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

Use of One Kind of Controllable Tube Ileostomy to Protect Anastomotic Leakage in the Low Rectal Cancer.

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.

Study Overview

• Status: Completed
• Conditions: Rectal Neoplasms; Low Anterior Resection
• Intervention / Treatment: Device: loop ileostomy; Device: Low anterior resection; Device: tube ileostomy; Device: remove the tube ileostomy; Device: accept reversal operation

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou,, Zhejiang, China, 310003
      • Department of Colorectal Surgery, First Affiliated Hospital, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: loop ileostomy; Device: Low anterior resection; Device: accept reversal operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	about in 3 months after operaion
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.	about 3 months after operation
mortality		about 3 months after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	during the follow time(about 6 months after operaion)
operation data	including operation method, time, blood loss et al.	durting the operation time (about 1-5 h)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital stays	In loop ileostomy group, hospital stays and costs include the readmission to close the stoma.	from admission time to discharge time(about 7-14days)
hospital costs	In loop ileostomy group, hospital stays and costs include the readmission to close the stoma.	from admission time to discharge time(about 7-14days)

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Investigators: Principal Investigator: Hua Hanju, Doctor, Zhejiang University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Estimate): August 23, 2016
• Last Update Submitted That Met QC Criteria: August 21, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Anastomotic leakage; Low anterior resection; Defunctioning stoma; Loop ileostomy; Controllable tube ileostomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: Controllable tube ileostomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES