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van CCT (UK)

van CCT (UK)

The volume of colorectal surgery for benign polyps in the past decade

- candidate number26956
- NTR NumberNTR6294
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-mrt-2017
- Secondary IDsW15_289#15.0339 METC AMC
- Public TitleThe volume of colorectal surgery for benign polyps in the past decade
- Scientific TitleThe volume of colorectal surgery for benign polyps in the past decade
- hypothesisThis study aims to describe the volume of patients referred for colorectal surgery for removal of benign colorectal polyps and its morbidity and mortality in the North-West of the Netherlands between 2005 and 2015.
- Healt Condition(s) or Problem(s) studiedColorectal surgery, Polyps
- Inclusion criteriaWe will retrospectively include all patients who were treated with surgical resection of their benign large colorectal lesion in the regional hospitals and academic centers in the province of North-Holland. In order to be eligible to be included in this study a patient must meet all of the following criteria: - The patient underwent colorectal surgery between 2005 and 2015 in one of the participating hospitals for at least onea: - Colorectal polyp with benign histopathology, defined as a tubular, tubulovillous or villous adenoma or sessile serrated adenoma/polyp with low grade or high grade dysplasia, sessile serrated lesions or traditional serrated lesions with or without (high or low grade) dysplasia and hyperplastic polyps.
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from inclusion in this study:
- Clear signs of submucosal invasion at histopathology of the resection preparation
- Known with Inflammatory Bowel Disease
- Known with polyposis syndromes, like Familial Adenomatous Polyposis, Lynch Syndrome and Serrated Polyposis Syndrome
- Surgery for synchronous colorectal malignancy
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2016
- planned closingdate1-jul-2017
- Target number of participants0
- InterventionsThere are no formal interventions, since this is a retrospective multicenter cohort study in order to investigate the volume of performed colorectal surgery for benign colorectal polyps in the past decade.
- Primary outcomeOur main study endpoint is the overall volume of colorectal surgery as the treatment for benign colorectal polyps and volume changes in the past decade.
- Secondary outcomeThe following secondary study parameters are designed to further study the polyp, surgical and pre surgical endoscopy characteristics.
- Indications for surgical resection
- Reason for referral for surgical resections
- Types of surgery performed
- Complication and mortality rate associated with benign colorectal surgery
- Polyp location
- Mean polyp size
- Polyp morphology
- Endoscopic diagnosis during endoscopy
- Histopathologic diagnosis after surgery in the resection preparation
- Diagnosis made by gastroenterologist, surgeon or internist for referral for surgery.
- Indication for the colonoscopy that identified the large colorectal lesion
- Number of colonoscopies performed before referral for surgical resection
- Number of endoscopic polypectomy procedures
- Number of endoscopic polypectomy attempts after referral to a tertiary center
- Complication rate and mortality associated with colonoscopy
- Timepoints01-01-2016: submission of a conference abstract to the Digestive Disease Week 2017 and the Digestive Disease Days 2017
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESPhD Candidate Maxime E.S. Bronzwaer
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryTraditionally large and complex non-pedunculated colorectal polyps have been managed with surgical resection (SR). However over the past decade endoscopic resection (ER) techniques, such as piecemeal endoscopic mucosal resection (pEMR) and endoscopic submucosal dissection (ESD) of these polyps, have progressed significantly and are now applied in many endoscopy centers around the world. Replacing surgery by ER of these complex colorectal polyps will reduce surgerical morbidity, mortality and costs. It remains unclear to what extent ER has replaced SR. We therefore aim to perform a multicenter retrospective cohort study in the province of Noord-Holland in the Netherlands to assess the total volume of colorectal surgery for benign colorectal polyps and the absolute and relative volume changes over the past decade. Secondly, we will assess endoscopic characteristics of the resected lesions, surgery characteristics as well surgical related morbidity and mortality. This study was proposed to all 15 regional and 2 academic hospitals in the province of Noord-Holland (1.7 million inhabitants) in the Netherlands. We aim to include all patients who underwent surgical bowel resection for benign colorectal polyps between 2005 and 2015. Patients will be retrieved from the prospective nationwide Dutch Pathology Registry (PALGA-database), which was searched for all histopathological reports of surgical resection specimens containing benign colorectal polyps. Data concerning polyp, endoscopic and surgical characteristics will be collected from the patient records.
- Main changes (audit trail)
- RECORD26-mrt-2017 - 17-mei-2017

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