ABSTRACT
BACKGROUND: Upfront primary tumor resection (PTR) has been associated with longer overall survival (OS) in patients with synchronous unresectable metastatic colorectal cancer (mCRC) in retrospective analyses. The aim of the CAIRO4 study was to investigate whether the addition of upfront PTR to systemic therapy resulted in a survival benefit in patients with synchronous mCRC without severe symptoms of their primary tumor. PATIENTS AND METHODS: This randomized phase III trial was conducted in 45 hospitals in The Netherlands and Denmark. Eligibility criteria included previously untreated mCRC, unresectable metastases, and no severe symptoms of the primary tumor. Patients were randomized (1 : 1) to upfront PTR followed by systemic therapy or systemic therapy without upfront PTR. Systemic therapy consisted of first-line fluoropyrimidine-based chemotherapy with bevacizumab in both arms. Primary endpoint was OS in the intention-to-treat population. The study was registered at ClinicalTrials.gov, NCT01606098. RESULTS: Between August 2012 and February 2021, 206 patients were randomized. In the intention-to-treat analysis, 204 patients were included (n = 103 without upfront PTR, n = 101 with upfront PTR) of whom 116 were men (57%) with median age of 65 years (interquartile range 59-71 years). Median follow-up was 69.4 months. Median OS in the arm without upfront PTR was 18.3 months (95% confidence interval 16.0-22.2 months) compared with 20.1 months (95% confidence interval 17.0-25.1 months) in the upfront PTR arm (P = 0.32). The number of grade 3-4 events was 71 (72%) in the arm without upfront PTR and 61 (65%) in the upfront PTR arm (P = 0.33). Three deaths (3%) possibly related to treatment were reported in the arm without upfront PTR and four (4%) in the upfront PTR arm. CONCLUSIONS: Addition of upfront PTR to palliative systemic therapy in patients with synchronous mCRC without severe symptoms of the primary tumor does not result in a survival benefit. This practice should no longer be considered standard of care.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols , Colorectal Neoplasms , Humans , Male , Colorectal Neoplasms/pathology , Colorectal Neoplasms/drug therapy , Colorectal Neoplasms/surgery , Colorectal Neoplasms/mortality , Female , Aged , Middle Aged , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Denmark/epidemiology , Netherlands/epidemiology , Bevacizumab/administration & dosage , Bevacizumab/therapeutic use , Neoplasms, Multiple Primary/surgery , Neoplasms, Multiple Primary/pathology , Neoplasms, Multiple Primary/drug therapy , Neoplasms, Multiple Primary/mortality , Aged, 80 and over , Adult , Neoplasm Metastasis , Survival RateABSTRACT
BACKGROUND: It is assumed that conventional laparoscopy (LAP) and robotic-assisted laparoscopic surgery (RALS) differ in terms of the surgeon's comfort. This study compared muscle workload, work posture and perceived physical exertion of surgeons performing LAP or RALS. METHODS: Colorectal surgeons with experience in advanced LAP and RALS performed one of each operation. Bipolar surface electromyography (EMG) recordings were made from forearm, shoulder and neck muscles, and expressed relative to EMG maximum (%EMGmax ). The static, median and peak levels of muscle activity were calculated, and an exposure variation analysis undertaken. Postural observations were carried out every 10 min, and ratings of perceived physical exertion before and after surgery were recorded. RESULTS: The study included 13 surgeons. Surgeons performing LAP showed higher static, median, and peak forearm muscle activity than those undertaking RALS. Muscle activity at peak level was higher during RALS than LAP. Exposure variation analysis demonstrated long-lasting periods of low-level intensity muscle activity in the shoulders for LAP, in the forearms for RALS, and in the neck for both procedures. Postural observations revealed a greater need for a change in work posture when performing LAP compared with RALS. Perceived physical exertion was no different between the surgical modalities. CONCLUSION: Minimally invasive surgery requires long-term static muscle activity with a high physical workload for surgeons. RALS is less demanding on posture.
