NCT02012023

Brief Summary

Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality associated with anastomotic leakage (AL) in patients with high risk factors on AL who are undergoing low anterior resections(LAR). This exploratory study was conducted to evaluate the efficacy and safety of one kind of controllable tube ileostomy(CTI), which was designed to protect rectal anastomosis in patients with high risk factors on AL. Results of SCCI were compared to those of the loop ileostomy (LI) method. In fact when we told the patients about the tube ileustomy's effect and risk, almost all the almost all of my patients like to choose tube ileustomy(I have study this method for long time and have good expeience, and my patients either choose tube ileostomy directly or let me do the choice.) So I gave all the patients who meet the requirenments all tube ileustomy and have no control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 23, 2016

Status Verified

July 1, 2016

Enrollment Period

2.6 years

First QC Date

December 4, 2013

Last Update Submit

August 21, 2016

Conditions

Rectal NeoplasmsLow Anterior Resection

Keywords

Low anterior resectionAnastomotic leakageDefunctioning stomaControllable tube ileostomyLoop ileostomy

Outcome Measures

Primary Outcomes (3)

  • anastomotic leakage

    Anastomotic leakage(AL) is the main complication after LAR.AL is defined as a defect of intestinal wall integrity at the colorectal or coloanal anastomotic site (including suture and staple lines of the neorectal reservoirs) leading to communication between intra- and extraluminal compartments.

    about in 3 months after operaion

  • reoperation rate

    When AL occurred, whether this patient need reoperation is determined by the clinical manifestation. Reoperation rate and mortality are two key index to evaluate the effect and safety of cannula ileostomy.

    about 3 months after operation

  • mortality

    about 3 months after operation

Secondary Outcomes (2)

  • ileus rate

    during the follow time(about 6 months after operaion)

  • operation data

    durting the operation time (about 1-5 h)

Other Outcomes (2)

  • hospital stays

    from admission time to discharge time(about 7-14days)

  • hospital costs

    from admission time to discharge time(about 7-14days)

Study Arms (2)

Controllable tube ileostomy

EXPERIMENTAL

After LAR, the experimental group accepted controllable tube ileostomy.

Device: Low anterior resectionDevice: tube ileostomyDevice: remove the tube ileostomy

Loop ileostomy

ACTIVE COMPARATOR

After LAR, the experimental group accepted loop ileostomy.

Device: Low anterior resectionDevice: loop ileostomyDevice: accept reversal operation

Interventions

Low anterior resectionDEVICE
Controllable tube ileostomyLoop ileostomy
tube ileostomyDEVICE
Controllable tube ileostomy
loop ileostomyDEVICE
Loop ileostomy
accept reversal operationDEVICE
Loop ileostomy
remove the tube ileostomyDEVICE
Controllable tube ileostomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Rectal Tumor After Low Anterior Resection the Anastomosis Located extraperitoneal
  • Patients Agreed to Undergo the tube ileostomy or loop ileostomy Procedure

You may not qualify if:

  • Bowel Preparation is not Satisfied Before Operation
  • Blood lose is more than 1500ml during operation
  • Critical incident during operation
  • The vagina or bladder is seriously damaged and the fix is not satisfied.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Colorectal Surgery, First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Rectal NeoplasmsAnastomotic Leak

Interventions

Ileostomy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EnterostomyDigestive System Surgical ProceduresSurgical Procedures, OperativeOstomy

Study Officials

  • Hua Hanju, Doctor

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 16, 2013

Study Start

January 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 23, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

Locations

CN(1)