Role of eHealth application Oncokompas in supporting self-management of symptoms and health-related quality of life in cancer survivors: a randomised, controlled trial.

BACKGROUND: Knowledge about the efficacy of behavioural intervention technologies that can be used by cancer survivors independently from a health-care provider is scarce. We aimed to assess the efficacy, reach, and usage of Oncokompas, a web-based eHealth application that supports survivors in self-management by monitoring health-related quality of life (HRQOL) and cancer-generic and tumour-specific symptoms and obtaining tailored feedback with a personalised overview of supportive care options. METHODS: In this non-blinded, randomised, controlled trial, we recruited patients treated at 14 hospitals in the Netherlands for head and neck cancer, colorectal cancer, breast cancer, Hodgkin lymphoma, or non-Hodgkin lymphoma. Adult survivors (aged ≥18 years) were recruited through the Netherlands Cancer Registry (NCR) and invited by their treating physician through the Patient Reported Outcomes Following Initial Treatment and Long term Evaluation of Survivorship (PROFILES) registry. Participants were randomly assigned (1:1) by an independent researcher to the intervention group (access to Oncokompas) or control group (access to Oncokompas after 6 months), by use of block randomisation (block length of 68), stratified by tumour type. The primary outcome was patient activation (knowledge, skills, and confidence for self-management), assessed at baseline, post-intervention, and 3-month and 6-month follow-up. Linear mixed models (intention-to-treat) were used to assess group differences over time from baseline to 6-month follow-up. The trial is registered in the Netherlands Trial Register, NTR5774 and is completed. FINDINGS: Between Oct 12, 2016, and May 24, 2018, 625 (21%) of 2953 survivors assessed for eligibility were recruited and randomly assigned to the intervention (320) or control group (305). Median follow-up was 6 months (IQR 6-6). Patient activation was not significantly different between intervention and control group over time (difference at 6-month follow-up 1·7 [95% CI -0·8-4·1], p=0·41). INTERPRETATION: Oncokompas did not improve the amount of knowledge, skills, and confidence for self-management in cancer survivors. This study contributes to the evidence for the development of tailored strategies for development and implementation of behavioural intervention technologies among cancer survivors. FUNDING: Dutch Cancer Society (KWF Kankerbestrijding).

Laparoscopic versus open sigmoid resection for diverticular disease: follow-up assessment of the randomized control Sigma trial.

BACKGROUND: The short-term results of the Sigma trial show that laparoscopic sigmoid resection (LSR) used electively for diverticular disease offers advantages over open sigmoid resection (OSR). This study aimed to compare the overall mortality and morbidity rates after evaluation of the clinical outcomes at the 6-month follow-up evaluation. METHODS: In a prospective, multicenter, double-blind, parallel-arm, randomized control trial, eligible patients were randomized to either LSR or OSR. The short-term results and methodologic details have been published previously. Follow-up evaluation was performed at the outpatient clinic 6 weeks and 6 months after surgery. RESULTS: In this trial, 104 patients were randomized for either LSR or OSR, and the conversion rate was 19.2%. The LSR approach was associated with short-term benefits such as a 15.4% reduction in the major complications rate, less pain, and a shorter hospital stay at the cost of a longer operating time. At the 6-month follow-up evaluation, no significant differences in morbidity or mortality rates were found. Two patients died of cardiac causes (overall mortality, 3%). Late complications (7 LSR vs. 12 OSR; p = 0.205) consisted of three incisional hernias, five small bowel obstructions, four enterocutaneous fistulas, one intraabdominal abscess, one retained gauze, two anastomotic strictures, and three recurrent episodes of diverticulitis. Nine of these patients underwent additional surgical interventions. Consideration of the major morbidity over the total follow-up period (0-6 months) shows that the LSR patients experienced significantly fewer complications than the OSR patients (9 LSR vs. 23 OSR; p = 0.003). The Short Form-36 (SF-36) questionnaire showed significantly better quality of life for LSR at the 6-week follow-up assessment. However, at the 6-month follow-up assessment, these differences were decreased. CONCLUSIONS: The late clinical outcomes did not differ between LSR and OSR during the 30-day to 6-month follow-up period. Consideration of total postoperative morbidity shows a 27% reduction in major morbidity for patients undergoing laparoscopic surgery for diverticular disease.

Laparoscopic sigmoid resection for diverticulitis decreases major morbidity rates: a randomized control trial: short-term results of the Sigma Trial.

BACKGROUND: No randomized controlled trial has compared laparoscopic sigmoid resection (LSR) to open sigmoid resection (OSR) for symptomatic diverticulitis of the sigmoid colon. This study tested the hypothesis that LSR is associated with decreased postoperative complication rates as compared with OSR. METHODS: This was a prospective, multicenter, double-blind, parallel-arm, randomized controlled trial. Eligible patients were randomized to either LSR or OSR. Endpoints included postoperative mortality, and complications were classified as major and minor. The generator of the allocation sequence was separated from the executor. Blinding was ensured using an opaque wound dressing to cover the abdomen. Symptomatic diverticulitis of the sigmoid colon was defined as recurrent disease Hinchey I, IIa, IIb, symptomatic stricture, or severe rectal bleeding. The decision to discharge patients was made by independent physicians blind to the allocation sequence. Data were analyzed according to the intention to treat principle. RESULTS: From 2002 to 2006, 104 patients were randomized in 5 centers. All patients underwent the allocated intervention. Fifty-two LSR patients were comparable to 52 OSR patients for gender, age, BMI, ASA grade, comorbid conditions, previous abdominal surgery, and indication for surgery. LSR took longer (P = 0.0001) but caused less blood loss (P = 0.033). Conversion rate was 19.2%. Mortality rate was 1%. There were significantly more major complications in OSR patients (9.6% vs. 25.0%; P = 0.038). Minor complication rates were similar (LSR 36.5% vs. OSR 38.5%; P = 0.839). LSR patients had less pain (Visual Analog Scale 1.6; P = 0.0003), systemic analgesia requirement (P = 0.029), and returned home earlier (P = 0.046). The short form-36 questionnaire showed significantly better quality of life for LSR. CONCLUSIONS: LSR was associated with a 15.4% reduction in major complication rates, less pain, improved quality of life, and shorter hospitalization at the cost of a longer operating time.