ANTECEDENTES: Se asume que la cirugía laparoscópica (laparoscopic, LAP) y la cirugía laparoscópica asistida por robot (robotic-assisted laparoscopic surgery, RALS) difieren en cuanto a la comodidad del cirujano. En este estudio se comparó la carga de trabajo muscular, la postura de trabajo y el esfuerzo físico percibido por los cirujanos al realizar LAP o RALS. MÉTODOS: Trece cirujanos colorrectales con experiencia en LAP avanzada y RALS realizaron una operación con cada uno de los abordajes. Se registró la electromiografía de superficie bipolar en los músculos del antebrazo, del hombro y del cuello, y se expresó en relación con el EMG máximo (% EMGmax). Se calculó el nivel de actividad muscular estático, mediano y pico, y se realizó un análisis de variación de la exposición. Las observaciones posturales se llevaron a cabo cada diez minutos y se registraron las valoraciones del esfuerzo físico percibido antes y después de la cirugía. RESULTADOS: La práctica de LAP mostró una mayor actividad muscular estática, mediana y pico del antebrazo en comparación con la práctica de RALS. El hombro izquierdo mostró la mayor actividad muscular en RALS a nivel máximo. El análisis de variación de exposición demostró periodos prolongados de actividad muscular de baja intensidad para LAP en los hombros, para RALS en los antebrazos y para ambos en el cuello. Las observaciones posturales mostraron una mayor necesidad de un cambio en la postura de trabajo al realizar LAP en comparación con RALS. El esfuerzo físico percibido no fue diferente entre ambas modalidades quirúrgicas. CONCLUSIÓN: La cirugía mínimamente invasiva requiere una actividad muscular estática prolongada con una alta carga de trabajo físico para los cirujanos. RALS es menos exigente en el aspecto postural.
Subject(s)
Laparoscopy , Muscle, Skeletal/physiopathology , Physical Exertion , Posture , Robotic Surgical Procedures , Surgeons , Workload , Adult , Biomechanical Phenomena , Electromyography , Ergonomics , Female , Humans , Male , Middle AgedABSTRACT
BACKGROUND AND AIMS: Self-expanding metallic stents (SEMS) have since 1991 established themselves as an option in the treatment of large bowel obstruction. The aim of this study was to evaluate the use of SEMS in management of acute colorectal obstructions at a Danish Surgical Gastroenterology center. MATERIAL AND METHODS: Retrospective review of charts from all patients who, in the period Marts 2002 to December 2007 underwent insertion of a SEMS for an acute large bowel obstruction. RESULTS: Of 45 patients included, SEMS was intended as a bridge to surgery in 20 patients and as palliation in 25 patients. For malignant etiology, the SEMS procedure was a technical and clinical success in 97.4% of the cases. Complications occurred in 21%, mortality rate 2,6%. For benign etiology, the SEMS procedure was a technical success in 85.7%, and a clinical success in 71.4%. Complications occurred in 71.4% of the benign cases with a mortality rate of 28,6%. CONCLUSIONS: Placement of SEMS for acute large bowel obstruction with malignant etiology is an effective and safe procedure with low mortality and morbidity. However results for benign obstructions are questionable and more research is needed to determine the role of SEMS.
Subject(s)
Colorectal Neoplasms/pathology , Endoscopy , Intestinal Obstruction/pathology , Intestinal Obstruction/therapy , Stents , Acute Disease , Aged , Aged, 80 and over , Cohort Studies , Colorectal Neoplasms/surgery , Denmark , Equipment Design , Female , Humans , Intestinal Obstruction/etiology , Male , Middle Aged , Retrospective Studies , Treatment OutcomeABSTRACT
BACKGROUND: Trocar incisions are important sources of pain the first days after laparoscopic cholecystectomy. Radially expanding trocars may cause less pain than conventional cutting trocars. METHODS: In a patient- and observer-blinded trial, 80 patients were randomized to undergo laparoscopic cholecystectomy using either radially expanding trocars (radial group) or conventional cutting trocars (cutting group). Two 10-mm and two 5-mm trocars were used in both treatment groups. All the patients received standardized anesthetic and analgesic treatment. The primary outcome was incisional pain. Pain was registered during mobilization using a visual analog scale (VAS) and a verbal rating scale (VRS) before and 6 h after the operation, and at postoperative days 1 and 2. The needs for a fascial incision to retract the gallbladder, active surgical hemostasis, and supplementary requirements of opioids during the hospital stay were registered. In addition, 2 days after the operation, the incidence and severity of suggilations at the trocar incisions were measured. RESULTS: Data from 77 patients were available for statistical analysis. In the radial group, 23 patients needed fascial incision for gallbladder retraction compared with 11 patients in the cutting group (p = 0.006). No significant intergroup differences in VAS or VRS pain scores or any other variable were found. CONCLUSIONS: The use of radially expanding trocars has no effect on incisional pain after laparoscopic cholecystectomy.
