Robotic vs. TaTME Rectal Surgery (ROTA STUDY)

NCT04200027 | Not Yet Recruiting DMC

• 1 other identifier: svb IAN 151119
• Study Type: observational
• Target: 330
• Locations: 2 countries
• Sites: 2

Brief Summary

Background Recent novel surgical techniques for resection of low rectal cancer have been introduced and these approaches have the potential to overcome anatomical limitations like obesity, narrow male pelvis and bulky and low tumours. Two of these procedures are robotic low anterior resection (RLAR) and transanal total mesorectal excision (TaTME). Both approaches have distinct advantages and limitations however there have been no head to head trial comparing RLAR and TaTME for patients with mid to low rectal cancer undergoing surgery by experienced surgeons. Previous studies looking at the oncological outcomes of either TaTME or robotic TME included many centres where the surgeons were on a learning curve and hence the true oncological outcomes and clinical benefits cannot be measured accurately. The primary objective of this pilot study is to conduct a multicentre prospective trial to investigate clinical outcomes, in particular disease free survival (DFS) in patients undergoing RLAR and TaTME. The additional goal is to investigate other efficacy measures, complications rates, recruitment feasibility and protocol refinement. Method This pilot study will be a prospective, observational, case-matched, two -cohort, multicentre designed to investigate the oncological and clinical outcomes of patients with mid-to-low, non-metastatic rectal cancer undergoing low anterior resection (LAR) using robot-assisted surgery ( RLAR), or transanal total mesorectal excision (TaTME). The inclusion criteria consist of experienced surgeons defined as 60 prior procedures with RLAR or TaTME to meet the enrolment criteria for the RLAR and TaTME arm, respectively. Successful oncological and clinical outcomes are defined as circumferential resection margin (CRM) ≥1 mm with minimal postoperative morbidity (absence of Clavien-Dindo grade III-IV complications within 30 days after surgery). Local and distal recurrence rates with DFS over 3 years will be measured as primary outcome. Secondary and exploratory endpoints will include length of hospital stay, intraoperative time, intraoperative blood loss, harvested lymph nodes, distal resection margin, incompleteness of mesorectum, CRM involvement, unplanned conversion rates, 30-days postoperative complications and overall recurrence rate. The Quality of life assessment questionnaires will be performed preoperatively, 6 months and 12 months after reversal of ileostomy. Propensity score matching will be used to minimize bias from the nonrandomized treatment assignment. The RLAR and TaTME cohorts will be matched by propensity scores accounting for factors significantly associated with either undergoing robotic surgery or TaTME occurrence on logistic regression analysis. Ethics and Dissemination The medical ethical committees of all the participating countries will be involved in approving the study protocol. Results of the primary and secondary end points will be submitted for publication in peer-reviewed journals.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• oncological outcomes RLAR vs TaTMe

  The primary aim of the study is to compare the 3 year disease free survival between RLAR and TaTME in the hands of an experienced surgeon

  3 year disease free survival

Study Arms (2)

Robotic total mesorectal Excision

robotic assissted total mesorectal excision

Procedure: total mesorectal excision

Transanal total mesorectal excision

Transanally assissted total mesorectal excision

Procedure: total mesorectal excision

Interventions

total mesorectal excision PROCEDURE

Total Mesorectal Excision Total Mesorectal Excision is currently the standard technique for surgical treatment of RC. It was first described in 1982 by Bill Heald, and relies on the excision of the whole mesorectum within an intact mesorectal fascia, with the contained lymphatic system along with the tumour bearing bowel segment Total mesorectal excision

Robotic total mesorectal Excision; Transanal total mesorectal excision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The primary study end point, DFS is defined as the time following successful surgery to the first date of local, regional/distant relapse or death due to colorectal cancer (patients with secondary malignancy will be censored). Overall survival is defined as the time following successful surgery to death.

You may qualify if:

• Participant is willing and able to give informed consent for participation in the trial.
• Male or Female, aged 18 years or above.
• Undergoing TME surgery for rectal cancer after MDT discussion.
• Participant has no contra-indication to pelvic radiotherapy at the time of enrolment.
• In the Investigator's opinion, is able and willing to comply with all trial requirements.
• Tumour distance from anal verge - 12 cm or less
• Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.

You may not qualify if:

• Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
• Participant with life expectancy of less than 6 months.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Sponsors & Collaborators

• Odense University Hospital: lead
• Portsmouth Hospitals NHS Trust: collaborator

Study Sites (2)

Issam al-Najami

Svendborg, Southern Denmark, 5700, Denmark

Location

Jim Khan

Portsmouth, United Kingdom

Location

Related Publications (22)

• Wiseman M. The second World Cancer Research Fund/American Institute for Cancer Research expert report. Food, nutrition, physical activity, and the prevention of cancer: a global perspective. Proc Nutr Soc. 2008 Aug;67(3):253-6. doi: 10.1017/S002966510800712X. Epub 2008 May 1.

  PMID: 18452640 BACKGROUND

• Heald 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.

  PMID: 6751457 BACKGROUND

• Heald RJ, Ryall RD. Recurrence and survival after total mesorectal excision for rectal cancer. Lancet. 1986 Jun 28;1(8496):1479-82. doi: 10.1016/s0140-6736(86)91510-2.

  PMID: 2425199 BACKGROUND

• van 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.

  PMID: 23395398 BACKGROUND

• Bonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MH, de Lange-de Klerk ES, Lacy AM, Bemelman WA, Andersson J, Angenete E, Rosenberg J, Fuerst A, Haglind E; COLOR II Study Group. A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med. 2015 Apr 2;372(14):1324-32. doi: 10.1056/NEJMoa1414882.

  PMID: 25830422 BACKGROUND

• Jeong SY, Park JW, Nam BH, Kim S, Kang SB, Lim SB, Choi HS, Kim DW, Chang HJ, Kim DY, Jung KH, Kim TY, Kang GH, Chie EK, Kim SY, Sohn DK, Kim DH, Kim JS, Lee HS, Kim JH, Oh JH. Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): survival outcomes of an open-label, non-inferiority, randomised controlled trial. Lancet Oncol. 2014 Jun;15(7):767-74. doi: 10.1016/S1470-2045(14)70205-0. Epub 2014 May 15.

  PMID: 24837215 BACKGROUND

• Kang SB, Park JW, Jeong SY, Nam BH, Choi HS, Kim DW, Lim SB, Lee TG, Kim DY, Kim JS, Chang HJ, Lee HS, Kim SY, Jung KH, Hong YS, Kim JH, Sohn DK, Kim DH, Oh JH. Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): short-term outcomes of an open-label randomised controlled trial. Lancet Oncol. 2010 Jul;11(7):637-45. doi: 10.1016/S1470-2045(10)70131-5. Epub 2010 Jun 16.

  PMID: 20610322 BACKGROUND

• Hompes R, Guy R, Jones O, Lindsey I, Mortensen N, Cunningham C. Transanal total mesorectal excision with a side-to-end stapled anastomosis - a video vignette. Colorectal Dis. 2014 Jul;16(7):567. doi: 10.1111/codi.12660. No abstract available.

  PMID: 24801986 BACKGROUND

• Sun Y, Xu H, Li Z, Han J, Song W, Wang J, Xu Z. Robotic versus laparoscopic low anterior resection for rectal cancer: a meta-analysis. World J Surg Oncol. 2016 Mar 1;14:61. doi: 10.1186/s12957-016-0816-6.

  PMID: 26928124 BACKGROUND

• Lee SH, Lim S, Kim JH, Lee KY. Robotic versus conventional laparoscopic surgery for rectal cancer: systematic review and meta-analysis. Ann Surg Treat Res. 2015 Oct;89(4):190-201. doi: 10.4174/astr.2015.89.4.190. Epub 2015 Sep 25.

  PMID: 26448918 BACKGROUND

• Trastulli S, Farinella E, Cirocchi R, Cavaliere D, Avenia N, Sciannameo F, Gulla N, Noya G, Boselli C. Robotic resection compared with laparoscopic rectal resection for cancer: systematic review and meta-analysis of short-term outcome. Colorectal Dis. 2012 Apr;14(4):e134-56. doi: 10.1111/j.1463-1318.2011.02907.x.

