Colonic NeoplasmsPhase 1NCT02752360
Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Intestinal Anastomosis
A Phase 1 study testing Biodegradable Stenting Anastomoses and Double-layer Hand Sutures in people with Colonic Neoplasms and Diverticulosis, Colonic, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Intestinal anastomosis plays an important role in various general surgeries, but the complications such as anastomotic leakage,stenosis and hemorrhage cannot been avoided. Although many ways are put up to solve this problem, there are still many imports need to improve. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonic Neoplasms, Diverticulosis, Colonic, Crohn Disease
- What is being tested?
- Biodegradable Stenting Anastomoses and Double-layer Hand Sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Dec 2018
- Phase
- Phase 1
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with age between 18 - 80 years.
- Patients with operation of end to end anastomosis of colon or small intestine.
- Patients without previous surgery during 3 months.
- Patients who understand the nature of this trial and provide informed consent.
Who cannot join
- Patients with severe cardiopulmonary disease or other severe disease.
- Patients who are psychopath, pregnant, and child without capacity for civil conduct.
- Patients with complete intestinal obstruction.
- Patients with abdominal cavity infection.
- Patients who are treating by drug such as adrenal cortical hormone and immune inhibitors, chemotherapy drugs, radiation and so on.
- Patients who need to accept the anastomosis between rectum and colon.
Show all 9Show fewer
- Patients who are required to accept intestinal anastomosis twice or more.
- Patients who are required to accept the treatment of colostomy.
- other conditions that render a patient unsuitable for the trial as determined by the study investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Guocong Wu, Doctor, +86 13810354857, dr.wuguocong@qq.com
About this study
Official title: Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Surgery of Intestinal Anastomosis: A Multicenter, Prospective Cohort Study
Intestinal anastomosis plays an important role in various general surgeries, but the complications such as anastomotic leakage,stenosis and hemorrhage cannot been avoided. Although many ways are put up to solve this problem, there are still many imports need to improve. Therefore, the Biodegradable Stenting Anastomoses(BSA), which make intestinal anastomosis easily and less complications, have been produced.The major goal of this study is to evaluate the efficacy of Biodegradable Stenting Anastomoses(BSA) for reconstruction in surgery of intestinal anastomosis.
- Conditions
- Colonic Neoplasms, Diverticulosis, Colonic, Crohn Disease
- Being tested
- Biodegradable Stenting Anastomoses, Double-layer Hand Sutures
- Keywords
- intestinal reconstruction, end to end anastomosis
- Medical subject headings
- Colonic Neoplasms, Diverticulosis, Colonic, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodegradable Stenting AnastomosesProcedure or surgery
Biodegradable Stenting Anastomoses(BSA) is a new method and device which helps to make intestinal anastomosis easily. According to the measurement of intestinal canal diameter, chose an appropriate size of BSA and use the Seromuscular layer Purse-string Suture to stitch with an absorbable line (VCP311, Ethicon, Inc.) away from the end 0.5 to 1.0 cm and not knot temporarily, then open and sterilize intestinal canal fully, and place the BSA into the intestinal canal at appropriate position before tightening knot. Last, the interrupted whole layer inversion suture is used to fix.
Double-layer Hand SuturesProcedure or surgery
Double-layer Hand Sutures(DHS)is a surgery way that is to use the single-layer continous Hand Sutures,then Lembert to stitch with an absorbable line (VCP311, Ethicon, Inc.).
| Study group | Role | What they receive |
|---|---|---|
| BSA Group | Experimental | Patients accept the management of Biodegradable Stenting Anastomoses for reconstruction in the surgery of Intestinal Anastomosis Receives: Procedure: Biodegradable Stenting Anastomoses |
| DHS Group | Experimental | Patients accept the management of Double-layer Hand Sutures for reconstruction in the surgery of Intestinal Anastomosis Receives: Procedure: Double-layer Hand Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic Leakage Rate
The patients with anastomotic leakage / the total patients. The definition of anastomotic leakage in this study, is included one of the situation as follows: (1) peritonitis caused by leakage, pelvic abscess without radiologically proven anastomotic leakage were considered as equivalents of clinically anastomotic leakage as defined above.; (2) Discharge of faeces, pus or gas from the abdominal drain; (3) All anastomotic leakages were confirmed by one or more of the following methods such as CT scan, ultrasonography and laparotomy.
Measured: 7-10 Days
Anastomotic Hemorrhage Rate
The patients with anastomotic hemorrhage / the total patients. Anastomotic bleeding was considered gastrointestinal bleeding after surgery, and it ascertains that the bleeding is from anastomosis with endoscopy.
Measured: 2 Weeks
Anastomotic Stenosis Rate
The patients with anastomotic stenosis / the total patients.Anastomotic stenosis which is not caused by tumor in the patients with complete or incomplete intestinal obstruction symptoms.
Measured: 6 Months
Secondary outcomes (4)
Number of participant with abnormal laboratory values
Number of participant with abnormal laboratory values will be record. Laboratory tests include Blood routine/Coagulation/Liver and renal function/Electrolyte/Lipids/OB. Abnormal laboratory values means that values of Laboratory tests beyond the normal values.
Measured: 6 Months
Severe adverse events (SAEs)
Severe adverse events (SAEs) refer to the following conditions: death, life-threatening or permanent or significant disability, permanent functional injury to the organs, hospitalization for emergencies or prolonged hospitalization
Measured: 6 Months
Whether the Biodegradable Stenting Anastomoses be eliminated or not
The enteroscopy will be used to observe whether the Biodegradable Stenting Anastomoses be eliminated from body at 4th weeks after surgery.If Biodegradable Stenting Anastomoses be eliminated, contrast will be filling defect.
Measured: 6 Months
The time of reconstruction in the surgery of Intestinal Anastomosis
The time of reconstruction in the surgery of Intestinal Anastomosis for each group is recorded, which is from the beginning to the ending of Intestinal Anastomosis
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Zhejiang Cancer Hospital
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
- Investigators
- Zhongtao Zhang, Doctor, Study chair, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752360
- Sponsor's protocol ID
- BjFH20160410-1
- Status last verified
- Jun 2017
- First submitted
- 19 Apr 2016
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Surgery of Intestinal Anastomosis: A Multicenter, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02752360
- Acronym / sponsor ID
- BjFH20160410-1
- Conditions
- Colonic Neoplasms, Diverticulosis, Colonic, Crohn Disease
- Keywords
- intestinal reconstruction, end to end anastomosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Zhejiang Cancer Hospital
- Study start
- Apr 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Apr 2016 (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.
Intestinal anastomosis plays an important role in various general surgeries, but the complications such as anastomotic leakage,stenosis and hemorrhage cannot been avoided. Although many ways are put up to solve this problem, there are still many imports need to improve. Therefore, the Biodegradable Stenting Anastomoses(BSA), which make intestinal anastomosis easily and less complications, have been produced.The major goal of this study is to evaluate the efficacy of Biodegradable Stenting Anastomoses(BSA) for reconstruction in surgery of intestinal anastomosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BSA Group | Experimental | Procedure: Biodegradable Stenting AnastomosesPatients accept the management of Biodegradable Stenting Anastomoses for reconstruction in the surgery of Intestinal Anastomosis |
| DHS Group | Experimental | Procedure: Double-layer Hand SuturesPatients accept the management of Double-layer Hand Sutures for reconstruction in the surgery of Intestinal Anastomosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with age between 18 - 80 years.
- Patients with operation of end to end anastomosis of colon or small intestine.
- Patients without previous surgery during 3 months.
- Patients who understand the nature of this trial and provide informed consent.
Key exclusion criteria (9 listed)
- Patients with severe cardiopulmonary disease or other severe disease.
- Patients who are psychopath, pregnant, and child without capacity for civil conduct.
- Patients with complete intestinal obstruction.
- Patients with abdominal cavity infection.
- Patients who are treating by drug such as adrenal cortical hormone and immune inhibitors, chemotherapy drugs, radiation and so on.
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 |
|---|---|---|
| Biodegradable Stenting AnastomosesBiodegradable Stenting Anastomoses(BSA) is a new method and device which helps to make intestinal anastomosis easily. According to the measurement of intestinal canal diameter, chose an appropriate size of BSA and use the Seromuscular layer Purse-string Suture to stitch with an absorbable line (VCP311, Ethicon, Inc.) away from the end 0.5 to 1.0 cm and not knot temporarily, then open and sterilize intestinal canal fully, and place the BSA into the intestinal canal at appropriate position before tightening knot. Last, the interrupted whole layer inversion suture is used to fix. | Procedure or surgery | BSA Group |
| Double-layer Hand SuturesDouble-layer Hand Sutures(DHS)is a surgery way that is to use the single-layer continous Hand Sutures,then Lembert to stitch with an absorbable line (VCP311, Ethicon, Inc.). | Procedure or surgery | DHS Group |
Primary outcome
Anastomotic Leakage Rate
Time frame: 7-10 Days
The patients with anastomotic leakage / the total patients. The definition of anastomotic leakage in this study, is included one of the situation as follows: (1) peritonitis caused by leakage, pelvic abscess without radiologically proven anastomotic leakage were considered as equivalents of clinically anastomotic leakage as defined above.; (2) Discharge of faeces, pus or gas from the abdominal drain; (3) All anastomotic leakages were confirmed by one or more of the following methods such as CT scan, ultrasonography and laparotomy.
Anastomotic Hemorrhage Rate
Time frame: 2 Weeks
The patients with anastomotic hemorrhage / the total patients. Anastomotic bleeding was considered gastrointestinal bleeding after surgery, and it ascertains that the bleeding is from anastomosis with endoscopy.
Anastomotic Stenosis Rate
Time frame: 6 Months
The patients with anastomotic stenosis / the total patients.Anastomotic stenosis which is not caused by tumor in the patients with complete or incomplete intestinal obstruction symptoms.
4 secondary outcomes
Number of participant with abnormal laboratory values
Time frame: 6 Months
Severe adverse events (SAEs)
Time frame: 6 Months
Whether the Biodegradable Stenting Anastomoses be eliminated or not
Time frame: 6 Months
The time of reconstruction in the surgery of Intestinal Anastomosis
Time frame: 1 Day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
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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.
Zhongtao Zhang, Doctor study chair
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biodegradable Stenting Anastomoses and Double-layer Hand Sutures in people with Colonic Neoplasms and Diverticulosis, Colonic, run by Beijing Friendship Hospital 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 4 inclusion and 9 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 20 Jun 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Guocong Wu, Doctor (+86 13810354857, dr.wuguocong@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic Leakage Rate (time frame: 7-10 Days). 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 20 Jun 2017.