Condition category
Cancer
Date applied
12/07/2016
Date assigned
24/07/2016
Last edited
22/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

London North West Healthcare NHS Trust

Sponsor details

Watford Road
Clinical Governance Department
Harrow
HA1 3UJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes