation (LT) is influenced by the recipient's clinical condition. In a retrospective observational study, we evaluated the role of pre-LT Molecular Adsorbent Recirculating System (MARS) treatment in improving the clinical status and thereby the outcome of patients with chronic liver disease and severe hepatic decompensation. METHODS: Between March 2002 and September 2006, 70 patients with end-stage chronic liver disease underwent living-donor LT (LDLT). Of these, 9 (13%) patients with severely decompensated liver function (serum bilirubin> 350 micromol/L [20 mg/dL] and/or hepatic encephalopathy > or = grade 2) received pre-LT MARS treatment. RESULTS: The median MELD score was 33 (range, 26-47). A median of 2 (range, 1-6) sessions (8 hour/session) of MARS dialysis was performed per patient. MARS treatment was associated with reduction in serum bilirubin, creatinine and ammonia levels and no procedure-related complications. CONCLUSION: Pre-LT MARS is well tolerated and results in reduction of jaundice and improvement in renal function and may be useful in the management of patients with severe hepatic decompensation.

Clinical profile of carcinoma stomach at a tertiary care hospital in south India.

Carcinoma of the stomach is an important cause of mortality due to cancer. Carcinoma of the stomach is common in the southern region of India. We conducted a retrospective study on the epidemiological, clinical and survival patterns among the patients with carcinoma of the stomach, attending our hospital from June 19, 1995 to 1st January 2003. All the patients had histopathological confirmation of malignancy. Patients with gastrooesophageal junction lesions were excluded. Surgery was performed with curative as well as palliative intent in suitable patients. Chemotherapy has been incorporated in to the combined modality treatment in our hospital since July 2000. Postoperative chemotherapy comprised commonly used intravenous chemotherapy regimens, while oral chemotherapy (etoposide) was given to patients with disease not amenable to surgery, and those having poor performance and nutritional status. Oral etoposide was given in a dose of 50 mg/day for 14 days, in a 28 day cycle. Quality of life was assessed in the oral chemotherapy group. Out of the 1749 cancer patients seen during the period, 151 had gastric malignancy (8.6%). The median age was 55 years (range 15-84 years). The male to female ratio was 4:1. Adenocarcinoma was found in 148 patients, 2 had stromal tumours and 1 had non-Hodgkin lymphoma. Stage disribution was as follows; stage 2-1 patient , stage 3a-25, stage3b-49, stage4-3 1, Metastatic-28. Staging was not completed in 17 patients. Eighty-nine patients underwent surgery. Fifty-nine patients (39%) did not have surgery. One patient underwent polypectomy. Curative gastrectomy was performed in 11 patients. Thirty-nine patients underwent palliative tumour resection. Palliative gastro-jejunostomy for relief of symptoms was performed in 26 patients and exploratory laparotomy alone was perforaied in 13. Thirty-eight patients received chemotherapy. Out of these, only 2 patients had prior complete resection of the tumour and 36 received palliative chemotherapy. Intravenous chemotherapy was given to 17 patients and oral chemotherapy to 19; All the patients who received oral etoposide did not experience any toxicity. Patients who received intravenous chemotherapy (n=17) had the following toxicities: grade 3 emesis in 4 (20%), discoloration of the skin and nails in 6(31%), alopecia in 8 (50%), grade 3 diarrhoea in 3 (15%) and neutropenic fever in 4 patients (20%). Median survival for the cohort was 10.4 months. Quality of life parameters, such as sleep, appetite, weight, pain, work and general sense of ill health showed improvement. In conclusion, 8.6% of all cancers at our hospital were due to cancer of stomach, in whom distal gastric tumor were more frequent and most were non-resectable. Median survival was 10.4 months. Oral etoposide was found to be safe, improved the quality of life and may play a role in the palliative management of advanced carcinoma of the stomach.

Bouveret's syndrome--an unusual cause of spontaneous resolution of gastric outlet obstruction.

Gastric outlet obstruction due to a gallstone impacted in the duodenal bulb (Bouveret's syndrome) is a rare complication of gallstones. We report a 47-year-old man with this syndrome in whom the impacted stone migrated uneventfully.

Spontaneous perforation--a rare complication of choledochal cyst.

We report a 2-year-old girl with spontaneous perforation of choledochal cyst. Preoperative diagnosis was possible by hepatobiliary scintigraphy. In view of emergency presentation and bile peritonitis, management was a staged procedure with peritoneal lavage and T-tube drainage of the biliary system, followed by excision of the cyst and Roux-en-Y hepatico-jejunostomy 3 months later.

Morphological changes in bile ducts following preoperative biliary stenting.

OBJECTIVES: To analyze the morphological changes in bile ducts following endobiliary stent insertion, and consequent technical problems encountered at surgery. METHODS: Data on bile duct morphology--gross (luminal diameter and wall thickness) and microscopic (histological changes in bile duct wall graded semiquantitatively)--and operative parameters related to bile duct dissection (grade of difficulty in dissection) were collected prospectively in 31 consecutive patients undergoing pancreatico-duodenectomy. These data were compared between patients who had undergone preoperative endoscopic biliary stent placement (n=17) and those who had not (n=14). RESULTS: Mean duration of stenting before surgery was 34 (range 10-120) days. Stented ducts were significantly narrower (luminal diameter 9 [7-12] mm vs. 17.5 [8-23] mm; p=0.0001) and had thicker walls (2.3 [1.3-3.5] mm vs. 1.85 [0.8-2.2] mm; p=0.004) compared to non-stented ones. On microscopy, stented ducts had advanced grades of submucosal gland hypertrophy, fibrosis and inflammatory cell infiltrate. Difficulty in bile duct dissection was encountered more often in patients who had been stented than in those without stents, though the difference was not statistically significant. CONCLUSION: Endobiliary stent placement results in significant morphological and fibroproliferative inflammatory changes in bile ducts, making dissection difficult.

