Use of One Kind of Controllable Tube Ileostomy in the Low Rectal Cancer (CTI)
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.
Low Anterior Resection
Device: Low anterior resection
Device: tube ileostomy
Device: loop ileostomy
Device: accept reversal operation
Device: remove the tube ileostomy
|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.|
- 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 ]
- 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.
- 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.
|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)|
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02012023
|Contact: Hua Hanju, Doctorfirstname.lastname@example.org|
|Contact: Lin Jianjiang, Doctoremail@example.com|
|Department of Colorectal Surgery, First Affiliated Hospital, Zhejiang University|
|Hangzhou,, Zhejiang, China, 310003|
|Principal Investigator:||Hua Hanju, Doctor||Zhejiang University|