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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by First Affiliated Hospital of Zhejiang University
Sponsor:
Collaborators:
Cixi People's Hospital
the Second Hospital of Shaoxing
Lishui People's Hospital
Wenling Hospital of traditional Chinese Medicine
Jinhua Central Hospital
Information provided by (Responsible Party):
Hua hanju, First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier:
NCT02012023
First received: December 4, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Rectal Neoplasms
Low Anterior Resection
Device: Low anterior resection
Device: tube ileostomy
Device: loop ileostomy
Device: accept reversal operation
Device: remove the tube ileostomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Use of One Kind of Controllable Tube Ileostomy to Protect Anastomotic Leakage in the Low Rectal Cancer.

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital of Zhejiang University:

Primary Outcome Measures:
  • anastomotic leakage [ Time Frame: about in 3 months after operaion ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: about 3 months after operation ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: about 3 months after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ileus rate [ Time Frame: during the follow time(about 6 months after operaion) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: durting the operation time (about 1-5 h) ] [ Designated as safety issue: No ]
    including operation method, time, blood loss et al.


Other Outcome Measures:
  • hospital stays [ Time Frame: from admission time to discharge time(about 7-14days) ] [ Designated as safety issue: No ]
    In loop ileostomy group, hospital stays and costs include the readmission to close the stoma.

  • hospital costs [ Time Frame: from admission time to discharge time(about 7-14days) ] [ Designated as safety issue: No ]
    In loop ileostomy group, hospital stays and costs include the readmission to close the stoma.


Estimated Enrollment: 300
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Controllable tube ileostomy
After LAR, the experimental group accepted controllable tube ileostomy.
Device: Low anterior resection Device: tube ileostomy Device: remove the tube ileostomy
Active Comparator: Loop ileostomy
After LAR, the experimental group accepted loop ileostomy.
Device: Low anterior resection Device: loop ileostomy Device: accept reversal operation

Detailed Description:

After low anterior resection(LAR), in the LI group, the operation method was done as surgeons all known. In the CTI 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. 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 LI group, patients accepted reversal operation at least 3 months after operation if operation condition permission.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Positive air leakage test and fractured anastomotic rings
  • Blood lose is more than 1500ml during operation
  • Critical incident during operation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012023

Contacts
Contact: Hua Hanju, Doctor +8615088779188 tomorrow97@163.com
Contact: Lin Jianjiang, Doctor +8613666670218 ljjzju@163.com

Locations
China, Zhejiang
Department of Colorectal Surgery, First Affiliated Hospital, Zhejiang University
Hangzhou,, Zhejiang, China, 310003
Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Cixi People's Hospital
the Second Hospital of Shaoxing
Lishui People's Hospital
Wenling Hospital of traditional Chinese Medicine
Jinhua Central Hospital
Investigators
Principal Investigator: Hua Hanju, Doctor Zhejiang University
  More Information

No publications provided

Responsible Party: Hua hanju, Doctor, First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT02012023     History of Changes
Other Study ID Numbers: Controllable tube ileostomy
Study First Received: December 4, 2013
Last Updated: December 16, 2013
Health Authority: China: Ethics Committee

Keywords provided by First Affiliated Hospital of Zhejiang University:
Low anterior resection
Anastomotic leakage
Defunctioning stoma
Controllable tube ileostomy
Loop ileostomy

Additional relevant MeSH terms:
Rectal Neoplasms
Anastomotic Leak
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014