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Use of One Kind of Controllable Tube Ileostomy in the Low Rectal Cancer (CTI)

Primary Purpose

Rectal Neoplasms, Low Anterior Resection

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low anterior resection
tube ileostomy
loop ileostomy
accept reversal operation
remove the tube ileostomy
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 Low anterior resection, Anastomotic leakage, Defunctioning stoma, Controllable tube ileostomy, Loop ileostomy

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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

Controllable tube ileostomy

Loop ileostomy

Arm Description

After LAR, the experimental group accepted controllable tube ileostomy.

After LAR, the experimental group accepted loop ileostomy.

Outcomes

Primary Outcome Measures

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.
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.
mortality

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 CTI group, ileus maybe caused by the cannula obstruction.
operation data
including operation method, time, blood loss et al.

Full Information

First Posted
December 4, 2013
Last Updated
August 21, 2016
Sponsor
First Affiliated Hospital of Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT02012023
Brief Title
Use of One Kind of Controllable Tube Ileostomy in the Low Rectal Cancer
Acronym
CTI
Official Title
Use of One Kind of Controllable Tube Ileostomy to Protect Anastomotic Leakage in the Low Rectal Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

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
Yes

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 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.
Detailed Description
After low anterior resection(LAR), 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. The investigators will test the pressure of airbag, and control the pressure of airbag from 30-40cmHg. 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 CTI group, the tube will be removed after 3-4 weeks. If anastomotic leakage occurred, the investigators will test the airbag pressure and keep the pressure during 30-40cmHg. Because with time went on, the ileum will dilated , the airbag pressure will go down, then the feces may go through the airbag plane and flow into colon and the tube ileostomy will lose its defunctioning effect.When the investigators control the airbag pressure, we can control the defunctioning effect of tube stomy. So it is called controllable tube ileostomy. The investigators will keep the tube 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, Low Anterior Resection
Keywords
Low anterior resection, Anastomotic leakage, Defunctioning stoma, Controllable tube ileostomy, Loop ileostomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controllable tube ileostomy
Arm Type
Experimental
Arm Description
After LAR, the experimental group accepted controllable tube ileostomy.
Arm Title
Loop ileostomy
Arm Type
Active Comparator
Arm Description
After LAR, the experimental group accepted loop ileostomy.
Intervention Type
Device
Intervention Name(s)
Low anterior resection
Intervention Type
Device
Intervention Name(s)
tube ileostomy
Intervention Type
Device
Intervention Name(s)
loop ileostomy
Intervention Type
Device
Intervention Name(s)
accept reversal operation
Intervention Type
Device
Intervention Name(s)
remove the tube ileostomy
Primary Outcome Measure Information:
Title
anastomotic leakage
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.
Time Frame
about in 3 months after operaion
Title
reoperation rate
Description
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 3 months after operation
Title
mortality
Time Frame
about 3 months after operation
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 CTI group, ileus maybe caused by the cannula obstruction.
Time Frame
during the follow time(about 6 months after operaion)
Title
operation data
Description
including operation method, time, blood loss et al.
Time Frame
durting the operation time (about 1-5 h)
Other Pre-specified Outcome Measures:
Title
hospital stays
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)
Title
hospital 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 Patients Agreed to Undergo the tube ileostomy or loop ileostomy Procedure Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hua Hanju, Doctor
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
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

Plan to Share IPD
Yes

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Use of One Kind of Controllable Tube Ileostomy in the Low Rectal Cancer

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