Rectal CancerPhase 2NCT02830633
Trial to Evaluate Laparoscopy-assisted Nerve-preserved Total Mesorectal Excision (LNTME) Versus Open TME for Rectal Cancer
A Phase 2 study testing LNTME and OTME in people with Rectal Cancer, run by Anhui Medical University.
Trial summary
The purpose of this study is to determine: (1) whether laparoscopy-assisted nerve-preserved total mesorectal excision (LNTME) is as safe as open TME for rectal cancer, and (2) whether LNTME is more effective for protection of pelvic autonomic nerve function from surgical impairing when comparing to open TME. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- LNTME and OTME
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2020
- Phase
- Phase 2
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients
- From 18 years old to 60 years old
- Normal sexual function
- Tumor located in rectum (defined as 5- to 12-cm from the anal verge)
- Pathological confirmed rectal cancer
- Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual
Show all 9Show fewer
- Tumor size < 5 cm
- ASA score was I-II
- Informed consent was written
Who cannot join
- Distant cancer metastasis
- History of abdominal surgery
- With other type of malignancy
- Preoperative voiding dysfunction
- Preoperative sexual dysfunction
- Refusing to attend this trial
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to determine: (1) whether laparoscopy-assisted nerve-preserved total mesorectal excision (LNTME) is as safe as open TME for rectal cancer, and (2) whether LNTME is more effective for protection of pelvic autonomic nerve function from surgical impairing when comparing to open TME.
- Conditions
- Rectal Cancer
- Being tested
- LNTME, OTME
- Keywords
- laparoscopy, rectal cancer, pelvic autonomic nerve
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNTMEProcedure or surgery
Patients in this group received laparoscopy-assisted nerve-preserved TME for treatment of rectal cancer
OTMEProcedure or surgery
Patients in this group received traditional open TME for treatment of rectal cancer
| Study group | Role | What they receive |
|---|---|---|
| LNTME | Experimental | Laparoscopy-assisted nerve-preserved TME (LNTME) is conducted in rectal cancer patients Receives: Procedure: LNTME |
| OTME | Active comparator | Open TME (OTME) is conducted in rectal cancer patients Receives: Procedure: OTME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications including bleeding, anastomotic leakage, postoperative infection, organ dysfunctions.
Measured: postoperative 30 days
The postoperative sexual function assessed by IIEF questionnaire
Measured: postoperative one year
The postoperative voiding function assessed by IPSS questionnaire.
Measured: postoperative one year
Secondary outcomes (4)
Operative time
Measured: an expected average of 180 minutes
Postoperative deaths
Measured: postoperative 30 days
The length postoperative hospital stay
Measured: an expected average 8 days
C-reactive protein
serum C-reactive protein level after operation
Measured: postoperative 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2016 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Anhui Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han-Hui YAO, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830633
- Sponsor's protocol ID
- LNTME-01
- Status last verified
- Jul 2016
- First submitted
- 12 Jun 2016
- Last updated
- 13 Jul 2016
- Results posted
- No
Publications
He Y, Zhu Z, Liu S, Liu L, Hu B, Wan X, Huang Q. [Effect of anastomotic reinforcing sutures on the incidence of anastomotic leakage after laparoscopic radical resection of rectal cancer: a prospective randomized controlled trial]. Zhonghua Wei Chang Wai Ke Za Zhi. 2018 Apirl 25;21(4):431-436. Chinese.
PubMed 29682715
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Evaluate Laparoscopy-assisted Nerve-preserved Total Mesorectal Excision (LNTME) Versus Open TME for Rectal Cancer
- ClinicalTrials.gov ID
- NCT02830633
- Acronym / sponsor ID
- LNTME-01
- Conditions
- Rectal Cancer
- Keywords
- laparoscopy, rectal cancer, pelvic autonomic nerve
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 13 Jul 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.
The purpose of this study is to determine: (1) whether laparoscopy-assisted nerve-preserved total mesorectal excision (LNTME) is as safe as open TME for rectal cancer, and (2) whether LNTME is more effective for protection of pelvic autonomic nerve function from surgical impairing when comparing to open TME.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LNTME | Experimental | Procedure: LNTMELaparoscopy-assisted nerve-preserved TME (LNTME) is conducted in rectal cancer patients |
| OTME | Active comparator | Procedure: OTMEOpen TME (OTME) is conducted in rectal cancer patients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male patients
- From 18 years old to 60 years old
- Normal sexual function
- Tumor located in rectum (defined as 5- to 12-cm from the anal verge)
- Pathological confirmed rectal cancer
Key exclusion criteria (6 listed)
- Distant cancer metastasis
- History of abdominal surgery
- With other type of malignancy
- Preoperative voiding dysfunction
- Preoperative sexual dysfunction
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 |
|---|---|---|
| LNTMEPatients in this group received laparoscopy-assisted nerve-preserved TME for treatment of rectal cancer | Procedure or surgery | LNTME |
| OTMEPatients in this group received traditional open TME for treatment of rectal cancer | Procedure or surgery | OTME |
Primary outcome
Postoperative complications including bleeding, anastomotic leakage, postoperative infection, organ dysfunctions.
Time frame: postoperative 30 days
The postoperative sexual function assessed by IIEF questionnaire
Time frame: postoperative one year
The postoperative voiding function assessed by IPSS questionnaire.
Time frame: postoperative one year
4 secondary outcomes
Operative time
Time frame: an expected average of 180 minutes
Postoperative deaths
Time frame: postoperative 30 days
The length postoperative hospital stay
Time frame: an expected average 8 days
C-reactive protein
Time frame: postoperative 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Derived from this study: PubMed 29682715He Y, Zhu Z, Liu S, Liu L, Hu B, Wan X, Huang Q. [Effect of anastomotic reinforcing sutures on the incidence of anastomotic leakage after laparoscopic radical resection of rectal cancer: a prospective randomized controlled trial]. Zhonghua Wei Chang Wai Ke Za Zhi. 2018 Apirl 25;21(4):431-436. Chinese.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LNTME and OTME in people with Rectal Cancer, run by Anhui Medical University.
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 9 inclusion and 6 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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Han-Hui HH YAO, M.D. (+86-18956087855, ruoyubaba@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications including bleeding, anastomotic leakage, postoperative infection, organ dysfunctions. (time frame: postoperative 30 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?
On the ClinicalTrials.gov record for NCT02830633, which also lists 1 linked publication.
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 13 Jul 2016.