Rectal CancerNOTESvsL-LARNCT02550769
Study of NOTES-TME Versus L-LAR in Rectal Cancer
A study testing TRANSANAL TOTAL MESORECTAL EXCISION and Laparoscopic-LAR in people with Rectal Cancer, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
INTRODUCTION: Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less invasive procedure that responds to some of the limitations of the rectal laparoscopic approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- TRANSANAL TOTAL MESORECTAL EXCISION and Laparoscopic-LAR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2015to Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Patients with rectal cancer stage: cT1-2-3, cN0-1, cM0.
- Tumor equal or below 10 cm from the anal verge, candidates to (ETM) low anterior resection and anastomosis, with or without preoperative chemo-radiotherapy.
- Adenocarcinoma of low or moderate differentiation
- ASA I, II, III.
Who cannot join
- Do not sign informed consent
- Pregnant patients
- Liver cirrhosis
- Undifferentiated adenocarcinoma.
- cT4
- Metastatic disease (M1)
Show all 9Show fewer
- chronic renal failure on dialysis
- ASA IV
- BMI <18 and> 35 kg / m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Low Anterior Resection in Rectal Cancer
INTRODUCTION: Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less invasive procedure that responds to some of the limitations of the rectal laparoscopic approach.
MAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with the same pathological, functional and oncologic results.
METHODOLOGY: A prospective multicenter randomized controlled study of patients with rectal cancer that, were randomized in the T-TME- and L-LAR group. The main variables are: general morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The sample calculation is 58 patients per group.
Read the detailed description
INTRODUCTION: The laparoscopic total mesorectal excision (TME) has provided better patient recovery with less morbidity and shorter hospital stay compared with open surgery. However in laparoscopic low rectal surgery, overall conversion to open surgery is around 20%. Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less invasive procedure that responds to some of the limitations of the rectal laparoscopic approach.
MAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with the same pathological, functional and oncologic results.
METHODOLOGY: A prospective multicenter randomized controlled study of patients diagnosed with adenocarcinoma of the rectum that after inclusion and exclusion criteria, were randomized in the T-TME- and L-LAR group. The main variables are: general morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The other variables studied were: demographic, surgical, pathological, 30-day morbidity and mortality, quality of life and oncologic results. The sample calculation is 53 patients per group. With an estimated loss of 10%, the final number will be 116 patients.
- Conditions
- Rectal Cancer
- Being tested
- TRANSANAL TOTAL MESORECTAL EXCISION, Laparoscopic-LAR
- Keywords
- Transanal NOTES, Transanal TME, Laparoscopic Low Anterior Resection, Surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRANSANAL TOTAL MESORECTAL EXCISIONProcedure or surgery
The technique begins with the TEO equipment and a purse string 1 cm distal to the tumor. The dissection progresses in the posterior part until the laparoscopic TME field is reached. After the section of the rectum and TME transanal dissection, the anvil of the circular mechanical stapler is introduced through the TEO rectoscope. In the laparoscopic field, the mesosigma is sectioned at the point where the colon section is to be performed. The TEO rectoscope is withdrawn, and the bag containing the specimen is removed through the anus. The stapler is inserted. From the laparoscopic field, the strings of the purse are tightened and the purse is closed around the rectal stump with a clip. Then the stapler are joined to perform the anastomosis and a loop ileostomy is placed in the right flank.
Laparoscopic-LARProcedure or surgery
Also called Laparoscopic Low Anterior Resecion of the rectum
Standard laparoscopic low anterior resection of the rectum with total mesorectal excision and colorectal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| TRANSANAL TOTAL MESORECTAL EXCISION | Experimental | Transanal approach of total mesorectal excision. Receives: Procedure: TRANSANAL TOTAL MESORECTAL EXCISION |
| Laparoscopic-LAR | Active comparator | Type of surgical intervention as control group: Laparoscopic low anterior resection with total mesorectal excision for rectal cancer Receives: Procedure: Laparoscopic-LAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of the T-TME versus L-LAR with the Dindo-Claviens classification in patients with rectal cancer.
Evaluate surgical complications 30 days after surgery.
Measured: 30 days
Evaluate the effectiveness of the T-TME versus L-LAR with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CR-30 score in patients with rectal cancer.
Evaluate functional results 6 months after ileostomy closure.
Measured: 6 months
Evaluate the effectiveness of the T-TME versus L-LAR with the EORTC QLQ-CR29 score in patients with rectal cancer.
Evaluate functional results 6 months after ileostomy closure.
Measured: 6 months
Evaluate the effectiveness of the T-TME versus L-LAR with the LARS score in patients with rectal cancer.
