Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer

Not Applicable

• Conditions: Rectal Neoplasms
• Interventions: Device: cannula ileostomy; Device: loop ileostomy; Device: LAR

• Registration Number: NCT01980238
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2013-10-23
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-08
• Last Update Submitted: 2013-11-16
• Last Update Posted: 2013-11-19
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cannula ileostomy	cannula ileostomy	After LAR, experimental group will accept cannula ileostomy. Operation has described in the Detailed Description.
cannula ileostomy	LAR	After LAR, experimental group will accept cannula ileostomy. Operation has described in the Detailed Description.
loop ileostomy	loop ileostomy	After LAR, active comparator group will accept loop ileostomy. This operation is well known by colorectal surgeons.
loop ileostomy	LAR	After LAR, active comparator group will accept loop ileostomy. This operation is well known by colorectal surgeons.

Primary Outcome Measures

Name	Time	Method
anastomotic leakage, reoperation and mortality rate	about in 3 months after operaion.	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. 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.

Secondary Outcome Measures

Name	Time	Method
ileus rate	during the follow time(about 6 months after operaion)	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 cannula ileostomy group, ileus maybe caused by the cannula obstruction.

Trial Locations

Locations (1)

Department of Colorectal Surgery, First Affiliated Hospital, Zhejiang University; 🇨🇳 Hangzhou,, Zhejiang, China