NCT02973490

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

November 25, 2016

Status Verified

October 1, 2016

Enrollment Period

4.9 years

First QC Date

November 22, 2016

Last Update Submit

November 22, 2016

Conditions

Colorectal Tumor

Keywords

ESD;Transanal Tube Drainage;Colorectal Tumor

Outcome Measures

Primary Outcomes (1)

  • postoperative complications

    bleeding, perforation,coagulation syndrome

    30 days post operatively

Study Arms (2)

Transanal Tube Drainage

EXPERIMENTAL

patients with transanal tube drainage after ESD

Device: Transanal Tube Drainage

Without Transanal Tube Drainage

NO INTERVENTION

patients without transanal tube drainage after ESD

Interventions

Transanal Tube DrainageDEVICE

Using transanal tube drainage after colorectal ESD

Transanal Tube Drainage

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Center, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zhongshan Hospital Endoscopy center

Study Record Dates

First Submitted

November 22, 2016

First Posted

November 25, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

November 25, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)