Evaluate functional results 6 months after ileostomy closure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Serra-Aracil, Corporacion Parc Tauli
- Investigators
- Serra-Aracil Xavier, MD, PhD, Principal investigator, Corporacio Parc Tauli. Parc Tauli University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550769
- Sponsor's protocol ID
- NOTES-LRAB_TAU-2015
- Acronym
- NOTESvsL-LAR
- Status last verified
- Jul 2020
- First submitted
- 31 Aug 2015
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Serra-Aracil X, Mora-Lopez L, Casalots A, Pericay C, Guerrero R, Navarro-Soto S. Hybrid NOTES: TEO for transanal total mesorectal excision: intracorporeal resection and anastomosis. Surg Endosc. 2016 Jan;30(1):346-54. doi: 10.1007/s00464-015-4170-5. Epub 2015 Mar 27.
PubMed 25814073Serra-Aracil X. [Transanal total mesorectal excision]. Cir Esp. 2014 Apr;92(4):221-2. doi: 10.1016/j.ciresp.2014.01.002. Epub 2014 Feb 24. No abstract available. Spanish.
PubMed 24576748Serra-Aracil X, Gonzalez A, Bargallo J, Serracant A, Roura J, Cayetano-Paniagua L, Delgado S, Zarate A; Ta-LaTME Study Group. Quality of life, bowel dysfunction, and long-term oncological outcomes after transanal versus laparoscopic total mesorectal excision for mid- and low- rectal cancer (Ta-LaTME study): multicentre randomized open-label trial. BJS Open. 2026 Jul 3;10(4):zrag045. doi: 10.1093/bjsopen/zrag045.
PubMed 42551037Serra-Aracil X, Zarate A, Bargallo J, Gonzalez A, Serracant A, Roura J, Delgado S, Mora-Lopez L; Ta-LaTME study Group. Transanal versus laparoscopic total mesorectal excision for mid and low rectal cancer (Ta-LaTME study): multicentre, randomized, open-label trial. Br J Surg. 2023 Jan 10;110(2):150-158. doi: 10.1093/bjs/znac324.
PubMed 36224406Serra-Aracil X, Zarate A, Mora L, Serra-Pla S, Pallisera A, Bonfill J, Bargallo J, Pando A, Delgado S, Balleteros E, Pericay C. Study protocol for a multicenter prospective controlled and randomized trial of transanal total mesorectal excision versus laparoscopic low anterior resection in rectal cancer. Int J Colorectal Dis. 2018 May;33(5):649-655. doi: 10.1007/s00384-018-2996-8. Epub 2018 Mar 16.
PubMed 29546560
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Low Anterior Resection in Rectal Cancer
- ClinicalTrials.gov ID
- NCT02550769
- Acronym / sponsor ID
- NOTESvsL-LAR / NOTES-LRAB_TAU-2015
- Conditions
- Rectal Cancer
- Keywords
- Transanal NOTES, Transanal TME, Laparoscopic Low Anterior Resection, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 16 Sep 2015 (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.
INTRODUCTION: Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less invasive procedure that responds to some of the limitations of the rectal laparoscopic approach.
MAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with the same pathological, functional and oncologic results.
METHODOLOGY: A prospective multicenter randomized controlled study of patients with rectal cancer that, were randomized in the T-TME- and L-LAR group. The main variables are: general morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The sample calculation is 58 patients per group.
Detailed description
INTRODUCTION: The laparoscopic total mesorectal excision (TME) has provided better patient recovery with less morbidity and shorter hospital stay compared with open surgery. However in laparoscopic low rectal surgery, overall conversion to open surgery is around 20%. Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less invasive procedure that responds to some of the limitations of the rectal laparoscopic approach.
MAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with the same pathological, functional and oncologic results.
METHODOLOGY: A prospective multicenter randomized controlled study of patients diagnosed with adenocarcinoma of the rectum that after inclusion and exclusion criteria, were randomized in the T-TME- and L-LAR group. The main variables are: general morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The other variables studied were: demographic, surgical, pathological, 30-day morbidity and mortality, quality of life and oncologic results. The sample calculation is 53 patients per group. With an estimated loss of 10%, the final number will be 116 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRANSANAL TOTAL MESORECTAL EXCISION | Experimental | Procedure: TRANSANAL TOTAL MESORECTAL EXCISIONTransanal approach of total mesorectal excision. |
| Laparoscopic-LAR | Active comparator | Procedure: Laparoscopic-LARType of surgical intervention as control group: Laparoscopic low anterior resection with total mesorectal excision for rectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18 years
- Patients with rectal cancer stage: cT1-2-3, cN0-1, cM0.
- Tumor equal or below 10 cm from the anal verge, candidates to (ETM) low anterior resection and anastomosis, with or without preoperative chemo-radiotherapy.
- Adenocarcinoma of low or moderate differentiation
- ASA I, II, III.
Key exclusion criteria (9 listed)
- Do not sign informed consent
- Pregnant patients
- Liver cirrhosis
- Undifferentiated adenocarcinoma.
