Complex colorectal polyps
| ISRCTN | ISRCTN99658893 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99658893 |
| Secondary identifying numbers | Clinical audit number SUR/NP/15/038 |
- Submission date
- 12/07/2016
- Registration date
- 24/07/2016
- Last edited
- 10/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Watford Road
St Mark's Hospital and Academic Institute
Harrow
HA1 3UJ
United Kingdom
 ORCID ID |
0000-0003-0235-7110 |
|---|
Study information
| Study design | Observational case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Complex colorectal polyps; tailoring endoscopic techniques and monitoring endoscopic outcomes |
| Study acronym | CCP |
| Study objectives | 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(s) | Clinical audit as part of good clinical practice |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2010 |
| Completion date | 01/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | >300 |
| Total final enrolment | 330 |
| Key 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 |
| Key exclusion criteria | Bowel cancer screening patients |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 01/08/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Harrow
HA1 3UJ
United Kingdom
Sponsor information
Hospital/treatment centre
Watford Road
Clinical Governance Department
Harrow
HA1 3UJ
England
United Kingdom
"ROR" |
https://ror.org/04cntmc13 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/07/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Submission in progress |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2018 | Yes | No |
Editorial Notes
10/05/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
