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Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor

NCT ID: NCT02973490

Last Updated: 2016-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Colorectal Tumor

Keywords

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ESD;Transanal Tube Drainage;Colorectal Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transanal Tube Drainage

patients with transanal tube drainage after ESD

Group Type EXPERIMENTAL

Transanal Tube Drainage

Intervention Type DEVICE

Using transanal tube drainage after colorectal ESD

Without Transanal Tube Drainage

patients without transanal tube drainage after ESD

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Transanal Tube Drainage

Using transanal tube drainage after colorectal ESD

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Xu jianmin

Zhongshan Hospital Endoscopy center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Endoscopy Center, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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D2016-11

Identifier Type: -

Identifier Source: org_study_id