Rectal NeoplasmsCTINCT02012023
Use of One Kind of Controllable Tube Ileostomy in the Low Rectal Cancer
A study testing Low anterior resection, tube ileostomy and loop ileostomy in people with Rectal Neoplasms and Low Anterior Resection, 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 low anterior resections(LAR). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Neoplasms, Low Anterior Resection
- What is being tested?
- Low anterior resection, tube ileostomy and loop ileostomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Aug 2016
- 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
- Patients Agreed to Undergo the tube ileostomy or loop ileostomy Procedure
Who cannot join
- Bowel Preparation is not Satisfied Before Operation
- Blood lose is more than 1500ml during operation
- Critical incident during operation
- The vagina or bladder is seriously damaged and the fix is not satisfied.
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: Use of One Kind of Controllable Tube Ileostomy to Protect Anastomotic Leakage in the Low 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 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.
In fact when we told the patients about the tube ileustomy's effect and risk, almost all the almost all of my patients like to choose tube ileustomy(I have study this method for long time and have good expeience, and my patients either choose tube ileostomy directly or let me do the choice.) So I gave all the patients who meet the requirenments all tube ileustomy and have no control group.
Read the detailed description
After low anterior resection(LAR), 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 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.
- Conditions
- Rectal Neoplasms, Low Anterior Resection
- Being tested
- Low anterior resection, tube ileostomy, loop ileostomy, accept reversal operation, remove the tube ileostomy
- Keywords
- Low anterior resection, Anastomotic leakage, Defunctioning stoma, Controllable tube 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.
Low anterior resectionDevice
tube ileostomyDevice
loop ileostomyDevice
accept reversal operationDevice
remove the tube ileostomyDevice
| Study group | Role | What they receive |
|---|---|---|
| Controllable tube ileostomy | Experimental | After LAR, the experimental group accepted controllable tube ileostomy. Receives: Device: Low anterior resection; Device: tube ileostomy; Device: remove the tube ileostomy |
| Loop ileostomy | Active comparator | After LAR, the experimental group accepted loop ileostomy. Receives: Device: Low anterior resection; Device: loop ileostomy; Device: accept reversal operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
anastomotic leakage
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.
Measured: about in 3 months after operaion
reoperation rate
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 3 months after operation
mortality
Measured: about 3 months after operation
Secondary outcomes (2)
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 CTI group, ileus maybe caused by the cannula obstruction.
Measured: during the follow time(about 6 months after operaion)
operation data
including operation method, time, blood loss et al.
Measured: durting the operation time (about 1-5 h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionAug 2016
- Study completionAug 2016
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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
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
- Investigators
- Hua Hanju, Doctor, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012023
- Sponsor's protocol ID
- Controllable tube ileostomy
- Acronym
- CTI
- Status last verified
- Jul 2016
- First submitted
- 4 Dec 2013
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of One Kind of Controllable Tube Ileostomy to Protect Anastomotic Leakage in the Low Rectal Cancer.
- ClinicalTrials.gov ID
- NCT02012023
- Acronym / sponsor ID
- CTI / Controllable tube ileostomy
- Conditions
- Rectal Neoplasms, Low Anterior Resection
- Keywords
- Low anterior resection, Anastomotic leakage, Defunctioning stoma, Controllable tube ileostomy, Loop ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 16 Dec 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 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.
In fact when we told the patients about the tube ileustomy's effect and risk, almost all the almost all of my patients like to choose tube ileustomy(I have study this method for long time and have good expeience, and my patients either choose tube ileostomy directly or let me do the choice.) So I gave all the patients who meet the requirenments all tube ileustomy and have no control group.
Detailed description
After low anterior resection(LAR), 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controllable tube ileostomy | Experimental | Device: Low anterior resection, Device: tube ileostomy, Device: remove the tube ileostomyAfter LAR, the experimental group accepted controllable tube ileostomy. |
| Loop ileostomy | Active comparator | Device: Low anterior resection, Device: loop ileostomy, Device: accept reversal operationAfter LAR, the experimental group accepted loop ileostomy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Rectal Tumor After Low Anterior Resection the Anastomosis Located extraperitoneal
- Patients Agreed to Undergo the tube ileostomy or loop ileostomy Procedure
Key exclusion criteria (4 listed)
- Bowel Preparation is not Satisfied Before Operation
- Blood lose is more than 1500ml during operation
- Critical incident during operation
- The vagina or bladder is seriously damaged and the fix is not satisfied.
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 |
|---|---|---|
| Low anterior resection | Device | Controllable tube ileostomy, Loop ileostomy |
| tube ileostomy | Device | Controllable tube ileostomy |
| loop ileostomy | Device | Loop ileostomy |
| accept reversal operation | Device | Loop ileostomy |
| remove the tube ileostomy | Device | Controllable tube ileostomy |
Primary outcome
anastomotic leakage
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.
reoperation rate
Time frame: about 3 months after operation
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
2 secondary outcomes
ileus rate
Time frame: during the follow time(about 6 months after operaion)
operation data
Time frame: durting the operation time (about 1-5 h)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Individual participant dataSharing planned: Yes
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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.
Hua Hanju, Doctor principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low anterior resection, tube ileostomy and loop ileostomy in people with Rectal Neoplasms and Low Anterior Resection, 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 23 Aug 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: about in 3 months after operaion). The study lists 3 primary outcomes in all. 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 23 Aug 2016.