NCT01980238

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 anterior resections. Although debate about the use of defunctioning stoma continues, meta-analyses and randomized multicenter trial results support the use of defunctioning stoma in lower anterior resection(LAR). This exploratory study was conducted to evaluate the efficacy and safety of a new diversion method called spontaneously closed cannula ileostomy (SCCI), 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.

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

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

Study Start

First participant enrolled

January 1, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

2.9 years

First QC Date

October 23, 2013

Last Update Submit

November 16, 2013

Conditions

Rectal Neoplasms

Keywords

LARanastomotic leakageCannula ileostomyloop ileostomy

Outcome Measures

Primary Outcomes (1)

  • anastomotic leakage, reoperation and mortality rate

    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. 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 in 3 months after operaion.

Secondary Outcomes (1)

  • ileus rate

    during the follow time(about 6 months after operaion)

Other Outcomes (1)

  • hospital stays and costs

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

Study Arms (2)

cannula ileostomy

EXPERIMENTAL

After LAR, experimental group will accept cannula ileostomy. Operation has described in the Detailed Description.

Device: cannula ileostomyDevice: LAR

loop ileostomy

ACTIVE COMPARATOR

After LAR, active comparator group will accept loop ileostomy. This operation is well known by colorectal surgeons.

Device: loop ileostomyDevice: LAR

Interventions

cannula ileostomyDEVICE
cannula ileostomy
loop ileostomyDEVICE
loop ileostomy
LARDEVICE
Also known as: Low anterior resection
cannula ileostomyloop 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.
  • Intraperitoneal Anastomosis Who Used of Glucocorticoid or Accepted Neoadjuvant Chemoradiotherapy.
  • Patients Agreed to Undergo the Canula Ileostomy or Loop Ileostomy Procedure

You may not qualify if:

  • Bowel Preparation is Satisfied Before Operation(This Means That if Surgeons Find That There is Much Feces Left in the Colon,the Patient Will be Excluded)
  • positive air leakage test
  • fractured anastomotic rings

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 Design

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

Study Record Dates

First Submitted

October 23, 2013

First Posted

November 8, 2013

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

CN(1)