Rectal NeoplasmsNCT01980238
Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer
A study testing cannula ileostomy, loop ileostomy and LAR in people with Rectal Neoplasms, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- cannula ileostomy, loop ileostomy and LAR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Rectal Tumor After Low Anterior Resection the Anastomosis Located extraperitoneal.
- Intraperitoneal Anastomosis Who Used of Glucocorticoid or Accepted Neoadjuvant Chemoradiotherapy.
- Patients Agreed to Undergo the Canula Ileostomy or Loop Ileostomy Procedure
Who cannot join
- 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)
- positive air leakage test
- fractured anastomotic rings
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Colorectal Surgery, First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: Defunctioning Cannula Ileostomy After Lower Anterior Resection of 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 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.
Read the 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.
- Conditions
- Rectal Neoplasms
- Being tested
- cannula ileostomy, loop ileostomy, LAR
- Keywords
- LAR, anastomotic leakage, Cannula ileostomy, loop ileostomy
- Medical subject headings
- Rectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cannula ileostomyDevice
loop ileostomyDevice
LARDevice
Also called Low anterior resection
| Study group | Role | What they receive |
|---|---|---|
| cannula ileostomy | Experimental | After LAR, experimental group will accept cannula ileostomy. Operation has described in the Detailed Description. Receives: Device: cannula ileostomy; Device: LAR |
| loop ileostomy | Active comparator | After LAR, active comparator group will accept loop ileostomy. This operation is well known by colorectal surgeons. Receives: Device: loop ileostomy; Device: LAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
anastomotic leakage, reoperation and mortality rate
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.
Measured: about in 3 months after operaion.
Secondary outcomes (1)
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 cannula ileostomy group, ileus maybe caused by the cannula obstruction.
Measured: during the follow time(about 6 months after operaion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua hanju, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980238
- Sponsor's protocol ID
- cannula ileostomy
- Status last verified
- Nov 2013
- First submitted
- 23 Oct 2013
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer.
- ClinicalTrials.gov ID
- NCT01980238
- Acronym / sponsor ID
- cannula ileostomy
- Conditions
- Rectal Neoplasms
- Keywords
- LAR, anastomotic leakage, Cannula ileostomy, loop ileostomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cannula ileostomy | Experimental | Device: cannula ileostomy, Device: LARAfter LAR, experimental group will accept cannula ileostomy. Operation has described in the Detailed Description. |
| loop ileostomy | Active comparator | Device: loop ileostomy, Device: LARAfter LAR, active comparator group will accept loop ileostomy. This operation is well known by colorectal surgeons. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Rectal Tumor After Low Anterior Resection the Anastomosis Located extraperitoneal.
- Intraperitoneal Anastomosis Who Used of Glucocorticoid or Accepted Neoadjuvant Chemoradiotherapy.
- Patients Agreed to Undergo the Canula Ileostomy or Loop Ileostomy Procedure
Key exclusion criteria (3 listed)
- 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)
- positive air leakage test
- fractured anastomotic rings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cannula ileostomy | Device | cannula ileostomy |
| loop ileostomy | Device | loop ileostomy |
| LARAlso: Low anterior resection | Device | cannula ileostomy, loop ileostomy |
Primary outcome
anastomotic leakage, reoperation and mortality rate
Time frame: 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.
1 secondary outcome
ileus rate
Time frame: during the follow time(about 6 months after operaion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
Related trials for Rectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cannula ileostomy, loop ileostomy and LAR in people with Rectal Neoplasms, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anastomotic leakage, reoperation and mortality rate (time frame: about in 3 months after operaion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2013.