Rectal CancerNCT03144765
Multicenter Phase II Study of Transanal TME (taTME)
A study testing Transanal Total Mesorectal Excision (taTME) in people with Rectal Cancer and Surgery, run by Icahn School of Medicine at Mount Sinai at 12 sites in 2 countries.
Trial summary
Radical rectal cancer resection, namely total mesorectal excision (TME), is the cornerstone of the treatment of resectable rectal cancer. In combination with chemotherapy and radiation treatment (CRT), complete TME with negative resection margins is associated with sustained local and systemic control even in locally… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Surgery
- What is being tested?
- Transanal Total Mesorectal Excision (taTME)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 25 Sep 2017to 12 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- New diagnosis of histologically confirmed adenocarcinoma of the rectum
- Age ≥18
- Clinical stage cT1 (high-risk), T2, or T3, cN0, N1, N2 on staging pelvic MRI
- Negative predicted CRM on staging pelvic MRI
- No evidence of metastasis on CT scans of the chest, abdomen and pelvis
- Rectal cancer located within 10 cm from the anal verge based on proctoscopy and digital rectal examination (DRE)
Show all 10Show fewer
- Complete preoperative colonoscopy demonstrating no synchronous colon cancer
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
- Eligible to undergo laparoscopic or robotic LAR with or without a temporary diverting stoma, based on multidisciplinary tumor board consensus
- Able to understand and willing to sign a written informed consent form
Who cannot join
- cT4 on staging pelvic MRI
- >12 weeks delay between completion of neoadjuvant CRT and planned study procedure
- Severely symptomatic rectal tumors
- Tumors invading into the internal anal sphincter muscle based on DRE and pelvic MRI
- Fecal incontinence at baseline
- Prior history of rectal resection
Show all 11Show fewer
- Prior history of colorectal cancer
- History of inflammatory bowel disease
- Uncontrolled concurrent illness
- Pregnancy
- Subjects who cannot read or understand English
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Kaiser Permanente
Los Angeles, California, 90027
Cedars Sinai Medical Center
Los Angeles, California, 90048
Mount Sinai Beth Israel
New York, New York, 10003
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
UC Irvine Hospital
Orange, California, 92868
Florida Hospital
Orlando, Florida, 32804
Providence Portland Medical Center
Portland, Oregon, 97213
Cleveland Clinic Florida
Weston, Florida, 33331
University of Massachusetts
Worcester, Massachusetts, 01605
Lankenau Institute
Wynnewood, Pennsylvania, 19096
About this study
Official title: Multicenter Phase II Study of Transanal Total Mesorectal Excision (taTME) With Laparoscopic Assistance for Rectal Cancer
Radical rectal cancer resection, namely total mesorectal excision (TME), is the cornerstone of the treatment of resectable rectal cancer. In combination with chemotherapy and radiation treatment (CRT), complete TME with negative resection margins is associated with sustained local and systemic control even in locally advanced disease. Over the last 2 decades, laparoscopic and robotic techniques have been increasingly adopted due to reduced surgical trauma and faster patient recovery. Yet, both approaches are associated with equivalent postoperative morbidity and disturbances in sexual, urinary and defecatory function relative to open TME. Furthermore, laparoscopic and robotic TME remain associated with substantial conversion rates and variable rates of TME completeness as a result of the procedural difficulties reaching the low rectum from the abdominal approach. Transanal TME (taTME) with laparoscopic assistance was developed to facilitate completion of TME using a primary transanal endoscopic approach. Transanal TME uses a "bottom-up approach" to overcome the technical difficulties of low pelvic dissection using an abdominal approach. Published results from single-center taTME series and an international registry suggest the short-term procedural and oncologic safety of this approach in resectable rectal cancer. No multicenter phase II study has yet been conducted to validate the procedural safety, functional outcomes or long-term oncologic outcomes of this approach.
Study Design: This is a 5-year phase II multicenter single-arm study to evaluate the safety and efficacy of low anterior resection (LAR) with taTME using laparoscopic or robotic assistance in 100 eligible subjects with resectable rectal cancer.
Hypothesis: taTME is non-inferior to standard LAR with respect to the quality of the TME achieved.
Read the detailed description
The management of rectal cancer is multidisciplinary and outcomes are dependent on accurate preoperative staging, performance of a curative resection, and the selective use of neoadjuvant and adjuvant therapy to improve long-term oncologic outcomes. Despite the increasing use of laparoscopic and robotic approaches, radical rectal cancer resection is associated with relatively high rates of conversion to open surgery, variable rates of TME specimen completeness, and morbidity rates that are equivalent to that of open TME with respect to infectious and wound-related complications, as well as defecatory, sexual and urinary dysfunction,.
Transanal TME (taTME) with laparoscopic assistance was developed in an effort to facilitate completion of TME using a primarily transanal endoscopic approach. Based on the preliminary results from several published single-center case series and the first international taTME registry, in carefully selected patients with resectable rectal cancer, taTME with laparoscopic assistance is associated with perioperative outcomes and short-term oncologic outcomes that are equivalent to that of standard TME.
This study is the first phase II multicenter trial of taTME conducted in the United States to evaluate the efficacy and safety of taTME with laparoscopic or robotic assistance relative to standard LAR. A total of 100 subjects with resectable rectal cancer located up to 10 cm from the anal verge will be enrolled across 10 US study sites. It is anticipated that this larger, phase II multicenter study will validate the safety and efficacy of taTME with respect to perioperative outcomes, short and long-term oncologic outcomes and functional results.
Study procedure:
Study procedures will consist in 1-team (sequential) or 2-team (combined) LAR with transanal TME using laparoscopic or robotic abdominal assistance. Laparoscopic or robotic abdominal access will be obtained followed by inferior mesenteric vessels transection, mobilization or the proximal colon and splenic flexure takedown if indicated. Transanal TME is performed either at the same time or following the above steps. Intersphincteric resection (ISR) may be included for very low tumors. Following pursestring closure of the rectum below the tumor, transanal endoscopic TME dissection will proceed circumferentially until the peritoneal cavity is entered anteriorly. Following complete mobilization of the rectosigmoid, the specimen is extracted transanally or transabdominally followed by colorectal or coloanal anastomosis, with or without a diverting loop ileostomy. Operative details will be recorded in case report forms (CRF's).
TME pathology assessment:
Resected specimens will be processed and analyzed by the participating institution's Pathology Department according to standard TME protocol. De-identified photographs of all fresh TME specimens will be independently reviewed by a Pathology Review Committee blinded to the source of the specimen.
Postoperative care and follow-up:
Subjects will be managed according to standard postoperative protocols. Postoperative visits and oncology follow-up visits will occur as per standard practice and oncologic outcomes. All adverse events occurring during the study period will be graded using the Clavien-Dindo system. Postoperative functional questionnaires will be obtained 6-8 months and 12-14 months postoperatively in non-diverted subjects. In diverted subjects, functional questionnaires will be collected 3-4 months and 9-10 months following ileostomy closure (or 12-18 months following the study procedure).
- Conditions
- Rectal Cancer, Surgery
- Being tested
- Transanal Total Mesorectal Excision (taTME)
- Keywords
- taTME, Transanal, Rectal cancer, Colorectal, Total mesorectal excision, 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.
Transanal Total Mesorectal Excision (taTME)Procedure or surgery
Also called taTME
Study procedures consist in 1-team (sequential) or 2-team (combined) low anterior resection with transanal TME using laparoscopic or robotic abdominal assistance.
| Study group | Role | What they receive |
|---|---|---|
| taTME | Experimental | Enrolled subjects will undergo the study procedure, laparoscopically-assisted Transanal Total Mesorectal Excision (taTME). Receives: Procedure: Transanal Total Mesorectal Excision (taTME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Mesorectal Excision
Rate of complete and near-complete mesorectal excision achieved with taTME, based on standard pathologic assessment of TME specimens.
Measured: 30 days
Secondary outcomes (10)
Complete pathology assessment of TME specimens
TNM grading, margins assessment
Measured: 30 days
30-day perioperative complications
The rate of complications experienced intraoperatively and postoperatively (within 30 days of the study procedure)
Measured: 30 days
Long-term postoperative complications
Incidence of long-term term postoperative complications
Measured: 12 months
Change in COREFO scores
Alterations in Colorectal Functional Outcome Questionnaire (COREFO) scores from baseline up to 18 months postoperatively - 27 items. All questions can be answered by choosing from five response options; No; Never; Yes, less than once a week; Yes, 1-2 days per week; Yes, 3-5 days per week; Yes, 6-7 days per week.
Measured: 18 months
Change in FIQLscores
Alterations in Fecal Incontinence Quality of Life Instrument (FIQL) scores from baseline up to 18 months postoperatively - 29 items range from 1 (strongly agree) to 4 (strongly disagree); with a 1 indicating a lower functional status of quality of life. Scale scores are only calculated if at least half of the items have been answered.
Measured: 18 months
Change in Wexner score
Alterations in Wexner score from baseline up to 18 months postoperatively. Wexner questionnaire - 5 questions and scored from 0 = never to 4= always, with total score from 0 (no incontinence) to 20 (complete incontinence)
Measured: 18 months
Change in International Index of Erectile Function [IIEF] score
Alterations in IIEF scores from baseline up to 18 months postoperatively - 15 item questionnaire, each item range from 0 - 5, with total score to 30. lower score indicates more severe erectile dysfunction (ED)
Measured: 18 months
Change in Female Sexual Function Index [FSFI]
Alterations in FSFI from baseline up to 18 months postoperatively - 19-item self-report measure, each item ranges from 0-5, with full range from 2 to 36, with low score indicating sexual function disorder.
Measured: 18 months
Change in IPSS
Alterations in International Prostate Symptom Score (IPSS) from baseline up to 18 months postoperatively - IPSS 8 questions total - 7 questions related to symptoms, each item scored 1-5. (asymptomatic to very symptomatic). The 8th question refers to the patient's perceived quality of life ranged from 0 to 6 ("delighted" to "terrible".) Total scale ranges from 8-35. Mild (symptom score less than of equal to 7), Moderate (symptom score range 8-19), Severe (symptom score range 20-35).
Measured: 18 months
3-year oncologic outcomes
3-year local recurrence rate, distant recurrence rate, disease-free survival and overall survival
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start25 Sep 2017
- Primary completion2 May 2022
- Study completion12 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Icahn School of Medicine at Mount SinaiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Society of American Gastrointestinal and Endoscopic Surgeons, Research Foundation of the American Society of Colon and Rectal Surgeons
- Responsible party
- Principal investigator, Patricia Sylla, Icahn School of Medicine at Mount Sinai
- Investigators
- Patricia Sylla, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144765
- Sponsor's protocol ID
- GCO 16-2009
- Status last verified
- Apr 2026
- First submitted
- 5 May 2017
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Donovan KF, Carmichael H, Chadi S, Ricardo A, Bonaccorso A, Tomada EP, Sands D, Marks J, Maykel J, Alavi K, Zaghiyan K, Whiteford M, McLemore EC, Shawki SF, Steele S, Pigazzi A, Albert M, DeBeche-Adams T, Avery L, Wexner S, Sylla P. Long-term Results of the North American Phase II Transanal Total Mesorectal Excision Multicenter Trial for Rectal Cancer. Ann Surg. 2026 Aug 1;284(2):236-243. doi: 10.1097/SLA.0000000000007044. Epub 2026 Mar 3.
PubMed 41773887Sylla P, Sands D, Ricardo A, Bonaccorso A, Polydorides A, Berho M, Marks J, Maykel J, Alavi K, Zaghiyan K, Whiteford M, Mclemore E, Chadi S, Shawki SF, Steele S, Pigazzi A, Albert M, DeBeche-Adams T, Moshier E, Wexner SD. Multicenter phase II trial of transanal total mesorectal excision for rectal cancer: preliminary results. Surg Endosc. 2023 Dec;37(12):9483-9508. doi: 10.1007/s00464-023-10266-9. Epub 2023 Sep 12.
PubMed 37700015
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Study of Transanal Total Mesorectal Excision (taTME) With Laparoscopic Assistance for Rectal Cancer
- ClinicalTrials.gov ID
- NCT03144765
- Acronym / sponsor ID
- GCO 16-2009
- Conditions
- Rectal Cancer, Surgery
- Keywords
- taTME, Transanal, Rectal cancer, Colorectal, Total mesorectal excision, TME
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Society of American Gastrointestinal and Endoscopic Surgeons, Research Foundation of the American Society of Colon and Rectal Surgeons
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 12 Apr 2027 (estimated)
- First posted
- 9 May 2017 (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.
Radical rectal cancer resection, namely total mesorectal excision (TME), is the cornerstone of the treatment of resectable rectal cancer. In combination with chemotherapy and radiation treatment (CRT), complete TME with negative resection margins is associated with sustained local and systemic control even in locally advanced disease. Over the last 2 decades, laparoscopic and robotic techniques have been increasingly adopted due to reduced surgical trauma and faster patient recovery. Yet, both approaches are associated with equivalent postoperative morbidity and disturbances in sexual, urinary and defecatory function relative to open TME. Furthermore, laparoscopic and robotic TME remain associated with substantial conversion rates and variable rates of TME completeness as a result of the procedural difficulties reaching the low rectum from the abdominal approach. Transanal TME (taTME) with laparoscopic assistance was developed to facilitate completion of TME using a primary transanal endoscopic approach. Transanal TME uses a "bottom-up approach" to overcome the technical difficulties of low pelvic dissection using an abdominal approach. Published results from single-center taTME series and an international registry suggest the short-term procedural and oncologic safety of this approach in resectable rectal cancer. No multicenter phase II study has yet been conducted to validate the procedural safety, functional outcomes or long-term oncologic outcomes of this approach.
Study Design: This is a 5-year phase II multicenter single-arm study to evaluate the safety and efficacy of low anterior resection (LAR) with taTME using laparoscopic or robotic assistance in 100 eligible subjects with resectable rectal cancer.
Hypothesis: taTME is non-inferior to standard LAR with respect to the quality of the TME achieved.
Detailed description
The management of rectal cancer is multidisciplinary and outcomes are dependent on accurate preoperative staging, performance of a curative resection, and the selective use of neoadjuvant and adjuvant therapy to improve long-term oncologic outcomes. Despite the increasing use of laparoscopic and robotic approaches, radical rectal cancer resection is associated with relatively high rates of conversion to open surgery, variable rates of TME specimen completeness, and morbidity rates that are equivalent to that of open TME with respect to infectious and wound-related complications, as well as defecatory, sexual and urinary dysfunction,.
Transanal TME (taTME) with laparoscopic assistance was developed in an effort to facilitate completion of TME using a primarily transanal endoscopic approach. Based on the preliminary results from several published single-center case series and the first international taTME registry, in carefully selected patients with resectable rectal cancer, taTME with laparoscopic assistance is associated with perioperative outcomes and short-term oncologic outcomes that are equivalent to that of standard TME.
This study is the first phase II multicenter trial of taTME conducted in the United States to evaluate the efficacy and safety of taTME with laparoscopic or robotic assistance relative to standard LAR. A total of 100 subjects with resectable rectal cancer located up to 10 cm from the anal verge will be enrolled across 10 US study sites. It is anticipated that this larger, phase II multicenter study will validate the safety and efficacy of taTME with respect to perioperative outcomes, short and long-term oncologic outcomes and functional results.
Study procedure:
Study procedures will consist in 1-team (sequential) or 2-team (combined) LAR with transanal TME using laparoscopic or robotic abdominal assistance. Laparoscopic or robotic abdominal access will be obtained followed by inferior mesenteric vessels transection, mobilization or the proximal colon and splenic flexure takedown if indicated. Transanal TME is performed either at the same time or following the above steps. Intersphincteric resection (ISR) may be included for very low tumors. Following pursestring closure of the rectum below the tumor, transanal endoscopic TME dissection will proceed circumferentially until the peritoneal cavity is entered anteriorly. Following complete mobilization of the rectosigmoid, the specimen is extracted transanally or transabdominally followed by colorectal or coloanal anastomosis, with or without a diverting loop ileostomy. Operative details will be recorded in case report forms (CRF's).
TME pathology assessment:
Resected specimens will be processed and analyzed by the participating institution's Pathology Department according to standard TME protocol. De-identified photographs of all fresh TME specimens will be independently reviewed by a Pathology Review Committee blinded to the source of the specimen.