- cT4
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 TOTAL MESORECTAL EXCISIONThe technique begins with the TEO equipment and a purse string 1 cm distal to the tumor. The dissection progresses in the posterior part until the laparoscopic TME field is reached. After the section of the rectum and TME transanal dissection, the anvil of the circular mechanical stapler is introduced through the TEO rectoscope. In the laparoscopic field, the mesosigma is sectioned at the point where the colon section is to be performed. The TEO rectoscope is withdrawn, and the bag containing the specimen is removed through the anus. The stapler is inserted. From the laparoscopic field, the strings of the purse are tightened and the purse is closed around the rectal stump with a clip. Then the stapler are joined to perform the anastomosis and a loop ileostomy is placed in the right flank. | Procedure or surgery | TRANSANAL TOTAL MESORECTAL EXCISION |
| Laparoscopic-LARAlso: Laparoscopic Low Anterior Resecion of the rectumStandard laparoscopic low anterior resection of the rectum with total mesorectal excision and colorectal anastomosis | Procedure or surgery | Laparoscopic-LAR |
Primary outcome
Evaluate the effectiveness of the T-TME versus L-LAR with the Dindo-Claviens classification in patients with rectal cancer.
Time frame: 30 days
Evaluate surgical complications 30 days after surgery.
Evaluate the effectiveness of the T-TME versus L-LAR with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CR-30 score in patients with rectal cancer.
Time frame: 6 months
Evaluate functional results 6 months after ileostomy closure.
Evaluate the effectiveness of the T-TME versus L-LAR with the EORTC QLQ-CR29 score in patients with rectal cancer.
Time frame: 6 months
Evaluate functional results 6 months after ileostomy closure.
Evaluate the effectiveness of the T-TME versus L-LAR with the LARS score in patients with rectal cancer.
Time frame: 6 months
Evaluate functional results 6 months after ileostomy closure.
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 16 Nov 2021.
- Background: PubMed 25814073Serra-Aracil X, Mora-Lopez L, Casalots A, Pericay C, Guerrero R, Navarro-Soto S. Hybrid NOTES: TEO for transanal total mesorectal excision: intracorporeal resection and anastomosis. Surg Endosc. 2016 Jan;30(1):346-54. doi: 10.1007/s00464-015-4170-5. Epub 2015 Mar 27.
- Background: PubMed 24576748Serra-Aracil X. [Transanal total mesorectal excision]. Cir Esp. 2014 Apr;92(4):221-2. doi: 10.1016/j.ciresp.2014.01.002. Epub 2014 Feb 24. No abstract available. Spanish.
- Derived from this study: PubMed 42551037Serra-Aracil X, Gonzalez A, Bargallo J, Serracant A, Roura J, Cayetano-Paniagua L, Delgado S, Zarate A; Ta-LaTME Study Group. Quality of life, bowel dysfunction, and long-term oncological outcomes after transanal versus laparoscopic total mesorectal excision for mid- and low- rectal cancer (Ta-LaTME study): multicentre randomized open-label trial. BJS Open. 2026 Jul 3;10(4):zrag045. doi: 10.1093/bjsopen/zrag045.
- Derived from this study: PubMed 36224406Serra-Aracil X, Zarate A, Bargallo J, Gonzalez A, Serracant A, Roura J, Delgado S, Mora-Lopez L; Ta-LaTME study Group. Transanal versus laparoscopic total mesorectal excision for mid and low rectal cancer (Ta-LaTME study): multicentre, randomized, open-label trial. Br J Surg. 2023 Jan 10;110(2):150-158. doi: 10.1093/bjs/znac324.
- Derived from this study: PubMed 29546560Serra-Aracil X, Zarate A, Mora L, Serra-Pla S, Pallisera A, Bonfill J, Bargallo J, Pando A, Delgado S, Balleteros E, Pericay C. Study protocol for a multicenter prospective controlled and randomized trial of transanal total mesorectal excision versus laparoscopic low anterior resection in rectal cancer. Int J Colorectal Dis. 2018 May;33(5):649-655. doi: 10.1007/s00384-018-2996-8. Epub 2018 Mar 16.
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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.
Serra-Aracil Xavier, MD, PhD principal investigator
Corporacio Parc Tauli. Parc Tauli University 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 TRANSANAL TOTAL MESORECTAL EXCISION and Laparoscopic-LAR in people with Rectal Cancer, run by Corporacion Parc Tauli at 1 site in Spain.
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 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: finished, as of the sponsor's last update on 16 Nov 2021. 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 Spain. 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?
Evaluate the effectiveness of the T-TME versus L-LAR with the Dindo-Claviens classification in patients with rectal cancer. (time frame: 30 days). The study lists 4 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 NCT02550769, which also lists 5 linked publications.
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 16 Nov 2021.