Rectal CancerNCT03609710
Application of Left Colic Artery Preservation, Anastomotic Reinforcing Sutures and Transanal Tube in Robotic Low Anterior Resection
A study testing Transanal tube placement, Left colic artery preservation and Anastomotic reinforcing sutures in people with Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the results of combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic Low Anterior Resection for Rectal Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Transanal tube placement, Left colic artery preservation and Anastomotic reinforcing sutures
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 May 2019
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of low rectal cancer; Low rectal cancer was defined by the presence of the inferior pole of the tumor below the peritoneal reflection (in 11 cm from the anal margin)
- Primary tumor has undergone histologically comfirmed rectal adenocarcinoma
- Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2016 revision of the International Union Against Cancer primary tumor, regional nodes, metastasis (TNM) staging system)
- Performance status (ECOG) 0~1
- Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization)
- Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either primary tumor, regional nodes, metastasis (AST) or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
- Written informed consent for participation in the trial.
Who cannot join
- Body mass index (BMI) more than 30 kg/m2
- Serious pre-operative comorbidity, including cardiovascular disease (coronary arteriosclerosis, arrhythmia, heart failure), pulmonary dysfunction (lung emphysema, obstructive lung disease), liver insufficiency (Child-Pugh B or C), renal insufficiency (serum creatinine >2.0 mg/dl), and arterial circulation disturbance (occlusion of arterial vessels of limb in patient's history
- History of accepting abdominal surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jianmin Xu
Shanghai, Shanghai Municipality, 200032
Jianmin Xu, MD, +8613501984869, xujmin@aliyun.com
Wenju Chang, MD, +8613764476150, chang_erich@hotmail.com
About this study
Official title: The Effect of Combined Application of Left Colic Artery Preservation, Anastomotic Reinforcing Sutures and Transanal Tube Placement in Robotic Low Anterior Resection for Rectal Cancer to Prevent Anastomic Leak：A Prospective, Single-center, Randomized Control Trial Study
The purpose of this study is to evaluate the results of combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic Low Anterior Resection for Rectal Cancer.
Read the detailed description
Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer
- Conditions
- Rectal Cancer
- Being tested
- Transanal tube placement, Left colic artery preservation, Anastomotic reinforcing sutures, Robotic surgery
- Keywords
- Low rectal cancer, Robotic surgery, Anastomotic leak
- 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.
Transanal tube placementDevice
Transanual tube placement after anastomosis in low anterior resection for rectal cancer.
Left colic artery preservationProcedure or surgery
Left colic artery preservation during operation for lower rectal cancer
Anastomotic reinforcing suturesProcedure or surgery
Anastomotic reinforcing sutures during operation for lower rectal cancer
Robotic surgeryDevice
Robotic low anterior resection for rectal cancer
| Study group | Role | What they receive |
|---|---|---|
| PSTLAR | Experimental | Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer Receives: Device: Transanal tube placement; Procedure: Left colic artery preservation; Procedure: Anastomotic reinforcing sutures; Device: Robotic surgery |
| NORLAR | Active comparator | Traditional robotic low anterior resection for rectal cancer without left colic artery preservation, anastomotic reinforcing sutures or postoperative transanal tube placement Receives: Device: Robotic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leak rate
Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to re-operation.
Measured: 30 days post operatively
Secondary outcomes (1)
Reoperation rate after anastomotic leak
Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to excrement peritonitis, and re-operation as colostomy
Measured: 30 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Jan 2018
- Primary completion28 Feb 2019 (estimated)
- Study completion30 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609710
- Sponsor's protocol ID
- PSTLAR
- Status last verified
- Jan 2018
- First submitted
- 23 Jul 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Application of Left Colic Artery Preservation, Anastomotic Reinforcing Sutures and Transanal Tube Placement in Robotic Low Anterior Resection for Rectal Cancer to Prevent Anastomic Leak：A Prospective, Single-center, Randomized Control Trial Study
- ClinicalTrials.gov ID
- NCT03609710
- Acronym / sponsor ID
- PSTLAR
- Conditions
- Rectal Cancer
- Keywords
- Low rectal cancer, Robotic surgery, Anastomotic leak
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 30 May 2019 (estimated)
- First posted
- 1 Aug 2018 (actual)
- 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.
The purpose of this study is to evaluate the results of combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic Low Anterior Resection for Rectal Cancer.
Detailed description
Combined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSTLAR | Experimental | Device: Transanal tube placement, Procedure: Left colic artery preservation, Procedure: Anastomotic reinforcing sutures, Device: Robotic surgeryCombined application of left colic artery preservation, anastomotic reinforcing sutures and postoperative transanal tube placement in robotic low anterior resection for rectal cancer |
| NORLAR | Active comparator | Device: Robotic surgeryTraditional robotic low anterior resection for rectal cancer without left colic artery preservation, anastomotic reinforcing sutures or postoperative transanal tube placement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of low rectal cancer; Low rectal cancer was defined by the presence of the inferior pole of the tumor below the peritoneal reflection (in 11 cm from the anal margin)
- Primary tumor has undergone histologically comfirmed rectal adenocarcinoma
- Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2016 revision of the International Union Against Cancer primary tumor, regional nodes, metastasis (TNM) staging system)
- Performance status (ECOG) 0~1
- Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization)
Key exclusion criteria (3 listed)
- Body mass index (BMI) more than 30 kg/m2
- Serious pre-operative comorbidity, including cardiovascular disease (coronary arteriosclerosis, arrhythmia, heart failure), pulmonary dysfunction (lung emphysema, obstructive lung disease), liver insufficiency (Child-Pugh B or C), renal insufficiency (serum creatinine >2.0 mg/dl), and arterial circulation disturbance (occlusion of arterial vessels of limb in patient's history
- History of accepting abdominal surgery
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 |
|---|---|---|
| Transanal tube placementTransanual tube placement after anastomosis in low anterior resection for rectal cancer. | Device | PSTLAR |
| Left colic artery preservationLeft colic artery preservation during operation for lower rectal cancer | Procedure or surgery | PSTLAR |
| Anastomotic reinforcing suturesAnastomotic reinforcing sutures during operation for lower rectal cancer | Procedure or surgery | PSTLAR |
| Robotic surgeryRobotic low anterior resection for rectal cancer | Device | NORLAR, PSTLAR |
Primary outcome
Anastomotic leak rate
Time frame: 30 days post operatively
Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to re-operation.
1 secondary outcome
Reoperation rate after anastomotic leak
Time frame: 30 days post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanal tube placement, Left colic artery preservation and Anastomotic reinforcing sutures in people with Rectal Cancer, run by Fudan 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 7 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 3 Aug 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leak rate (time frame: 30 days post operatively). 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 3 Aug 2018.