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Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor

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ClinicalTrials.gov Identifier: NCT02973490
Recruitment Status : Not yet recruiting
First Posted : November 25, 2016
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
Xu jianmin, Fudan University

Brief Summary:
We design the clincal trial to investigate the efficacy of transanal tube drainage in colorectal ESD.

Condition or disease Intervention/treatment Phase
Colorectal Tumor Device: Transanal Tube Drainage Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transanal Tube Drainage
patients with transanal tube drainage after ESD
Device: Transanal Tube Drainage
Using transanal tube drainage after colorectal ESD

No Intervention: Without Transanal Tube Drainage
patients without transanal tube drainage after ESD



Primary Outcome Measures :
  1. postoperative complications [ Time Frame: 30 days post operatively ]
    bleeding, perforation,coagulation syndrome



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973490


Locations
China, Shanghai
Endoscopy Center, Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University

Responsible Party: Xu jianmin, Zhongshan Hospital Endoscopy center, Fudan University
ClinicalTrials.gov Identifier: NCT02973490     History of Changes
Other Study ID Numbers: D2016-11
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Xu jianmin, Fudan University:
ESD;Transanal Tube Drainage;Colorectal Tumor

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases