Randomised Comparison of 2 Cold Snare Polypectomy Techniques
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Вход / Регистрация
Линкът е запазен в клипборда
СъстояниеЗавършен
Спонсори
Sheffield Teaching Hospitals NHS Foundation Trust
КЛИНИЧНО ИЗСЛЕДВАНЕ: NCT02208401
BioSeek: NCT02208401
Ключови думи
Резюме
Different modalities are employed to remove small colonic polyps which potentially harbour a cancer risk. But, they can all vary in their completeness of removal, safety and the histological quality and the gold standard technique has yet to be defined. A novel suction pseudopolyp technique has been described by Patullo et al and in their prospective study, 126 polyps measuring less than 10mm flat or sessile were removed by this method with 100% complete endoscopic resection and without any immediate or delayed complications. The aim of the investigators study is to compare this technique with the standard cold snare technique. Patients attending for a routine colonoscopy and found to have polyps measuring 37mm in size will be eligible and they will be randomised to the polypectomy technique. Patient demographics and polyp characteristics will be recorded. The primary outcome measured will be the macroscopic resection rate. The secondary outcome measures are abdominal pain, tenderness, bleeding and fever.
Дати
Последна проверка: | 07/31/2014 |
Първо изпратено: | 07/29/2014 |
Очаквано записване подадено: | 08/03/2014 |
Първо публикувано: | 08/04/2014 |
Изпратена последна актуализация: | 08/11/2014 |
Последна актуализация публикувана: | 08/12/2014 |
Действителна начална дата на проучването: | 12/31/2013 |
Приблизителна дата на първично завършване: | 07/31/2014 |
Очаквана дата на завършване на проучването: | 07/31/2014 |
Състояние или заболяване
Bowel Cancer
Интервенция / лечение
Procedure: conventional cold snare polypectomy
Procedure: Cold snare polypectomy with suction
Фаза
-
Групи за ръце
Arm | Интервенция / лечение |
---|---|
Active Comparator: conventional cold snare polypectomy conventional cold snare polypectomy | Procedure: conventional cold snare polypectomy conventional cold snare polypectomy |
Experimental: Cold snare polypectomy with suction Cold snare polypectomy with suction | Procedure: Cold snare polypectomy with suction Cold snare polypectomy with suction |
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
Полове, допустими за проучване | All |
Приема здрави доброволци | Да |
Критерии | Inclusion Criteria: - All patients with small polyps 3-7 mm in size, flat or sessile found during colonoscopy Exclusion Criteria: - Patients are less than 18 years old - Pregnant - Inadequate bowel preparation - On anticoagulants or clopidogrel |
Резултат
Първични изходни мерки
1. Complete macroscopic polyp eradication rate [At time of polypectomy intervention]
The primary outcome for this study is the polypectomy completion rate. This will be assessed both macroscopically and histologically. The analysis for statistical difference between the 2 techniques and abdominal symptoms will be compared by the Chi2 test for categorical data.