Rectal CancerNCT02812628
Conventional Laparoscopic APR Versus Laparoscopic APR With Transabdominal Individualized Levator Transection
A study testing LAPR and LAPR-TILT in people with Rectal Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
This study is designed to compare the short-term and long-term benefits between conventional laparoscopic abdominoperineal resection (APR) and laparoscopic APR with transabdominal individualized levator transection (TILT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- LAPR and LAPR-TILT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Jun 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed as having rectal cancer ≤5cm from anal verge by colonoscopy.
- Patients undergoing elective, radial surgery with no distant metastasis.
- Patients with Body Mass Index (BMI) between 18-30kg/m2.
- Patients who agree to undergo standard adjuvant treatment after surgery.
- Patients who have fully understood the aim of the trial and have signed the written informed consent.
Who cannot join
- Patients with distant metastasis, tumor infiltrating to adjacent organs, or recurrent tumors.
- Patients undergoing emergent surgery.
- Pregnant patients.
- Patients with tumors other than rectal tumor.
- Patients with severe comorbid diseases which preclude surgery.
- Patients in bad conditions and do not ameliorate before surgery.
- Patients undergoing other procedures to treat rectal cancer, eg. L-Dixon, L-Hartmann or Parks surgery.
- Patients who refuse to accept standard adjuvant surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine
Shanghai, Shanghai Municipality, 200025
Bo Feng, MD/PhD, 86-21-64370045 ext. 664566, fengbo2022@163.com
About this study
Official title: Randomized Clinical Trial of Conventional Laparoscopic Abdominoperineal Resection (APR) Versus Laparoscopic APR With Transabdominal Individualized Levator Transection for Low Rectal Cancer
This study is designed to compare the short-term and long-term benefits between conventional laparoscopic abdominoperineal resection (APR) and laparoscopic APR with transabdominal individualized levator transection (TILT).
Read the detailed description
In the field of surgical treatment for low rectal cancer, the traditional APR is trapped by the so-called "surgical waist" and associated oncological problems, whereas the spread of extra-levator abdominoperineal resection (ELAPR) is still hindered by its high risk of wound complications and neurovascular injuries. Owing to the advancement of laparoscopic techniques, the investigators developed a laparoscopic APR with TILT procedure. During the procedure, a controlled incision of levators into the ischiorectal fat was performed transabdominally under direct vision; the meeting plane is therefore lowered and the perineal dissection is simplified without changing body position. This technique offers individualized transection of levator muscles, minimizes the risk of wound complications and prevents surgical waist to ensure oncological safety. This clinical trial is designed to evaluate the short-term and long-term benefits of this modified procedure.
- Conditions
- Rectal Cancer
- Being tested
- LAPR, LAPR-TILT
- Keywords
- laparoscopic surgery, abdominoperineal resection, rectal cancer, individualized surgery, levator muscle
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAPRProcedure or surgery
Patients undergoing conventional LAPR, the common surgical procedure to treat low rectal cancer ≤5m from anal verge.
LAPR-TILTProcedure or surgery
Patients undergoing LAPR-TILT, a modified APR procedure that is supposed to be safer and less invasive as compared to the LAPR.
| Study group | Role | What they receive |
|---|---|---|
| Conventional LAPR | Active comparator | Patients undergoing conventional laparoscopic abdominoperineal resection (LAPR). Receives: Procedure: LAPR |
| LAPR-TILT | Experimental | Patients undergoing LAPR with transabdominal individualized levator transection (TILT). Receives: Procedure: LAPR-TILT |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year local recurrence
Measured: 3 years post operation
Secondary outcomes (2)
3-year overall survival
Measured: 3 years post operation
3-year disease-free survival
Measured: 3 years post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startDec 2012
- Primary completionJun 2020 (estimated)
- Study completionJun 2022 (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 Ruijin 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Feng, Ruijin Hospital
- Investigators
- Bo Feng, Ph.D, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812628
- Sponsor's protocol ID
- MISC-APR
- Status last verified
- Jun 2016
- First submitted
- 10 Jun 2016
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Conventional Laparoscopic Abdominoperineal Resection (APR) Versus Laparoscopic APR With Transabdominal Individualized Levator Transection for Low Rectal Cancer
- ClinicalTrials.gov ID
- NCT02812628
- Acronym / sponsor ID
- MISC-APR
- Conditions
- Rectal Cancer
- Keywords
- laparoscopic surgery, abdominoperineal resection, rectal cancer, individualized surgery, levator muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 24 Jun 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.
This study is designed to compare the short-term and long-term benefits between conventional laparoscopic abdominoperineal resection (APR) and laparoscopic APR with transabdominal individualized levator transection (TILT).
Detailed description
In the field of surgical treatment for low rectal cancer, the traditional APR is trapped by the so-called "surgical waist" and associated oncological problems, whereas the spread of extra-levator abdominoperineal resection (ELAPR) is still hindered by its high risk of wound complications and neurovascular injuries. Owing to the advancement of laparoscopic techniques, the investigators developed a laparoscopic APR with TILT procedure. During the procedure, a controlled incision of levators into the ischiorectal fat was performed transabdominally under direct vision; the meeting plane is therefore lowered and the perineal dissection is simplified without changing body position. This technique offers individualized transection of levator muscles, minimizes the risk of wound complications and prevents surgical waist to ensure oncological safety. This clinical trial is designed to evaluate the short-term and long-term benefits of this modified procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional LAPR | Active comparator | Procedure: LAPRPatients undergoing conventional laparoscopic abdominoperineal resection (LAPR). |
| LAPR-TILT | Experimental | Procedure: LAPR-TILTPatients undergoing LAPR with transabdominal individualized levator transection (TILT). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed as having rectal cancer ≤5cm from anal verge by colonoscopy.
- Patients undergoing elective, radial surgery with no distant metastasis.
- Patients with Body Mass Index (BMI) between 18-30kg/m2.
- Patients who agree to undergo standard adjuvant treatment after surgery.
- Patients who have fully understood the aim of the trial and have signed the written informed consent.
Key exclusion criteria (8 listed)
- Patients with distant metastasis, tumor infiltrating to adjacent organs, or recurrent tumors.
- Patients undergoing emergent surgery.
- Pregnant patients.
- Patients with tumors other than rectal tumor.
- Patients with severe comorbid diseases which preclude 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 |
|---|---|---|
| LAPRPatients undergoing conventional LAPR, the common surgical procedure to treat low rectal cancer ≤5m from anal verge. | Procedure or surgery | Conventional LAPR |
| LAPR-TILTPatients undergoing LAPR-TILT, a modified APR procedure that is supposed to be safer and less invasive as compared to the LAPR. | Procedure or surgery | LAPR-TILT |
Primary outcome
3-year local recurrence
Time frame: 3 years post operation
2 secondary outcomes
3-year overall survival
Time frame: 3 years post operation
3-year disease-free survival
Time frame: 3 years post operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Bo Feng, Ph.D principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAPR and LAPR-TILT in people with Rectal Cancer, run by Ruijin 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 5 inclusion and 8 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 24 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Feng, M.D. Ph.D (86-21-64370045, fengbo2022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year local recurrence (time frame: 3 years post operation). 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 24 Jun 2016.