Subject(s)
Cholecystectomy, Laparoscopic/adverse effects , Cholecystectomy, Laparoscopic/instrumentation , Gallbladder Diseases/surgery , Pain, Postoperative/etiology , Surgical Instruments/adverse effects , Adolescent , Adult , Aged , Equipment Design , Female , Follow-Up Studies , Humans , Length of Stay , Male , Middle Aged , Pain Measurement , Pain, Postoperative/diagnosis , Postoperative Hemorrhage/diagnosis , Postoperative Hemorrhage/etiologyABSTRACT
Acute pancreatitis is in the majority of patients a mild, self-limiting illness. Five to fifteen percent of the patients develop acute necrotizing pancreatitis, a severe illness with a high morbidity and mortality. Secondary infection of the pancreatic necrosis (infected pancreatic necrosis) is the main cause of death. Pancreatic necrosis is identified with a high accuracy by contrast-enhanced computed tomography. The differentiation between sterile and infected necrosis requires demonstration of bacteria or fungi isolated from the necrosis. Surgical treatment of a sterile necrosis remains controversial, but there is a tendency towards conservative non-operative treatment. Infected pancreatic necrosis is regarded as an absolute indication for surgery, untreated the mortality is approximately 100%. The aim of modern treatment is to remove the pancreatic necrosis continuously. This has successfully been done by the open packing method, with or without subsequent drainage. At present no randomized trials comparing the different treatment modalities are available. The question of prophylactic antibiotics still remains unanswered. For the present imipenem 0,5 g x 3 is recommended.
Subject(s)
Pancreatitis/pathology , Acute Disease , Humans , Necrosis , Pancreatitis/diagnosis , Pancreatitis/surgery , PrognosisABSTRACT
This paper reflects the problems in having a large non-specific waiting-list. One hundred and twenty-eight patients were on a waiting-list under the main diagnosis of prostatism. This diagnosis revealed seven patients with cancer in the urinary tract system. Only two-thirds of the patients on the waiting-list were interested in further examination and treatment. This paper emphasizes the need for a more specific referral, when dealing with symptoms from the lower urinary tract system.
Subject(s)
Prostatic Hyperplasia/diagnosis , Referral and Consultation , Urination Disorders/diagnosis , Waiting Lists , Denmark , Humans , Male , Prostatic Hyperplasia/therapy , Prostatic Neoplasms/diagnosis , Prostatic Neoplasms/therapy , Urination Disorders/therapyABSTRACT
Early graft occlusion after coronary artery bypass grafting may have deleterious consequences. We routinely use transit-time flowmetry after termination of cardiopulmonary bypass, and we report five cases of early graft failure detected by the flowmeter. Electrocardiographic (ECG) changes were seen in only one of these five cases, and none of the patients had low cardiac output or other signs of graft failure at the end of the operation. The cause of graft failure was tagging in one case, rotation of internal mammary artery grafts in two and kinking of vein grafts in two cases. All errors were corrected, and control flowmetry showed normal flow rates after correction. Flowmetry takes less than 10 min, even with multiple bypass grafts. Based on our results, we advocate routine quality control with flowmetry after termination of cardiopulmonary bypass, since ECG changes are insufficient as checks of flow in bypass grafts.
Subject(s)
Coronary Artery Bypass/adverse effects , Graft Occlusion, Vascular/etiology , Aged , Blood Flow Velocity , Electrocardiography , Female , Graft Occlusion, Vascular/diagnostic imaging , Humans , Male , Middle Aged , Prospective Studies , Rheology/methods , UltrasonographyABSTRACT
OBJECTIVES: To determine the value of PTFE grafts with a distal vein cuff as a conduit for below-knee (BK) popliteal and distal bypass in the absence of autologous vein. DESIGN: Retrospective study. MATERIALS AND METHODS: Forty below BK popliteal and distal bypass procedures in 39 patients with PTFE and distal vein cuff (Miller cuff n = 31, Wolfe cuff and adjuvant arteriovenous fistula n = 9). Nineteen primary and 21 secondary reconstruction procedures. RESULTS: The primary patency rate was 62.5% at 1 year falling to 50% at 2 years. The secondary patency rates were very similar owing to poor outcome of thrombectomy. Ten cases (25%) resulted in major amputation postoperatively. There was a tendency towards better outcome for primary procedures compared to secondary/redo procedures. CONCLUSIONS: BK popliteal and distal bypass with PTFE and distal vein cuff is a worthwhile procedure in the absence of autologous vein. The value of thrombectomy following thrombosis of a secondary bypass procedure with PTFE and distal vein cuff is questionable.