- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01980238
Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer
Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zhejiang
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Hangzhou,, Zhejiang, China, 310003
- Department of Colorectal Surgery, First Affiliated Hospital, Zhejiang University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cannula ileostomy
After LAR, experimental group will accept cannula ileostomy.
Operation has described in the Detailed Description.
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Other Names:
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Active Comparator: loop ileostomy
After LAR, active comparator group will accept loop ileostomy.
This operation is well known by colorectal surgeons.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
anastomotic leakage, reoperation and mortality rate
Time Frame: about in 3 months after operaion.
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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.
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about in 3 months after operaion.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ileus rate
Time Frame: during the follow time(about 6 months after operaion)
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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.
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during the follow time(about 6 months after operaion)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hospital stays and costs
Time Frame: from admission time to discharge time(about 7-14days)
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In loop ileostomy group, hospital stays and costs include the readmission to close the stoma.
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from admission time to discharge time(about 7-14days)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- cannula ileostomy
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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