MedDataX Logo

Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer

NCT ID: NCT01980238

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectal Neoplasms

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

LAR anastomotic leakage Cannula ileostomy loop ileostomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cannula ileostomy

After LAR, experimental group will accept cannula ileostomy. Operation has described in the Detailed Description.

Group Type EXPERIMENTAL

cannula ileostomy

Intervention Type DEVICE

LAR

Intervention Type DEVICE

loop ileostomy

After LAR, active comparator group will accept loop ileostomy. This operation is well known by colorectal surgeons.

Group Type ACTIVE_COMPARATOR

loop ileostomy

Intervention Type DEVICE

LAR

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cannula ileostomy

Intervention Type DEVICE

loop ileostomy

Intervention Type DEVICE

LAR

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Low anterior resection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hua hanju

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Colorectal Surgery, First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

cannula ileostomy

Identifier Type: -

Identifier Source: org_study_id