  PMID: 22151033 BACKGROUND

• Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, Quirke P, West N, Rautio T, Thomassen N, Tilney H, Gudgeon M, Bianchi PP, Edlin R, Hulme C, Brown J. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial. JAMA. 2017 Oct 24;318(16):1569-1580. doi: 10.1001/jama.2017.7219.

  PMID: 29067426 BACKGROUND

• Yang Y, Wang F, Zhang P, Shi C, Zou Y, Qin H, Ma Y. Robot-assisted versus conventional laparoscopic surgery for colorectal disease, focusing on rectal cancer: a meta-analysis. Ann Surg Oncol. 2012 Nov;19(12):3727-36. doi: 10.1245/s10434-012-2429-9. Epub 2012 Jul 3.

  PMID: 22752371 BACKGROUND

• 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: 27735827 BACKGROUND

• Perez D, Melling N, Biebl M, Reeh M, Baukloh JK, Miro J, Polonski A, Izbicki JR, Knoll B, Pratschke J, Aigner F. Robotic low anterior resection versus transanal total mesorectal excision in rectal cancer: A comparison of 115 cases. Eur J Surg Oncol. 2018 Feb;44(2):237-242. doi: 10.1016/j.ejso.2017.11.011. Epub 2017 Nov 26.

  PMID: 29249592 BACKGROUND

• Kwak JM, Kim SH. Current status of robotic colorectal surgery. J Robot Surg. 2011 Mar;5(1):65-72. doi: 10.1007/s11701-010-0217-8. Epub 2010 Oct 2.

  PMID: 27637262 BACKGROUND

• Lee L, de Lacy B, Gomez Ruiz M, Liberman AS, Albert MR, Monson JRT, Lacy A, Kim SH, Atallah SB. A Multicenter Matched Comparison of Transanal and Robotic Total Mesorectal Excision for Mid and Low-rectal Adenocarcinoma. Ann Surg. 2019 Dec;270(6):1110-1116. doi: 10.1097/SLA.0000000000002862.

  PMID: 29916871 BACKGROUND

• Penna M, Hompes R, Arnold S, Wynn G, Austin R, Warusavitarne J, Moran B, Hanna GB, Mortensen NJ, Tekkis PP; International TaTME Registry Collaborative. Incidence and Risk Factors for Anastomotic Failure in 1594 Patients Treated by Transanal Total Mesorectal Excision: Results From the International TaTME Registry. Ann Surg. 2019 Apr;269(4):700-711. doi: 10.1097/SLA.0000000000002653.

  PMID: 29315090 BACKGROUND

• Larsen SG, Pfeffer F, Korner H. Author response to: Comments on: Norwegian moratorium on transanal total mesorectal excision. Br J Surg. 2019 Dec;106(13):1855. doi: 10.1002/bjs.11374. No abstract available.

  PMID: 31747073 BACKGROUND

• Knight CD, Griffen FD. An improved technique for low anterior resection of the rectum using the EEA stapler. Surgery. 1980 Nov;88(5):710-4.

  PMID: 7434211 BACKGROUND

• Cohen Z, Myers E, Langer B, Taylor B, Railton RH, Jamieson C. Double stapling technique for low anterior resection. Dis Colon Rectum. 1983 Apr;26(4):231-5. doi: 10.1007/BF02562484.

  PMID: 6839891 BACKGROUND

• Jootun R, Cuk P, Ellebaek M, Andersen PV, Salomon S, Baatrup G, Al-Najami I, Khan J. Robotic vs. TaTME Rectal Surgery (ROTA STUDY) Matched Cohort Trial for Mid to Low Rectal Cancer Surgery Evaluation Trial in the Hands of an Experienced Surgeon. Int J Surg Protoc. 2022 Feb 18;26(1):7-13. doi: 10.29337/ijsp.163. eCollection 2022.

  PMID: 35280494 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Issam al najami, phd

  The Department of clinical research, University of Southern Denmark, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Issam Al-Najami, phd

CONTACT

51909297; al_najami@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator. phd. associate professor

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: November 15, 2021
• Primary Completion: November 1, 2023
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: november 2019-november 2022

Locations

GB (1); DK (1)