Rectal NeoplasmsNCT02252250
Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer
A study testing conventional laparoscopic total mesentery excision and transanal hybrid-laparoscopic total mesentery excision in people with Rectal Neoplasms, run by Third Military Medical University at 1 site in China.
Trial summary
To investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- conventional laparoscopic total mesentery excision and transanal hybrid-laparoscopic total mesentery excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Nov 2020
- 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
- Biopsy-proven adenocarcinoma of the rectum
- Eligible to undergo conventional laparoscopic low anterior resection or transanal hybrid-laparoscopic low anterior resection with or without a temporary diverting stoma
- Node negative (N0), T1 (high risk features), T2 and T3 rectal cancer on pelvic MRI
- Closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic MRI
- Rectal cancer located 3-10 cm from the anal verge
Who cannot join
- Metastasis
- Obstructing rectal cancer
- Synchronous colon cancer
- T4 rectal cancer not treated preoperatively with full-course chemoradiation
- Pregnant or breast-feeding
- Receiving any other study agents
Show all 13Show fewer
- Fecal incontinence
- History of prior colorectal cancer
- History of inflammatory bowel disease
- History of pelvic radiation
- BMI > 40
- Large uterine fibroids
- Uncontrolled intercurrent illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cohort Study of Transanal Laparoscopic Total Mesentery Excision Versus Conventional Laparoscopic Surgery for Rectal Cancer
To investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.
Read the detailed description
Natural orifice transluminal endoscopic surgery (NOTES) give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transanal minimal invasive surgery(TAMIS) for rectal cancer show that such NOTES procedures are feasible and safe. And also, lots of experimental studies and small case series reporting the feasibility of transanal anterior resection with single incision laparoscopic surgery(SILS) port or other devices. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function, sexual function, QOF) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive total mesentery excision for rectal cancer.
- Conditions
- Rectal Neoplasms
- Being tested
- conventional laparoscopic total mesentery excision, transanal hybrid-laparoscopic total mesentery excision
- Keywords
- rectal cancer, laparoscopic, taTME, TME
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional laparoscopic total mesentery excisionProcedure or surgery
Also called LTME
conventional laparoscopic total mesentery excision
transanal hybrid-laparoscopic total mesentery excisionProcedure or surgery
Also called TLTME
transanal laparoscopic total mesentery excision for rectal cancer. Mobilize the rectum from down- to-up. Then, set a single incision laparoscopic surgery (SILS) port at the right-low abdomen to resect the lymph nodes of IMA.
| Study group | Role | What they receive |
|---|---|---|
| conventional laparoscopic | Active comparator | conventional laparoscopic total mesentery excision surgery for rectal cancer. Receives: Procedure: conventional laparoscopic total mesentery excision |
| Transanal hybrid-laparoscopic | Experimental | Transanal hybrid-laparoscopic total mesentery excision surgery for rectal cancer. Receives: Procedure: transanal hybrid-laparoscopic total mesentery excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens.
Lymph nodes number; rate of positive circumferential resection margin(CRM);
Measured: 1-6 years
Secondary outcomes (3)
Incidence of 30-day perioperative complications including intraoperative, and postoperative complications
bleeding, injury of adjacent organs, ileus, leakage, infection
Measured: 0-30 days
Incidence of long-term complications
incision hernia,
Measured: 1-6 years
Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision.
overall survive rate and disease free survive rate of 3 and 5 years; recurrence rate
Measured: 1-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2019
- Study completionNov 2020
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Tong, Third Military Medical University
- Investigators
- Weidong Tong, Prof, Principal investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252250
- Sponsor's protocol ID
- 20141056
- Status last verified
- Nov 2023
- First submitted
- 23 Sep 2014
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Transanal Laparoscopic Total Mesentery Excision Versus Conventional Laparoscopic Surgery for Rectal Cancer
- ClinicalTrials.gov ID
- NCT02252250
- Acronym / sponsor ID
- 20141056
- Conditions
- Rectal Neoplasms
- Keywords
- rectal cancer, laparoscopic, taTME, TME
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 30 Sep 2014 (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.
To investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.
Detailed description
Natural orifice transluminal endoscopic surgery (NOTES) give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transanal minimal invasive surgery(TAMIS) for rectal cancer show that such NOTES procedures are feasible and safe. And also, lots of experimental studies and small case series reporting the feasibility of transanal anterior resection with single incision laparoscopic surgery(SILS) port or other devices. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function, sexual function, QOF) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive total mesentery excision for rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional laparoscopic | Active comparator | Procedure: conventional laparoscopic total mesentery excisionconventional laparoscopic total mesentery excision surgery for rectal cancer. |
| Transanal hybrid-laparoscopic | Experimental | Procedure: transanal hybrid-laparoscopic total mesentery excisionTransanal hybrid-laparoscopic total mesentery excision surgery for rectal cancer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Biopsy-proven adenocarcinoma of the rectum
- Eligible to undergo conventional laparoscopic low anterior resection or transanal hybrid-laparoscopic low anterior resection with or without a temporary diverting stoma
- Node negative (N0), T1 (high risk features), T2 and T3 rectal cancer on pelvic MRI
- Closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic MRI
- Rectal cancer located 3-10 cm from the anal verge
Key exclusion criteria (13 listed)
- Metastasis
- Obstructing rectal cancer
- Synchronous colon cancer
- T4 rectal cancer not treated preoperatively with full-course chemoradiation
- Pregnant or breast-feeding
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 |
|---|---|---|
| conventional laparoscopic total mesentery excisionAlso: LTMEconventional laparoscopic total mesentery excision | Procedure or surgery | conventional laparoscopic |
| transanal hybrid-laparoscopic total mesentery excisionAlso: TLTMEtransanal laparoscopic total mesentery excision for rectal cancer. Mobilize the rectum from down- to-up. Then, set a single incision laparoscopic surgery (SILS) port at the right-low abdomen to resect the lymph nodes of IMA. | Procedure or surgery | Transanal hybrid-laparoscopic |
Primary outcome
Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens.
Time frame: 1-6 years
Lymph nodes number; rate of positive circumferential resection margin(CRM);
3 secondary outcomes
Incidence of 30-day perioperative complications including intraoperative, and postoperative complications
Time frame: 0-30 days
Incidence of long-term complications
Time frame: 1-6 years
Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision.
Time frame: 1-6 years
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 27 Nov 2023.
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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.
Weidong Tong, Prof principal investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical 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 conventional laparoscopic total mesentery excision and transanal hybrid-laparoscopic total mesentery excision in people with Rectal Neoplasms, run by Third Military Medical 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 5 inclusion and 13 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 27 Nov 2023. 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?
Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens. (time frame: 1-6 years). 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 27 Nov 2023.