NCT02665026

Brief Summary

The purpose of this study is to evaluate the appropriate timing to do preventive ileostomy closure after total mesorectal excision of rectal cancer. To evaluate the effectiveness and safety of preventive ileostomy closure at different time (12 weeks / 24 weeks after radical resection of rectal carcinoma). This study was expected to demonstrate that the early preventive ileostomy closure after total mesorectal excision of rectal cancer does not increase the risk of complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 4, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

5.2 years

First QC Date

January 23, 2016

Last Update Submit

September 19, 2021

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Postoperative complication

    within the first 2 weeks after surgery

Secondary Outcomes (3)

  • Postoperative quality of life

    five years

  • survival rate

    five years

  • Disease-free survival

    five years

Study Arms (1)

stoma closure at different times

EXPERIMENTAL

choose different times to do stoma closure after surgery for rectal cancer

Procedure: stoma closure at different times

Interventions

stoma closure at different timesPROCEDURE

Early closure: stoma closure in 12 weeks after surgery for rectal cancer; Late group: stoma closure in 24 weeks after surgery for rectal cancer

stoma closure at different times

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sign the informed consent
  • postoperative pathology is rectal adenocarcinoma
  • primary middle and low rectal cancer patients (tumor distance from the anal margin is less than 10 cm)
  • underwent total mesorectal excision for rectal cancer with preventive loop ileostomy

You may not qualify if:

  • postoperative pathology is not rectal adenocarcinoma (rectal neuroendocrine tumor, lymphoma, etc.)
  • postoperative pathologic staging of rectal cancer is I phase, II phase
  • underwent total mesorectal excision for rectal cancer without preventive loop ileostomy
  • emergency operation for rectal cancer
  • disease progression (local recurrence or distant metastasis, etc.)
  • anastomotic stenosis
  • serious system disease, including heart dysfunction, respiratory insufficiency, liver and kidney dysfunction, serious blood diseases
  • participate in other clinical trial
  • pregnancy or perinatal woman
  • combined with other malignant tumor
  • with a history of neurological and psychiatric disorders
  • patients with abnormal bone marrow suppression after chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, 200040, China

Location

Related Publications (3)

  • Matthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. doi: 10.1097/SLA.0b013e3180603024.

    PMID: 17667498BACKGROUND

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PMID: 15273542BACKGROUND

  • Tulchinsky H, Shacham-Shmueli E, Klausner JM, Inbar M, Geva R. Should a loop ileostomy closure in rectal cancer patients be done during or after adjuvant chemotherapy? J Surg Oncol. 2014 Mar;109(3):266-9. doi: 10.1002/jso.23493. Epub 2013 Nov 19.

    PMID: 24249401BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jianbin Xiang, doctor

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 23, 2016

First Posted

January 27, 2016

Study Start

January 4, 2016

Primary Completion

March 22, 2021

Study Completion

March 31, 2021

Last Updated

September 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion.

Locations

CN(1)