Plain English Summary
Background and study aims
Large polyps (growth of tissue with a stalk) in the colon or rectum which develop into bowel cancer if left untreated are increasingly identified at colonoscopy (a test where a small tube fitted with a camera and a light is fed though the length of the the colon to take a look) and because of bowel cancer screening. These large polyps can be removed at colonoscopy by snare resection and other techniques. Making sure that the polyp isn’t cancerous already and choosing the best technique to remove it (best resection technique) are important and complications may occur. This study is reporting on the tailored endoscopic techniques required to treat these polyps and the outcomes after their removal, including rates of cancer (how many patients go on to develop cancer), need for salvage surgery (for example, to repair severe damage), polyp recurrence rates (number of polyps that come back) and complication rates.
Who can participate?
Adults aged 18 or over who have a large colorectal polyp to be removed with the aid of colonoscopy at St Mark’s Hospital London.
What does the study involve?
Patients are admitted to hospital and undergo treatment to remove their their polyp at St Marks after discussion of their treatment options and providing informed consent as part of standard clinical practice. Anonymised patient data (data that has all identifying information for each patient removed) is kept in a secure database and analysed at the end of the study period with a view to publication and dissemination (sharing) of these data in the medical literature.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. A registry will be created based on the findings of the study aiming to be beneficial to future patients who undergo polyp removal surgery. There are no significant risks of participating in this study.
Where is the study run from?
Wolfson Endoscopy Unit at St Mark’s Hospital (London)
When is the study starting and how long is it expected to run for?
January 2010 to August 2015
Who is funding the study?
St Mark's Hospital and Academic Institute (London)
Who is the main contact?
Dr Zacharias Tsiamoulos
Trial website
Contact information
Type
Scientific
Primary contact
Dr Zacharias Tsiamoulos
ORCID ID
http://orcid.org/0000-0003-0235-7110
Contact details
Watford Road
St Mark's Hospital and Academic Institute
Harrow
HA1 3UJ
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Clinical audit number SUR/NP/15/038
Study information
Scientific title
Complex colorectal polyps; tailoring endoscopic techniques and monitoring endoscopic outcomes
Acronym
CCP
Study hypothesis
Patients with large non-pedunculated colorectal polyps (NPCPs) are increasingly referred for piecemeal endoscopic mucosal resection (p-EMR). This prospective audit reports on the management of all patients with large NPCPs referred to a tertiary centre over a two and half year period. We also aimed to describe features that contribute to complexity of large NPCPs, suitability for endoscopic resection in a tertiary centre and the endoscopic resection techniques required.
Ethics approval
Clinical audit as part of good clinical practice
Study design
Observational case series
Primary study design
Observational
Secondary study design
Case series
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Piecemeal Resection Polypectomy techniques within St Mark's Hospital/Academic Institute, London North West Healthcare
Intervention
A prospective audit of consecutive patients with NPCPs ≥ 20mm referred for consideration of endoscopic resection to our tertiary centre between January 2010 and August 2012 was performed including the long term follow up until August 2015. Clinical and demographic information were recorded. NPCPs were evaluated in a standardised fashion at colonoscopy. After endoscopic evaluation, a resection strategy plan was formulated for each polyp where p-EMR was deemed suitable. Four variations of endoscopic resection technique were employed. Intraprocedural and immediate post-procedural adverse events (bleeding, perforation, vasovagal episodes and post-polypectomy syndrome) were recorded. Patients were followed up at 14 days post procedure with a telephone call to record any other complications. Post-operative admissions for complications were recorded. Patients underwent surveillance colonoscopies at between 3-9 months (early follow up) and then at 15 +/- 24 months (late follow up) for evaluation of polyp recurrence.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
1. Total number of patients (referring letters / nature of referrals - local or tertiary) referred to Wolfson Unit for Endoscopy/Academic Institute
2. Piecemeal resection Outcomes (short term/15 day telephone, 3-6-9 months follow up-recurrence and long term/15-24-36 months follow up-recurrence)
3. Piecemeal resection complication rates (short and long term)
4. Patients referred to surgery (due to benign or malignant recurrence)
Secondary outcome measures
1. Management resection plan for all referrals (excised polyps and non-excised polyps/abandonded or not attempted cases)
2. Safety and Efficacy of the Piecemeal Resection techniques utilised
3. Safety of the patients (mortality and morbidity rates)
Overall trial start date
01/01/2010
Overall trial end date
01/08/2015
Reason abandoned
Eligibility
Participant inclusion criteria
All consecutive referrals (local/tertiary referrals) to Wolfson unit for Endoscopy at St Mark’s Hospital/Academic Institute at London North West Healthcare
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
>300
Participant exclusion criteria
Bowel cancer screening patients
Recruitment start date
01/01/2010
Recruitment end date
01/08/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wolfson Unit for Endoscopy, St Mark's Hospital/Academic institute
Watford Road
Harrow
HA1 3UJ
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
St Mark's Hospital and Academic Institute
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Submission in progress
Intention to publish date
30/07/2016
Participant level data
Available on request
Results - basic reporting
Publication summary