The Sigma-trial protocol: a prospective double-blind multi-centre comparison of laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis.

BACKGROUND: Diverticulosis is a common disease in the western society with an incidence of 33-66%. 10-25% of these patients will develop diverticulitis. In order to prevent a high-risk acute operation it is advised to perform elective sigmoid resection after two episodes of diverticulitis in the elderly patient or after one episode in the younger (< 50 years) patient. Open sigmoid resection is still the gold standard, but laparoscopic colon resections seem to have certain advantages over open procedures. On the other hand, a double blind investigation has never been performed. The Sigma-trial is designed to evaluate the presumed advantages of laparoscopic over open sigmoid resections in patients with symptomatic diverticulitis. METHOD: Indication for elective resection is one episode of diverticulitis in patients < 50 years and two episodes in patient > 50 years or in case of progressive abdominal complaints due to strictures caused by a previous episode of diverticulits. The diagnosis is confirmed by CT-scan, barium enema and/or coloscopy. It is required that the participating surgeons have performed at least 15 laparoscopic and open sigmoid resections. Open resection is performed by median laparotomy, laparoscopic resection is approached by 4 or 5 cannula. Sigmoid and colon which contain serosal changes or induration are removed and a tension free anastomosis is created. After completion of either surgical procedure an opaque dressing will be used, covering from 10 cm above the umbilicus to the pubic bone. Surgery details will be kept separate from the patient's notes. Primary endpoints are the postoperative morbidity and mortality. We divided morbidity in minor (e.g. wound infection), major (e.g. anastomotic leakage) and late (e.g. incisional hernias) complications, data will be collected during hospital stay and after six weeks and six months postoperative. Secondary endpoints are the operative and the postoperative recovery data. Operative data include duration of the operation, blood loss and conversion to laparotomy. Post operative recovery consists of return to normal diet, pain, analgesics, general health (SF-36 questionnaire) and duration of hospital stay. DISCUSSION: The Sigma-trial is a prospective, multi-center, double-blind, randomized study to define the role of laparoscopic sigmoid resection in patients with symptomatic diverticulitis.

Minimally invasive esophageal resection.

Esophagus resection is the adequate treatment for some benign esophageal diseases, especially caustic and peptic stenosis and end-stage motility dysfunction. However, the most frequent indications for esophageal resection are the high-grade dysplasia of Barrett esophagus and nonmetastasized esophageal cancer. Different procedures have been developed to perform esophageal resection given the 5-year survival rate among operated patients of only 18%. The disadvantage of the conventional approach is the high morbidity rate, especially with pulmonary complications. Minimally invasive esophageal resections, which were first performed in 1991, may reduce this important morbidity and preserve the oncologic outcome. The first reports of morbidity and respiratory complications with this approach were discouraging and it seemed likely that the procedure would have to be abandoned. However, in the last 5 years, an important impetus for these techniques was given by Japanese groups and the group of Luketich in Pittsburgh. The outcomes of these new series are different than those of the beginning period, leading to an enormous expansion worldwide. Important factors for this change are the standardization of the operative technique, the experience of many surgeons with more advanced laparoscopic procedures, important improvements in instruments for dissection and division of tissues, a better anesthesia technique, and a better selection of patients for operation. Two minimally invasive techniques are being perfected: the three-stage operation by right thoracoscopy and laparoscopy, and the transhiatal laparoscopic approach. It seems that the first approach may be applied successfully for any tumor in the esophagus, whereas the transhiatal seems ideal for distal esophageal and esophagogastric junction tumors. This review paper discusses all these aspects, with special attention for indications and operative technique.

Scoring and diagnostic laparoscopy for suspected appendicitis.

OBJECTIVE: To develop a reproducible scoring system to identify patients who present with a doubtful diagnosis of appendicitis and who would benefit from diagnostic laparoscopy. DESIGN: Prospective observational study. SETTING: Regional teaching hospital, The Netherlands. SUBJECTS: 577 consecutive patients during the period 1994-5, and 343 who presented during the period 1996-7. INTERVENTIONS: The variables that seemed to be predictive of acute appendicitis were abstracted from the earlier group. a logistic regression analysis applied, and score created. The score was validated on the 343 patients who presented during 1996-7, and then the groups were combined for further analysis. MAIN OUTCOME MEASURES: Reproducibility of the scoring system obtained by comparing odds ratios (OR) of the two groups; its effectiveness judged by comparing the delayed and normal appendicectomy rates. RESULTS: The following variables were significantly correlated with the presence of acute appendicitis: white cell count 10 x 10(9)/L or more (score 3), rebound tenderness and male sex (score 2 each); and symptoms present for < 48 hrs and temperature 38 degrees C or more (score 1 each). The OR for the two groups were 1.80 and 1.76, respectively, indicating that score was reproducible. With a sensitivity of 93% and a specificity of 83% it would be at least as accurate as clinical judgment. The normal appendicectomy rate would be 7% instead of 9%. and the negative exploration rates (laparoscopy and primary appendicectomy) would both be 22%. The score would also result in a lower perforation rate (2% compared with 17%). CONCLUSION: The score can indicate when there is an indication for laparoscopy in patients with suspected appendicitis.