Rectal CancerLOTARTMENCT04949672
Pathology Assessment of Mesorectal Fascia After TME by Laparoscopic, Open, TransAnal and Robotic Approaches (LOTARTME)
An observational study of Rectal Cancer and Surgery, run by San Giovanni Addolorata Hospital at 1 site in Italy.
Trial summary
TME is the gold standard surgical treatment of rectal cancer. Specimen quality, integrity of mesorectal fascia and lymph nodes harvest are expression of radicality and good surgery. The LOTARTME study is designed to assess which of the open, laparoscopic, robotic and endoscopic transanal approach is superior. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer, Surgery
- How many people
- 153 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2017to 29 Jun 2021
- How long will I take part?
- 4 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Stage 1 and 2 rectal cancer patients (preoperative assessment) undergoing surgery without neoadjuvant chemoradiation therapy. Stage 3 and 4 rectal cancer patients undergoing surgery after long-term or short-term chemoradiation therapy.
Who may be able to join
- intent to treat procedures
- procedures performed by experienced surgeons (minimum of 100 TME)
Who cannot join
- palliation surgery
- multivisceral resections
- procedures performed by inexperienced surgeons (less of 100 TME)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pathology Assessment of Mesorectal Fascia and Specimen Quality After TME by Laparoscopic, Open, TransAnal and Robotic Approaches (LOTARTME)
TME is the gold standard surgical treatment of rectal cancer. Specimen quality, integrity of mesorectal fascia and lymph nodes harvest are expression of radicality and good surgery. The LOTARTME study is designed to assess which of the open, laparoscopic, robotic and endoscopic transanal approach is superior. Primary outcome is the evaluation of completeness of mesorectal fascia according to Quirke classification. Secondary outcomes are lymph nodes harvest, local recurrences, overall survivals, cancer related survivals. Inclusion criteria: any patient of any age and sex undergoing to intent-to-treat surgery operated by experienced surgeon. Exclusion criteria: patients with rectal cancer undergoing palliative surgery or multivisceral resection; all patients operated by less experienced surgeons. Study period January 1, 2017 - June 30 2021 and patients enrollment: January 1, 2017 - December 31, 2020. Data collection and analysis: data are collected in a prospective database and statical analysis is carried out using AnalystSoft StatPlus for Windows Software.
Read the detailed description
Developed in 1992 by Heald Total Mesorectal Excision improved the long-term results of rectal cancer treatment with overall survivals increasing up to 80% and local recurrences decreasing down to 4%. Notwithstanding the introduction of laparoscopy and robotic technology and their application in the field of rectal cancer surgery in the last decades, no further improvement of rectal cancer survivals have been reported. Actually, completeness of mesorectal fat and fascia excision seems not to be improved with these new approaches, compared to standard open surgery. It has been proved that local recurrences are strictly related to the quality of TME and are significantly higher when mesorectal fascia is incomplete according to Quirke classification. In 2012 A. Lacy first reported the transanal approach to TME, developed to overcome the high challenges represented by low rectal dissection when difficult anatomy is present (i.e. obese pts, narrow pelvis, bulging tumors) that may impair the quality of surgical specimen and, therefore, increase the incidence of local recurrences and, indirectly, overall cancer related survivals. There is an ongoing clinical trial (COLOR III) that has been designed to assess whether long term results after TaTME are similar, better or worse than those of open or laparoscopic TME. Until then scientists and researchers may evaluate the effectiveness of TaTME compared to other surgical approaches (open, laparoscopic, robotic) assessing the quality of surgical specimens (i.e. completeness of mesorectal excision and integrity of mesorectal fascia according to Quirke classification). Investigators have designed a prospective observational cohort study assessing the quality of specimen and mesorectal fascia in all patients undergoing TME through an open, laparoscopic, robotic and transanal (TaTME) approach between January 2017 and December 2020. All patients have been followed-up with a required minimum follow-up of 6 months. Therefore, the study was terminated on June 2021. Inclusion criteria were: any patient of any age and sex undergoing intent-to-treat surgery operated by experienced surgeon (with ≥ 100 TME performed). Exclusion criteria: patients with rectal cancer undergoing palliative surgery or multivisceral resection, all patients operated by less experienced surgeons (< 100 TME performed).
Objective of the study:
Assessing the quality of the specimen after TME carried out through laparoscopic, open, robotic and endoscopic transanal approach; evaluating whether TaTME might be superior the other approaches in term of radicality of surgery and local recurrencies.
Primary outcome:
Quirke classification of mesorectal fat and fascia completeness. Three grade classification: complete, nearly complete, incomplete.
Secondary outcomes Lymph node harvest Local recurrences Overall survivals Cancer specific survivals Pathology assessment
A fresh specimen or in vacuum packing is sent for macroscopic assessment to the pathologist. The specimen is dealt as follows:
- assessment of mesorectum quality; 2) ink painting of specimen non-peritonealized bare areas 3) the specimen is opened along the anterior aspect from the top and the bottom, leaving the bowel intact at a level just above and just below the tumour; 4) placement of formalin-soaked gauze wicks into the unopened ends of the bowel; 5) the specimen is fixed in 10% buffered formalin for at least 48 hours.
The fixed specimen is dealt as follows:
- 3-5 mm intervals slices through the unopened rectum; 2) slices inspection to note: extent of tumour and the closest distance of tumour to the Circumferential Resection Margin (CRM); positive nodes and the distance of any positive node to the CRM; anterior, posterior or lateral closest distance of tumour to CRM; 3) lymph nodes detection within the fat away from the tumour
Block selection according to the followings:
- tumor blocks showing closest CRM; 2) tumor blocks showing luminal aspect, 3) all lymph nodes; 4) any polyps; 5) proximal and distal resection margins (distal margin includes both mucosa and mesorectum).
The pathologist examined the specimen in a blinded fashion (unaware of the name of the operating surgeon and the technique performed).
Data are collected in a prospective database. Statistical analysis is carried out with AnalystSoft StatPlus for Windows Software. Chi-square test and chi-square test with Yates correction are used considering p-value significative at p<.05.
- Conditions
- Rectal Cancer, Surgery
- Keywords
- TME, TransAnal TME, Mesorectal Fascia, Rectal Cancer 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.
| Study group | Role | What they receive |
|---|---|---|
| Open TME | Total Mesorectal Excision (TME) is the gold standard surgical treatment of rectal cancer. According to the technique first described by Bill Heald, TME entails the resection of the rectum including the whole mesorectal fat and an intact mesorectal fascia. Open TME is accomplished through a midline xifo-umbilical laparotomy and requires a complete mobilization of the left colon and central ligature of inferior mesenteric artery and vein. | |
| Laparoscopic TME | Laparoscopic TME mirrors the procedure performed through laparotomy with the same operative steps and performing rectal resection including the excision of the surrounding mesorectal fat and fascia. | |
| Robotic TME | Robotic TME mirrors the procedure described by Bill Heald for open surgery but the operation is performed by the master-slave DaVinci System under 3D laparoscopic guidance. The rectal resection is performed including mesorectal fat and fascia. | |
| TransAnal TME | TaTME has first described by Antonio Lacy in 2012. This procedure has two steps: abdominal and perineal. The abdominal step is performed through a laparoscopic approach as described for laparoscopic TME but the caudal dissection is stopped right below the level of the peritoneal rectal reflection (Douglas pouch). The perineal step is accomplished transanally inserting a specially designed platform into the anal canal and performing the total mesorectal excision under endoscopic guidance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness of mesorectal fascia and specimen quality (specimen integrity after rectal resection)
Specimen quality i.e. integrity of mesorectal fascia and clearance of radial margins are an important factor with impact on local recurrency of rectal cancer. the 3-grade Quirke classification is used to assess completeness of mesorectal fascia: complete, nearly complete and incomplete
Measured: 4 years
Secondary outcomes (4)
Lymph node harvest
The number of lymph nodes harvested may influence patient's prognosis and survival. A minimum number of nodes is required to assess the cancer stage correctly: stage 2 rectal cancer with a less than 12 node harvest has a behaviour of a stage 3 rectal cancer in the medium and long term follow up.
Measured: 4 years
Local recurrence
Local recurrence rate is intended the incidence of pelvic tumor recurrence, especially localized in the presacral area, and anastomotic recurrence
Measured: up to 54-month follow-up (range 6-54 months) with a median follow up respectively 54, 39, 38, 39,5 months for the open TME group, for the laparoscopic TME group, for the robotic TME group and for the TaTME group. Overall median FU = 44 months.
Overal survivals
short and medium term survivals (Kaplan-Meier estimate)
Measured: Overall median follow-up 44 months (FU range 6-54 months), median follow-up per study group: Open TME 54 months, Laparoscopic TME 39 months, Robotic TME 38 months, TaTME 39,5 months.
Cancer specific survival (CSS)
Cancer-specific survival (CSS) is defined as the duration from the date of diagnosis until death due to rectal cancer other than other causes
Measured: Overall median follow-up 44 months (FU range 6-54 months), median follow-up per study group: Open TME 54 months, Laparoscopic TME 39 months, Robotic TME 38 months, TaTME 39,5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study startJan 2017
- Primary completionDec 2020
- Study completion29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- San Giovanni Addolorata Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Maria Lirici, San Giovanni Addolorata Hospital
- Investigators
- Marco Maria Lirici, MD, Principal investigator, San Giovanni Addolorata Hospital Complex; Saint Camillus International University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949672
- Sponsor's protocol ID
- SGAddolorataH
- Acronym
- LOTARTME
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barnajian M, Pettet D 3rd, Kazi E, Foppa C, Bergamaschi R. Quality of total mesorectal excision and depth of circumferential resection margin in rectal cancer: a matched comparison of the first 20 robotic cases. Colorectal Dis. 2014 Aug;16(8):603-9. doi: 10.1111/codi.12634.
PubMed 24750995Parfitt JR, Driman DK. The total mesorectal excision specimen for rectal cancer: a review of its pathological assessment. J Clin Pathol. 2007 Aug;60(8):849-55. doi: 10.1136/jcp.2006.043802. Epub 2006 Oct 17.
PubMed 17046842Martellucci J, Bergamini C, Bruscino A, Prosperi P, Tonelli P, Todaro A, Valeri A. Laparoscopic total mesorectal excision for extraperitoneal rectal cancer: long-term results. Int J Colorectal Dis. 2014 Dec;29(12):1493-9. doi: 10.1007/s00384-014-2017-5. Epub 2014 Sep 25.
PubMed 25248320Havenga K, Grossmann I, DeRuiter M, Wiggers T. Definition of total mesorectal excision, including the perineal phase: technical considerations. Dig Dis. 2007;25(1):44-50. doi: 10.1159/000099169.
PubMed 17384507Pai A, Marecik SJ, Park JJ, Melich G, Sulo S, Prasad LM. Oncologic and Clinicopathologic Outcomes of Robot-Assisted Total Mesorectal Excision for Rectal Cancer. Dis Colon Rectum. 2015 Jul;58(7):659-67. doi: 10.1097/DCR.0000000000000385.
PubMed 26200680Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery--the clue to pelvic recurrence? Br J Surg. 1982 Oct;69(10):613-6. doi: 10.1002/bjs.1800691019.
PubMed 6751457Lacy AM, Tasende MM, Delgado S, Fernandez-Hevia M, Jimenez M, De Lacy B, Castells A, Bravo R, Wexner SD, Heald RJ. Transanal Total Mesorectal Excision for Rectal Cancer: Outcomes after 140 Patients. J Am Coll Surg. 2015 Aug;221(2):415-23. doi: 10.1016/j.jamcollsurg.2015.03.046. Epub 2015 Mar 30.
PubMed 26206640de Lacy AM, Rattner DW, Adelsdorfer C, Tasende MM, Fernandez M, Delgado S, Sylla P, Martinez-Palli G. Transanal natural orifice transluminal endoscopic surgery (NOTES) rectal resection: "down-to-up" total mesorectal excision (TME)--short-term outcomes in the first 20 cases. Surg Endosc. 2013 Sep;27(9):3165-72. doi: 10.1007/s00464-013-2872-0. Epub 2013 Mar 22.
PubMed 23519489Velthuis S, Nieuwenhuis DH, Ruijter TE, Cuesta MA, Bonjer HJ, Sietses C. Transanal versus traditional laparoscopic total mesorectal excision for rectal carcinoma. Surg Endosc. 2014 Dec;28(12):3494-9. doi: 10.1007/s00464-014-3636-1. Epub 2014 Jun 28.
PubMed 24972923van der Pas MH, Haglind E, Cuesta MA, Furst A, Lacy AM, Hop WC, Bonjer HJ; COlorectal cancer Laparoscopic or Open Resection II (COLOR II) Study Group. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol. 2013 Mar;14(3):210-8. doi: 10.1016/S1470-2045(13)70016-0. Epub 2013 Feb 6.
PubMed 23395398Lino-Silva LS, Garcia-Gomez MA, Aguilar-Romero JM, Dominguez-Rodriguez JA, Salcedo-Hernandez RA, Loaeza-Belmont R, Ruiz-Garcia EB, Herrera-Gomez A. Mesorectal pathologic assessment in two grades predicts accurately recurrence, positive circumferential margin, and correlates with survival. J Surg Oncol. 2015 Dec;112(8):900-6. doi: 10.1002/jso.24076. Epub 2015 Oct 21.
PubMed 26487289
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathology Assessment of Mesorectal Fascia and Specimen Quality After TME by Laparoscopic, Open, TransAnal and Robotic Approaches (LOTARTME)
- ClinicalTrials.gov ID
- NCT04949672
- Acronym / sponsor ID
- LOTARTME / SGAddolorataH
- Conditions
- Rectal Cancer, Surgery
- Keywords
- TME, TransAnal TME, Mesorectal Fascia, Rectal Cancer Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- San Giovanni Addolorata HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 2 Jul 2021 (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.
TME is the gold standard surgical treatment of rectal cancer. Specimen quality, integrity of mesorectal fascia and lymph nodes harvest are expression of radicality and good surgery. The LOTARTME study is designed to assess which of the open, laparoscopic, robotic and endoscopic transanal approach is superior. Primary outcome is the evaluation of completeness of mesorectal fascia according to Quirke classification. Secondary outcomes are lymph nodes harvest, local recurrences, overall survivals, cancer related survivals. Inclusion criteria: any patient of any age and sex undergoing to intent-to-treat surgery operated by experienced surgeon. Exclusion criteria: patients with rectal cancer undergoing palliative surgery or multivisceral resection; all patients operated by less experienced surgeons. Study period January 1, 2017 - June 30 2021 and patients enrollment: January 1, 2017 - December 31, 2020. Data collection and analysis: data are collected in a prospective database and statical analysis is carried out using AnalystSoft StatPlus for Windows Software.
Detailed description
Developed in 1992 by Heald Total Mesorectal Excision improved the long-term results of rectal cancer treatment with overall survivals increasing up to 80% and local recurrences decreasing down to 4%. Notwithstanding the introduction of laparoscopy and robotic technology and their application in the field of rectal cancer surgery in the last decades, no further improvement of rectal cancer survivals have been reported. Actually, completeness of mesorectal fat and fascia excision seems not to be improved with these new approaches, compared to standard open surgery. It has been proved that local recurrences are strictly related to the quality of TME and are significantly higher when mesorectal fascia is incomplete according to Quirke classification. In 2012 A. Lacy first reported the transanal approach to TME, developed to overcome the high challenges represented by low rectal dissection when difficult anatomy is present (i.e. obese pts, narrow pelvis, bulging tumors) that may impair the quality of surgical specimen and, therefore, increase the incidence of local recurrences and, indirectly, overall cancer related survivals. There is an ongoing clinical trial (COLOR III) that has been designed to assess whether long term results after TaTME are similar, better or worse than those of open or laparoscopic TME. Until then scientists and researchers may evaluate the effectiveness of TaTME compared to other surgical approaches (open, laparoscopic, robotic) assessing the quality of surgical specimens (i.e. completeness of mesorectal excision and integrity of mesorectal fascia according to Quirke classification). Investigators have designed a prospective observational cohort study assessing the quality of specimen and mesorectal fascia in all patients undergoing TME through an open, laparoscopic, robotic and transanal (TaTME) approach between January 2017 and December 2020. All patients have been followed-up with a required minimum follow-up of 6 months. Therefore, the study was terminated on June 2021. Inclusion criteria were: any patient of any age and sex undergoing intent-to-treat surgery operated by experienced surgeon (with ≥ 100 TME performed). Exclusion criteria: patients with rectal cancer undergoing palliative surgery or multivisceral resection, all patients operated by less experienced surgeons (< 100 TME performed).
Objective of the study:
Assessing the quality of the specimen after TME carried out through laparoscopic, open, robotic and endoscopic transanal approach; evaluating whether TaTME might be superior the other approaches in term of radicality of surgery and local recurrencies.
Primary outcome:
Quirke classification of mesorectal fat and fascia completeness. Three grade classification: complete, nearly complete, incomplete.
Secondary outcomes Lymph node harvest Local recurrences Overall survivals Cancer specific survivals Pathology assessment
A fresh specimen or in vacuum packing is sent for macroscopic assessment to the pathologist. The specimen is dealt as follows:
- assessment of mesorectum quality; 2) ink painting of specimen non-peritonealized bare areas 3) the specimen is opened along the anterior aspect from the top and the bottom, leaving the bowel intact at a level just above and just below the tumour; 4) placement of formalin-soaked gauze wicks into the unopened ends of the bowel; 5) the specimen is fixed in 10% buffered formalin for at least 48 hours.
The fixed specimen is dealt as follows:
- 3-5 mm intervals slices through the unopened rectum; 2) slices inspection to note: extent of tumour and the closest distance of tumour to the Circumferential Resection Margin (CRM); positive nodes and the distance of any positive node to the CRM; anterior, posterior or lateral closest distance of tumour to CRM; 3) lymph nodes detection within the fat away from the tumour
Block selection according to the followings:
- tumor blocks showing closest CRM; 2) tumor blocks showing luminal aspect, 3) all lymph nodes; 4) any polyps; 5) proximal and distal resection margins (distal margin includes both mucosa and mesorectum).
The pathologist examined the specimen in a blinded fashion (unaware of the name of the operating surgeon and the technique performed).
Data are collected in a prospective database. Statistical analysis is carried out with AnalystSoft StatPlus for Windows Software. Chi-square test and chi-square test with Yates correction are used considering p-value significative at p<.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Open TME | – | –Total Mesorectal Excision (TME) is the gold standard surgical treatment of rectal cancer. According to the technique first described by Bill Heald, TME entails the resection of the rectum including the whole mesorectal fat and an intact mesorectal fascia. Open TME is accomplished through a midline xifo-umbilical laparotomy and requires a complete mobilization of the left colon and central ligature of inferior mesenteric artery and vein. |
| Laparoscopic TME | – | –Laparoscopic TME mirrors the procedure performed through laparotomy with the same operative steps and performing rectal resection including the excision of the surrounding mesorectal fat and fascia. |
| Robotic TME | – | –Robotic TME mirrors the procedure described by Bill Heald for open surgery but the operation is performed by the master-slave DaVinci System under 3D laparoscopic guidance. The rectal resection is performed including mesorectal fat and fascia. |
| TransAnal TME | – | –TaTME has first described by Antonio Lacy in 2012. This procedure has two steps: abdominal and perineal. The abdominal step is performed through a laparoscopic approach as described for laparoscopic TME but the caudal dissection is stopped right below the level of the peritoneal rectal reflection (Douglas pouch). The perineal step is accomplished transanally inserting a specially designed platform into the anal canal and performing the total mesorectal excision under endoscopic guidance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Stage 1 and 2 rectal cancer patients (preoperative assessment) undergoing surgery without neoadjuvant chemoradiation therapy. Stage 3 and 4 rectal cancer patients undergoing surgery after long-term or short-term chemoradiation therapy.
Key inclusion criteria (2 listed)
- intent to treat procedures
- procedures performed by experienced surgeons (minimum of 100 TME)
Key exclusion criteria (3 listed)
- palliation surgery
- multivisceral resections
- procedures performed by inexperienced surgeons (less of 100 TME)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Completeness of mesorectal fascia and specimen quality (specimen integrity after rectal resection)
Time frame: 4 years
Specimen quality i.e. integrity of mesorectal fascia and clearance of radial margins are an important factor with impact on local recurrency of rectal cancer. the 3-grade Quirke classification is used to assess completeness of mesorectal fascia: complete, nearly complete and incomplete
4 secondary outcomes
Lymph node harvest
Time frame: 4 years
Local recurrence
Time frame: up to 54-month follow-up (range 6-54 months) with a median follow up respectively 54, 39, 38, 39,5 months for the open TME group, for the laparoscopic TME group, for the robotic TME group and for the TaTME group. Overall median FU = 44 months.
Overal survivals
Time frame: Overall median follow-up 44 months (FU range 6-54 months), median follow-up per study group: Open TME 54 months, Laparoscopic TME 39 months, Robotic TME 38 months, TaTME 39,5 months.
Cancer specific survival (CSS)
Time frame: Overall median follow-up 44 months (FU range 6-54 months), median follow-up per study group: Open TME 54 months, Laparoscopic TME 39 months, Robotic TME 38 months, TaTME 39,5 months.
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 2 Jul 2021.
- Background: PubMed 24750995Barnajian M, Pettet D 3rd, Kazi E, Foppa C, Bergamaschi R. Quality of total mesorectal excision and depth of circumferential resection margin in rectal cancer: a matched comparison of the first 20 robotic cases. Colorectal Dis. 2014 Aug;16(8):603-9. doi: 10.1111/codi.12634.
- Results publication: PubMed 17046842Parfitt JR, Driman DK. The total mesorectal excision specimen for rectal cancer: a review of its pathological assessment. J Clin Pathol. 2007 Aug;60(8):849-55. doi: 10.1136/jcp.2006.043802. Epub 2006 Oct 17.
- Results publication: PubMed 25248320Martellucci J, Bergamini C, Bruscino A, Prosperi P, Tonelli P, Todaro A, Valeri A. Laparoscopic total mesorectal excision for extraperitoneal rectal cancer: long-term results. Int J Colorectal Dis. 2014 Dec;29(12):1493-9. doi: 10.1007/s00384-014-2017-5. Epub 2014 Sep 25.
- Results publication: PubMed 17384507Havenga K, Grossmann I, DeRuiter M, Wiggers T. Definition of total mesorectal excision, including the perineal phase: technical considerations. Dig Dis. 2007;25(1):44-50. doi: 10.1159/000099169.
- Results publication: PubMed 26200680Pai A, Marecik SJ, Park JJ, Melich G, Sulo S, Prasad LM. Oncologic and Clinicopathologic Outcomes of Robot-Assisted Total Mesorectal Excision for Rectal Cancer. Dis Colon Rectum. 2015 Jul;58(7):659-67. doi: 10.1097/DCR.0000000000000385.
- Results publication: PubMed 6751457Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery--the clue to pelvic recurrence? Br J Surg. 1982 Oct;69(10):613-6. doi: 10.1002/bjs.1800691019.
- Results publication: PubMed 26206640Lacy AM, Tasende MM, Delgado S, Fernandez-Hevia M, Jimenez M, De Lacy B, Castells A, Bravo R, Wexner SD, Heald RJ. Transanal Total Mesorectal Excision for Rectal Cancer: Outcomes after 140 Patients. J Am Coll Surg. 2015 Aug;221(2):415-23. doi: 10.1016/j.jamcollsurg.2015.03.046. Epub 2015 Mar 30.
- Results publication: PubMed 23519489de Lacy AM, Rattner DW, Adelsdorfer C, Tasende MM, Fernandez M, Delgado S, Sylla P, Martinez-Palli G. Transanal natural orifice transluminal endoscopic surgery (NOTES) rectal resection: "down-to-up" total mesorectal excision (TME)--short-term outcomes in the first 20 cases. Surg Endosc. 2013 Sep;27(9):3165-72. doi: 10.1007/s00464-013-2872-0. Epub 2013 Mar 22.
- Results publication: PubMed 24972923Velthuis S, Nieuwenhuis DH, Ruijter TE, Cuesta MA, Bonjer HJ, Sietses C. Transanal versus traditional laparoscopic total mesorectal excision for rectal carcinoma. Surg Endosc. 2014 Dec;28(12):3494-9. doi: 10.1007/s00464-014-3636-1. Epub 2014 Jun 28.
- Results publication: PubMed 23395398van der Pas MH, Haglind E, Cuesta MA, Furst A, Lacy AM, Hop WC, Bonjer HJ; COlorectal cancer Laparoscopic or Open Resection II (COLOR II) Study Group. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol. 2013 Mar;14(3):210-8. doi: 10.1016/S1470-2045(13)70016-0. Epub 2013 Feb 6.
- Results publication: PubMed 26487289Lino-Silva LS, Garcia-Gomez MA, Aguilar-Romero JM, Dominguez-Rodriguez JA, Salcedo-Hernandez RA, Loaeza-Belmont R, Ruiz-Garcia EB, Herrera-Gomez A. Mesorectal pathologic assessment in two grades predicts accurately recurrence, positive circumferential margin, and correlates with survival. J Surg Oncol. 2015 Dec;112(8):900-6. doi: 10.1002/jso.24076. Epub 2015 Oct 21.
- Individual participant dataSharing planned: No
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Marco Maria Lirici, MD principal investigator
San Giovanni Addolorata Hospital Complex; Saint Camillus International University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Surgery, run by San Giovanni Addolorata Hospital at 1 site in Italy.
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 2 inclusion and 3 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 2 Jul 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 Italy. 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?
Completeness of mesorectal fascia and specimen quality (specimen integrity after rectal resection) (time frame: 4 years). 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 NCT04949672, which also lists 11 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 2 Jul 2021.