Back to resultsTransanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor
Primary Purpose
Colorectal Tumor
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transanal Tube Drainage
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Tumor focused on measuring ESD;Transanal Tube Drainage;Colorectal Tumor
Eligibility Criteria
Inclusion Criteria:
- Endoscopy proven colorectal polyp>2cm, LST>3cm, SMTs<2cm Suitable for ESD No other organic disease of colorectal Removing a single lesion one time Informed consent
Exclusion Criteria:
- Complicated other colorectal diseases, such as,Crohn's disease Familial adenomatous polyposis With previous colorectal surgery Pregnancy or lactation Absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class > III) ESD conversion to laparotomy Patients cannot receive ESD Patients and/or family members can not understand and accept this study
Sites / Locations
- Endoscopy Center, Zhongshan Hospital, Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Transanal Tube Drainage
Without Transanal Tube Drainage
Arm Description
patients with transanal tube drainage after ESD
patients without transanal tube drainage after ESD
Outcomes
Primary Outcome Measures
postoperative complications
bleeding, perforation,coagulation syndrome
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02973490
Brief Title
Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor
Official Title
Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group, Superiority Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We design the clincal trial to investigate the efficacy of transanal tube drainage in colorectal ESD.
Detailed Description
Endoscopic submucosal dissection (ESD) is a technique for endoscopic tissue resection that enables endoscopists to control the depth and direction of diathermic knife incisions.Recently, the number of reports in which ESD has been successfully used to treat colorectal tumors has increased. But the complatios with colorectal ESD were higher than esophagus and stomach ESD.We design the clincal trial to investigate the efficacy of transanal tube drainage in colorectal ESD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Tumor
Keywords
ESD;Transanal Tube Drainage;Colorectal Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transanal Tube Drainage
Arm Type
Experimental
Arm Description
patients with transanal tube drainage after ESD
Arm Title
Without Transanal Tube Drainage
Arm Type
No Intervention
Arm Description
patients without transanal tube drainage after ESD
Intervention Type
Device
Intervention Name(s)
Transanal Tube Drainage
Intervention Description
Using transanal tube drainage after colorectal ESD
Primary Outcome Measure Information:
Title
postoperative complications
Description
bleeding, perforation,coagulation syndrome
Time Frame
30 days post operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Endoscopy proven colorectal polyp>2cm, LST>3cm, SMTs<2cm Suitable for ESD No other organic disease of colorectal Removing a single lesion one time Informed consent
Exclusion Criteria:
Complicated other colorectal diseases, such as,Crohn's disease Familial adenomatous polyposis With previous colorectal surgery Pregnancy or lactation Absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class > III) ESD conversion to laparotomy Patients cannot receive ESD Patients and/or family members can not understand and accept this study
Facility Information:
Facility Name
Endoscopy Center, Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor
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