Acute mesenteric venous thrombosis complicating endoscopic variceal sclerotherapy with absolute alcohol.

We report two patients, one with liver cirrhosis and another with extrahepatic portal vein obstruction, who developed acute mesenteric vein thrombosis following endoscopic variceal sclerotherapy with absolute alcohol. Both patients recovered after emergency laparotomy and resection of gangrenous bowel loop.

Dieulafoy's lesion of duodenum: a case report.

BACKGROUND: Dieulafoy's lesion is an uncommon but important cause of recurrent upper gastrointestinal bleeding. Extragastric location of Dieulafoy's lesion is rare. We report two cases of Dieulafoy's lesion of the duodenum and discuss the management of this extremely uncommon entity. CASE PRESENTATION: Two cases of massive upper gastro-intestinal bleeding in young adults due to Dieulafoy's lesion of the duodenum are reported. Endoscopic diagnosis was possible in both cases. Hemostasis was achieved successfully by endoscopic adrenaline injection. The endoscopic appearance, pitfalls in the diagnosis and management of this rare lesion are discussed. CONCLUSIONS: Endoscopic diagnosis of extragastric Dieulafoy's lesion can be difficult because of the small size and obscure location of the lesion. Increased awareness and careful and early endoscopic evaluation following the bleeding episode are the key to accurate diagnosis. Adrenaline injection is one of the important endoscopic modalities for control of bleeding.

Longterm survival after extended resections in patients with gallbladder cancer.

BACKGROUND: Surgery is the treatment of choice for gallbladder cancer, but the extent of resection and its benefits remain unclear. STUDY DESIGN: Survival analysis of 42 patients who underwent extended resections for gallbladder cancer was performed. Resections were labeled R0 (curative) or R1 (noncurative) based on histopathologic evaluation. Survival curves were constructed using the Kaplan-Meier method, and survival data were analyzed by univariate and multivariate analyses to identify factors associated with longterm (>2 years) survival. RESULTS: R0 status was achieved in 18 patients (43%): 100%, 100%, 45%, and 0% in stages I, II, III, and IV, respectively. Patients with R0 resections had a significantly better survival than those with R1 resections (median 25.8 months versus 17.0 months; p = 0.03). R0 status was achieved in only 3 of 20 patients (15%) with node positive (N1) disease compared with 14 of 17 patients (82%) with node negative (N0) disease. Patients with N0 disease had a significantly better survival than those with N1 disease (median not reached versus 17 months; p = 0.01). None of the patients with N1 disease survived 5 years; 5-year survival for N0 patients was 58%. Adjuvant therapy did not have a significant effect on survival. CONCLUSIONS: In patients with gallbladder cancer, R0 status could be achieved in only 43% of patients undergoing extended resections. R0 status and N0 disease were associated with better longterm survival.

Large Brunneroma presenting with bleeding.

Brunner's gland adenoma (Brunneroma) is a rare entity. We report a patient who presented with severe anemia due to bleed from a large Brunneroma arising from the duodenal bulb, and was managed successfully by surgical excision of the tumor.

Early gallbladder cancer.

BACKGROUND: The majority of patients with gallbladder cancer (GBC) have advanced disease at the time of diagnosis and are unresectable. Longterm survival is usually seen in a subset of patients with early GBC (EGBC)-cancer confined to the mucosa (pT1a) and muscularis (pT1b). Management guidelines of EGBC are not yet defined and are controversial. The purpose of this article is to evaluate the diagnostic aspects and effects of resectional procedures on survival outcome in patients with EGBC. STUDY DESIGN: EGBC was defined as cancer confined to the mucosa (pT1a) or muscularis (pT1b) according to the TNM classification. Clinicopathological details and survival data of 14 patients who had EGBC were analyzed. There were 9 women and 5 men, with a mean age of 60 years. RESULTS: A definite preoperative diagnosis was possible in only three patients and three patients were diagnosed at operation; the majority of patients were diagnosed incidentally after cholecystectomy for associated gallstones. Two patients underwent extended cholecystectomy and 12 patients underwent simple cholecystectomy. Two patients had pT1a and 12 had pT1b lesions. Mean (SD) survival was 71.5 (12.2) months and median survival was 42 months. There were five treatment failures with locoregional recurrence and death; all with pT1b tumors were treated by simple cholecystectomy. Cumulative 1-, 3-, and 5-year survival was 92%, 68%, and 68% respectively [corrected]. CONCLUSIONS: Simple cholecystectomy is an adequate treatment only for mucosal GBC. Patients with pT1b tumors require extended cholecystectomy. Incidental GBC extending up to the muscularis merits early reoperation for completion of extended cholecystectomy, which offers the only chance of cure.