Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor

Sponsor

Fudan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02973490

Collaborator

(none)

1,200

Enrollment

Location

Arms

Duration (Months)

20.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

postoperative complications [30 days post operatively]
bleeding, perforation,coagulation syndrome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 >

ESD conversion to laparotomy Patients cannot receive ESD Patients and/or family members can not understand and accept this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Endoscopy Center, Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xu jianmin, Zhongshan Hospital Endoscopy center, Fudan University

ClinicalTrials.gov Identifier:

NCT02973490

Other Study ID Numbers:

D2016-11

First Posted:

Nov 25, 2016

Last Update Posted:

Nov 25, 2016

Last Verified:

Oct 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Xu jianmin, Zhongshan Hospital Endoscopy center, Fudan University

ESD;Transanal Tube Drainage;Colorectal Tumor

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Nov 25, 2016