4 results on '"Klarenbeek BR"'
Search Results
2. Pelvic floor rehabilitation to improve functional outcome and quality of life after surgery for rectal cancer: study protocol for a randomized controlled trial (FORCE trial).
- Author
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Kalkdijk-Dijkstra AJ, van der Heijden JAG, van Westreenen HL, Broens PMA, Trzpis M, Pierie JPEN, and Klarenbeek BR
- Subjects
- Humans, Cost-Benefit Analysis, Health Care Costs, Netherlands, Quality of Life, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Fecal Incontinence economics, Fecal Incontinence physiopathology, Fecal Incontinence psychology, Fecal Incontinence rehabilitation, Pelvic Floor, Physical Therapy Modalities, Postoperative Complications economics, Postoperative Complications physiopathology, Postoperative Complications psychology, Postoperative Complications rehabilitation, Proctectomy, Rectal Neoplasms surgery
- Abstract
Background: After low anterior resection (LAR), up to 90% of patients develop anorectal dysfunction. Especially fecal incontinence has a major impact on the physical, psychological, social, and emotional functioning of the patient but also on the Dutch National Healthcare budget with more than €2000 spent per patient per year. No standardized treatment is available to help these patients. Common treatment nowadays is focused on symptom relief, consisting of lifestyle advices and pharmacotherapy with bulking agents or antidiarrheal medication. Another possibility is pelvic floor rehabilitation (PFR), which is one of the most important treatments for fecal incontinence in general, with success rates of 50-80%. No strong evidence is available for the use of PFR after LAR. This study aims to prove a beneficial effect of PFR on fecal incontinence, quality of life, and costs in rectal cancer patients after sphincter-saving surgery compared to standard treatment., Methods: The FORCE trial is a multicenter, two-armed, randomized clinical trial. All patients that underwent LAR are recruited from the participating hospitals and randomized for either standard treatment or a standardized PFR program. A total of 128 patients should be randomized. Optimal blinding is not possible. Stratification will be done in variable blocks (gender and additional radiotherapy). The primary endpoint is the Wexner incontinence score; secondary endpoints are health-related and fecal-incontinence-related QoL and cost-effectiveness. Baseline measurements take place before randomization. The primary endpoint is measured 3 months after the start of the intervention, with a 1-year follow-up for sustainability research purposes., Discussion: The results of this study may substantially improve postoperative care for patients with fecal incontinence or anorectal dysfunction after LAR. This section provides insight in the decisions that were made in the organization of this trial., Trial Registration: Netherlands Trial Registration, NTR5469, registered on 03-09-2015. Protocol FORCE trial V18, 19-09-2019. Sponsor Radboud University Medical Center, Nijmegen.
- Published
- 2020
- Full Text
- View/download PDF
3. Intrathoracic versus Cervical ANastomosis after minimally invasive esophagectomy for esophageal cancer: study protocol of the ICAN randomized controlled trial.
- Author
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van Workum F, Bouwense SA, Luyer MD, Nieuwenhuijzen GA, van der Peet DL, Daams F, Kouwenhoven EA, van Det MJ, van den Wildenberg FJ, Polat F, Gisbertz SS, Henegouwen MI, Heisterkamp J, Langenhoff BS, Martijnse IS, Grutters JP, Klarenbeek BR, Rovers MM, and Rosman C
- Subjects
- Anastomosis, Surgical adverse effects, Cost-Benefit Analysis, Data Collection, Esophagectomy adverse effects, Humans, Quality of Life, Anastomosis, Surgical methods, Clinical Protocols, Esophageal Neoplasms surgery, Esophagectomy methods, Minimally Invasive Surgical Procedures methods
- Abstract
Background: Currently, a cervical esophagogastric anastomosis (CEA) is often performed after minimally invasive esophagectomy (MIE). However, the CEA is associated with a considerable incidence of anastomotic leakage requiring reintervention or reoperation and moderate functional results. An intrathoracic esophagogastric anastomosis (IEA) might reduce the incidence of anastomotic leakage, improve functional results and reduce costs. The objective of the ICAN trial is to compare anastomotic leakage and postoperative morbidity, mortality, quality of life and cost-effectiveness between CEA and IEA after MIE., Methods/design: The ICAN trial is an open randomized controlled multicentre superiority trial, comparing CEA (control group) with IEA (intervention group) after MIE. All patients with esophageal cancer planning to undergo curative MIE are considered for inclusion. A total of 200 patients will be included in the study and randomized between the groups in a 1:1 ratio. The primary outcome is anastomotic leakage requiring reintervention or reoperation, and secondary outcomes are (amongst others) other postoperative complications, new onset of organ failure, length of stay, mortality, benign strictures requiring dilatation, quality of life and cost-effectiveness., Discussion: We hypothesize that an IEA after MIE is associated with a lower incidence of anastomotic leakage requiring reintervention or reoperation than a CEA. The trial is also designed to give answers to additional research questions regarding a possible difference in functional outcome, quality of life and cost-effectiveness., Trial Registration: Netherlands Trial Register: NTR4333 . Registered on 23 December 2013.
- Published
- 2016
- Full Text
- View/download PDF
4. The Sigma-trial protocol: a prospective double-blind multi-centre comparison of laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis.
- Author
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Klarenbeek BR, Veenhof AA, de Lange ES, Bemelman WA, Bergamaschi R, Heres P, Lacy AM, van den Broek WT, van der Peet DL, and Cuesta MA
- Subjects
- Double-Blind Method, Follow-Up Studies, Humans, Middle Aged, Pain diagnosis, Pain prevention & control, Pain Measurement, Prospective Studies, Treatment Outcome, Colectomy methods, Colon, Sigmoid surgery, Diverticulitis, Colonic surgery, Elective Surgical Procedures methods, Laparoscopy, Laparotomy
- Abstract
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.
- Published
- 2007
- Full Text
- View/download PDF
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