Clinical trial NCT01980238: Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer
Official title: Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Neoplasms
Keywords: LAR
anastomotic leakage
Cannula ileostomy
loop ileostomy
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 anterior resections. Although debate about the use of defunctioning stoma continues, meta-analyses and randomized multicenter trial results support the use of defunctioning stoma in lower anterior resection(LAR). This exploratory study was conducted to evaluate the efficacy and safety of a new diversion method called spontaneously closed cannula ileostomy (SCCI), 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Rectal Tumor After Low Anterior Resection the Anastomosis Located extraperitoneal.
2. Intraperitoneal Anastomosis Who Used of Glucocorticoid or Accepted Neoadjuvant Chemoradiotherapy.
3. Patients Agreed to Undergo the Canula Ileostomy or Loop Ileostomy Procedure

Exclusion Criteria:

1. 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)
2. positive air leakage test
3. fractured anastomotic rings

Primary outcomes:
measure: anastomotic leakage, reoperation and mortality rate
timeFrame: about in 3 months after operaion.
Secondary outcomes:
measure: ileus rate
timeFrame: during the follow time(about 6 months after operaion)
Other outcomes:
measure: hospital stays and costs
timeFrame: from admission time to discharge time(about 7-14days)
Locations:
city: Hangzhou,
country: China
facility: Department of Colorectal Surgery, First Affiliated Hospital, Zhejiang University
state: Zhejiang
Study officials:
References: