NCT03413904

Brief Summary

This study is designed as a prospective, multi-center, randomized, open-labelled, parallel group, non-inferiority trial. The aim of this study is to evaluate the TaTME technique compared with conventional laparoscopic rectal surgery, focusing on, anastomotic dehiscence, conversion rate to open surgery, hospital stay and long-term functional outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 27, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

January 15, 2018

Last Update Submit

August 7, 2018

Conditions

Rectal Cancer

Keywords

taTME

Outcome Measures

Primary Outcomes (2)

  • Anastomotic leakage

    Evaluate the effectiveness of the T-TME versus L-LAR in term of clinically evident anastomotic leak rate.

    30 days

  • Conversion to open

    Evaluate the effectiveness of the T-TME versus L-LAR in term of conversion to open surgery

    intraoperative

Secondary Outcomes (6)

  • Pathology

    30 days

  • QoL

    12 months

  • Functional results

    12 months

  • Functional results 2

    12 months

  • postoperative complications

    30 days

  • +1 more secondary outcomes

Study Arms (2)

transanal TME

EXPERIMENTAL

Study procedure will consist in 2-team (combined) LAR with transanal TME using laparoscopic abdominal assistance.Transanal TME is performed either at the same time or following the above steps. 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 using a Pfannenstiel incision followed by colorectal anastomosis, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Procedure: transanal TME

laparoscopic TME

ACTIVE COMPARATOR

Procedure will consist in 1 team performing laparoscopic TME. Following stapled closure of the rectum below the tumor, and complete mobilization of the rectosigmoid, the specimen is extracted using a Pfannenstiel incision . A stapled (knight-Griffen) colorectal anastomosis or coloanal anastomosis will be created and a temporary diverting stoma will be fashioned which is standard of care following surgery for this type of cancer.

Procedure: laparoscopic TME

Interventions

transanal TMEPROCEDURE

transanal approach to TME in rectal cancer

transanal TME
laparoscopic TMEPROCEDURE

laparoscopic approach to TME in rectal cancer

laparoscopic TME

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically proven solitary mid and low rectal cancer
  • proven by rigid rectoscopy, pelvic MRI and digital rectal examination (DRE)
  • amenable to curative sphincter-preserving surgery
  • no evidence of distant metastases (T3-4a,N0 or T1-4a,N1-2)
  • if evaluated after neoadiuvant therapy, no evidence of threaten of the mesorectal fascia (MRF) after therapy

You may not qualify if:

  • no indication to perform sphincter preservation surgery (Tumors invading into the internal anal sphincter muscle based on pelvic MRI)
  • T4b tumor invading adjacent organs
  • recurrent cancer
  • concurrent or previous diagnosis of invasive cancer within 5 years
  • prior history of colorectal resection
  • tumors with in growth more than 1/3 of anal sphincter complex or levator ani.
  • presence of fecal incontinence at baseline according to Wexner's classification
  • emergent surgery with intestinal obstruction or perforation
  • absolute contraindications to general anaesthesia or prolonged pneumoperitoneum, such as severe cardiovascular or respiratory disease (ASA class \> III)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele

Milan, 20060, Italy

RECRUITING

Related Publications (20)

  • Kang J, Choi GS, Oh JH, Kim NK, Park JS, Kim MJ, Lee KY, Baik SH. Multicenter Analysis of Long-Term Oncologic Impact of Anastomotic Leakage After Laparoscopic Total Mesorectal Excision: The Korean Laparoscopic Colorectal Surgery Study Group. Medicine (Baltimore). 2015 Jul;94(29):e1202. doi: 10.1097/MD.0000000000001202.

    PMID: 26200636BACKGROUND

  • Leroy J, Jamali F, Forbes L, Smith M, Rubino F, Mutter D, Marescaux J. Laparoscopic total mesorectal excision (TME) for rectal cancer surgery: long-term outcomes. Surg Endosc. 2004 Feb;18(2):281-9. doi: 10.1007/s00464-002-8877-8. Epub 2003 Dec 29.

    PMID: 14691716BACKGROUND

  • Morino M, Parini U, Giraudo G, Salval M, Brachet Contul R, Garrone C. Laparoscopic total mesorectal excision: a consecutive series of 100 patients. Ann Surg. 2003 Mar;237(3):335-42. doi: 10.1097/01.SLA.0000055270.48242.D2.

    PMID: 12616116BACKGROUND

  • Goldberg S, Klas JV. Total mesorectal excision in the treatment of rectal cancer: a view from the USA. Semin Surg Oncol. 1998 Sep;15(2):87-90. doi: 10.1002/(sici)1098-2388(199809)15:23.0.co;2-1.

    PMID: 9730414BACKGROUND

  • Kapiteijn E, Kranenbarg EK, Steup WH, Taat CW, Rutten HJ, Wiggers T, van Krieken JH, Hermans J, Leer JW, van de Velde CJ. Total mesorectal excision (TME) with or without preoperative radiotherapy in the treatment of primary rectal cancer. Prospective randomised trial with standard operative and histopathological techniques. Dutch ColoRectal Cancer Group. Eur J Surg. 1999 May;165(5):410-20. doi: 10.1080/110241599750006613.

    PMID: 10391155BACKGROUND

  • Marks JH, Myers EA, Zeger EL, Denittis AS, Gummadi M, Marks GJ. Long-term outcomes by a transanal approach to total mesorectal excision for rectal cancer. Surg Endosc. 2017 Dec;31(12):5248-5257. doi: 10.1007/s00464-017-5597-7. Epub 2017 Jun 22.

    PMID: 28643051BACKGROUND

  • Arroyave MC, DeLacy FB, Lacy AM. Transanal total mesorectal excision (TaTME) for rectal cancer: Step by step description of the surgical technique for a two-teams approach. Eur J Surg Oncol. 2017 Feb;43(2):502-505. doi: 10.1016/j.ejso.2016.10.024. Epub 2016 Nov 20.

    PMID: 27914773BACKGROUND

  • Penna M, Hompes R, Arnold S, Wynn G, Austin R, Warusavitarne J, Moran B, Hanna GB, Mortensen NJ, Tekkis PP; TaTME Registry Collaborative. Transanal Total Mesorectal Excision: International Registry Results of the First 720 Cases. Ann Surg. 2017 Jul;266(1):111-117. doi: 10.1097/SLA.0000000000001948.

    PMID: 27735827BACKGROUND

  • Atallah S, Albert M, Monson JR. Critical concepts and important anatomic landmarks encountered during transanal total mesorectal excision (taTME): toward the mastery of a new operation for rectal cancer surgery. Tech Coloproctol. 2016 Jul;20(7):483-94. doi: 10.1007/s10151-016-1475-x. Epub 2016 May 17.

    PMID: 27189442BACKGROUND

  • Deijen CL, Velthuis S, Tsai A, Mavroveli S, de Lange-de Klerk ES, Sietses C, Tuynman JB, Lacy AM, Hanna GB, Bonjer HJ. COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer. Surg Endosc. 2016 Aug;30(8):3210-5. doi: 10.1007/s00464-015-4615-x. Epub 2015 Nov 4.

    PMID: 26537907BACKGROUND

  • Lacy AM, Adelsdorfer C, Delgado S, Sylla P, Rattner DW. Minilaparoscopy-assisted transrectal low anterior resection (LAR): a preliminary study. Surg Endosc. 2013 Jan;27(1):339-46. doi: 10.1007/s00464-012-2443-9. Epub 2012 Jul 18.

    PMID: 22806513BACKGROUND

  • Lacy 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.

    PMID: 26206640BACKGROUND

  • Fernandez-Hevia M, Delgado S, Castells A, Tasende M, Momblan D, Diaz del Gobbo G, DeLacy B, Balust J, Lacy AM. Transanal total mesorectal excision in rectal cancer: short-term outcomes in comparison with laparoscopic surgery. Ann Surg. 2015 Feb;261(2):221-7. doi: 10.1097/SLA.0000000000000865.

    PMID: 25185463BACKGROUND

  • Lelong B, de Chaisemartin C, Meillat H, Cournier S, Boher JM, Genre D, Karoui M, Tuech JJ, Delpero JR; French Research Group of Rectal Cancer Surgery (GRECCAR). A multicentre randomised controlled trial to evaluate the efficacy, morbidity and functional outcome of endoscopic transanal proctectomy versus laparoscopic proctectomy for low-lying rectal cancer (ETAP-GRECCAR 11 TRIAL): rationale and design. BMC Cancer. 2017 Apr 11;17(1):253. doi: 10.1186/s12885-017-3200-1.

    PMID: 28399840BACKGROUND

  • Hua L, Wang C, Yao K, Zhang J, Chen J, Ma W. Is the incidence of postoperative anastomotic leakage different between laparoscopic and open total mesorectal excision in patients with rectal cancer? A meta-analysis based on randomized controlled trials and controlled clinical trials. J Cancer Res Ther. 2014 Dec;10 Suppl:272-5. doi: 10.4103/0973-1482.151491.

    PMID: 25693934BACKGROUND

  • Staudacher C, Vignali A, Saverio DP, Elena O, Andrea T. Laparoscopic vs. open total mesorectal excision in unselected patients with rectal cancer: impact on early outcome. Dis Colon Rectum. 2007 Sep;50(9):1324-31. doi: 10.1007/s10350-007-0289-3.

    PMID: 17665258BACKGROUND

  • Veenhof AA, Engel AF, Craanen ME, Meijer S, de Lange-de Klerk ES, van der Peet DL, Meijerink WJ, Cuesta MA. Laparoscopic versus open total mesorectal excision: a comparative study on short-term outcomes. A single-institution experience regarding anterior resections and abdominoperineal resections. Dig Surg. 2007;24(5):367-74. doi: 10.1159/000107778. Epub 2007 Aug 20.

    PMID: 17785982BACKGROUND

  • Intention to treat analysis and per protocol analysis: complementary information. Prescrire Int. 2012 Dec;21(133):304-6.

    PMID: 23373104BACKGROUND

  • Shah PB. Intention-to-treat and per-protocol analysis. CMAJ. 2011 Apr 5;183(6):696; author reply 696. doi: 10.1503/cmaj.111-2033. No abstract available.

    PMID: 21464181BACKGROUND

  • Quirke P, West N. Quality of surgery: has the time come for colon cancer? Lancet Oncol. 2015 Feb;16(2):121-2. doi: 10.1016/S1470-2045(14)71223-9. Epub 2014 Dec 31. No abstract available.

    PMID: 25555422BACKGROUND

Related Links

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Andrea Vignali

    IRCCS San Raffaele

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Aleotti

CONTACT

0039 3208562194aleotti.francesca@hsr.it

Andrea Vignali

CONTACT

vignali.andrea@hsr.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 15, 2018

First Posted

January 29, 2018

Study Start

March 27, 2018

Primary Completion

February 29, 2020

Study Completion

February 28, 2023

Last Updated

August 9, 2018

Record last verified: 2018-08

Locations

IT(1)