Postoperative care and follow-up:
Subjects will be managed according to standard postoperative protocols. Postoperative visits and oncology follow-up visits will occur as per standard practice and oncologic outcomes. All adverse events occurring during the study period will be graded using the Clavien-Dindo system. Postoperative functional questionnaires will be obtained 6-8 months and 12-14 months postoperatively in non-diverted subjects. In diverted subjects, functional questionnaires will be collected 3-4 months and 9-10 months following ileostomy closure (or 12-18 months following the study procedure).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| taTME | Experimental | Procedure: Transanal Total Mesorectal Excision (taTME)Enrolled subjects will undergo the study procedure, laparoscopically-assisted Transanal Total Mesorectal Excision (taTME). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- New diagnosis of histologically confirmed adenocarcinoma of the rectum
- Age ≥18
- Clinical stage cT1 (high-risk), T2, or T3, cN0, N1, N2 on staging pelvic MRI
- Negative predicted CRM on staging pelvic MRI
- No evidence of metastasis on CT scans of the chest, abdomen and pelvis
Key exclusion criteria (11 listed)
- cT4 on staging pelvic MRI
- >12 weeks delay between completion of neoadjuvant CRT and planned study procedure
- Severely symptomatic rectal tumors
- Tumors invading into the internal anal sphincter muscle based on DRE and pelvic MRI
- Fecal incontinence at baseline
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 Excision (taTME)Also: taTMEStudy procedures consist in 1-team (sequential) or 2-team (combined) low anterior resection with transanal TME using laparoscopic or robotic abdominal assistance. | Procedure or surgery | taTME |
Primary outcome
Quality of Mesorectal Excision
Time frame: 30 days
Rate of complete and near-complete mesorectal excision achieved with taTME, based on standard pathologic assessment of TME specimens.
10 secondary outcomes
Complete pathology assessment of TME specimens
Time frame: 30 days
30-day perioperative complications
Time frame: 30 days
Long-term postoperative complications
Time frame: 12 months
Change in COREFO scores
Time frame: 18 months
Change in FIQLscores
Time frame: 18 months
Change in Wexner score
Time frame: 18 months
Change in International Index of Erectile Function [IIEF] score
Time frame: 18 months
Change in Female Sexual Function Index [FSFI]
Time frame: 18 months
Change in IPSS
Time frame: 18 months
3-year oncologic outcomes
Time frame: 3-5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Derived from this study: PubMed 41773887Donovan KF, Carmichael H, Chadi S, Ricardo A, Bonaccorso A, Tomada EP, Sands D, Marks J, Maykel J, Alavi K, Zaghiyan K, Whiteford M, McLemore EC, Shawki SF, Steele S, Pigazzi A, Albert M, DeBeche-Adams T, Avery L, Wexner S, Sylla P. Long-term Results of the North American Phase II Transanal Total Mesorectal Excision Multicenter Trial for Rectal Cancer. Ann Surg. 2026 Aug 1;284(2):236-243. doi: 10.1097/SLA.0000000000007044. Epub 2026 Mar 3.
- Derived from this study: PubMed 37700015Sylla P, Sands D, Ricardo A, Bonaccorso A, Polydorides A, Berho M, Marks J, Maykel J, Alavi K, Zaghiyan K, Whiteford M, Mclemore E, Chadi S, Shawki SF, Steele S, Pigazzi A, Albert M, DeBeche-Adams T, Moshier E, Wexner SD. Multicenter phase II trial of transanal total mesorectal excision for rectal cancer: preliminary results. Surg Endosc. 2023 Dec;37(12):9483-9508. doi: 10.1007/s00464-023-10266-9. Epub 2023 Sep 12.
- Study description on SAGES websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Patricia Sylla, MD principal investigator
Icahn School of Medicine at Mount Sinai
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanal Total Mesorectal Excision (taTME) in people with Rectal Cancer and Surgery, run by Icahn School of Medicine at Mount Sinai at 12 sites in 2 countries.
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 10 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Quality of Mesorectal Excision (time frame: 30 days). 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 NCT03144765, which also lists 2 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 15 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.