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Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer

Primary Purpose

Rectal Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cannula ileostomy
loop ileostomy
LAR
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms focused on measuring LAR, anastomotic leakage, Cannula ileostomy, loop ileostomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Rectal Tumor After Low Anterior Resection the Anastomosis Located extraperitoneal.
  2. Intraperitoneal Anastomosis Who Used of Glucocorticoid or Accepted Neoadjuvant Chemoradiotherapy.
  3. Patients Agreed to Undergo the Canula Ileostomy or Loop Ileostomy Procedure

Exclusion Criteria:

  1. 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)
  2. positive air leakage test
  3. fractured anastomotic rings

Sites / Locations

  • Department of Colorectal Surgery, First Affiliated Hospital, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cannula ileostomy

loop ileostomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

ileus rate
Another main operation complication was intestinal obstruction. Ileus conclude two types: temporally ileus and intractable ileus. Temporally ileus can be treated by conservative treatment and intractable ileus need reoperation.Ileus usually is caused by intestinal adhesion. But in cannula ileostomy group, ileus maybe caused by the cannula obstruction.

Full Information

First Posted
October 23, 2013
Last Updated
November 16, 2013
Sponsor
First Affiliated Hospital of Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT01980238
Brief Title
Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer
Official Title
Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Zhejiang University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
After low anterior resection(LAR), in the LI group, the operation method was done as surgeons all known. In the cannula ileostomy group, a double row of concentric purse-string sutures were placed in the ileum wall using 3-0 absorbable suture. The diameters of the purse-string rings were about 10 mm and 20 mm, respectively. The investigators then made a small incision within the inner purse-string and inserted the trachea cannula into the proximal end of the ileum. The inner purse-string suture then was tied, followed by the outer purse-string suture. The outer purse string should capsulate the inner purse string to prevent leakage. Normal saline was injected into the air bag until the ileum wall began to turn pale. The investigators then pulled the cannula out through the abdominal wall. The incision site in the ileum was approximated to the inner abdominal wall and extraperitonized by fixing the mobilized ileum wall around the cannula to the inner abdominal wall. This was accomplished using 3-4 interrupted sutures. In the LI group, patients accepted reversal operation at least 3 months after operation if operation condition permission. In the cannula ileostomy group, the cannula will be removed after 3-4 weeks. If anastomotic leakage occurred, The investigators will keep the cannula until the anastomotic leakage was cured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
LAR, anastomotic leakage, Cannula ileostomy, loop ileostomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cannula ileostomy
Arm Type
Experimental
Arm Description
After LAR, experimental group will accept cannula ileostomy. Operation has described in the Detailed Description.
Arm Title
loop ileostomy
Arm Type
Active Comparator
Arm Description
After LAR, active comparator group will accept loop ileostomy. This operation is well known by colorectal surgeons.
Intervention Type
Device
Intervention Name(s)
cannula ileostomy
Intervention Type
Device
Intervention Name(s)
loop ileostomy
Intervention Type
Device
Intervention Name(s)
LAR
Other Intervention Name(s)
Low anterior resection
Primary Outcome Measure Information:
Title
anastomotic leakage, reoperation and mortality rate
Description
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.
Time Frame
about in 3 months after operaion.
Secondary Outcome Measure Information:
Title
ileus rate
Description
Another main operation complication was intestinal obstruction. Ileus conclude two types: temporally ileus and intractable ileus. Temporally ileus can be treated by conservative treatment and intractable ileus need reoperation.Ileus usually is caused by intestinal adhesion. But in cannula ileostomy group, ileus maybe caused by the cannula obstruction.
Time Frame
during the follow time(about 6 months after operaion)
Other Pre-specified Outcome Measures:
Title
hospital stays and costs
Description
In loop ileostomy group, hospital stays and costs include the readmission to close the stoma.
Time Frame
from admission time to discharge time(about 7-14days)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Department of Colorectal Surgery, First Affiliated Hospital, Zhejiang University
City
Hangzhou,
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China

12. IPD Sharing Statement

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Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer

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