Rectal Surgery Evaluation Trial (RESET)

NCT03574493 | Completed

• 1 other identifier: PROICM 2018-03 ORE
• Study Type: observational
• Target: 1,098
• Locations: 1 country
• Sites: 1

Brief Summary

Total mesorectal excision (TME) is the standard of care for rectal cancer, which can be combined with low anterior resection (LAR) in patients with mid-to-low rectal cancer. The narrow pelvic space and difficulties in obtaining adequate exposure make surgeries technically challenging. Four techniques are used to perform the surgery: open laparotomy, laparoscopy, robot-assisted surgery, and transanal surgery. Comparative data for these techniques is required to provide clinical data on the surgical management of rectal cancers by surgery.

Conditions

Rectal Cancer

Keywords

laparotomy; laparoscopy; low anterior resection; rectal cancer; robot assisted surgery; total mesorectal excision; transanal surgery

Outcome Measures

Primary Outcomes (1)

• Efficacy of surgical method (success determined by composite of Oncologic, morbidity and functional outcomes)

  CRM, TME grade III, The absence of clavien dindo grade III-IV complications within 30 days post op

  up to 4 years

Study Arms (4)

Open laparotomy

A surgical procedure involving a large incision through the abdominal wall to gain access into the abdominal cavity.

Procedure: TME with LAR

Laparoscopic surgery

A minimally-invasive technique in which operations are performed via small incisions (usually 0.5-1.5 cm) at a location distant to the site of interest.

Procedure: TME with LAR

Robot-assisted surgery using the da Vinci® Surgical System

A minimally-invasive approach that allows good precision, flexibility, and control.

Procedure: TME with LAR

Transanal surgery through the anus

Where the protectomy is performed down to up until the Douglas pouch

Procedure: TME with LAR

Interventions

TME with LAR PROCEDURE

Several surgical techniques are used to perform TME. Dissection using open laparotomy and minimally-invasive laparoscopic or robot-assisted abdominal approaches is performed in a 'top-down' manner, where the instruments are inserted transabdominally and the procedure progresses from splenic flexure/sigmoid colon mobilization to rectal resection. A transanal approach may also be used, a 'bottom-up' procedure where instruments are inserted through the anus to perform rectal resection and TME

Laparoscopic surgery; Open laparotomy; Robot-assisted surgery using the da Vinci® Surgical System; Transanal surgery through the anus

Eligibility Criteria

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

Study Population

high- risk patients with mid-to-low rectal cancer

You may qualify if:

• Age ≥ 18 years old
• Rectal adenocarcinoma from middle and lower third (less than 10 cm from the anal verge) with a sphincter saving procedure
• High risk operative patients (two of these factors as assessed on MRI):
• Obese patient with a BMI \> 30 (male or female)
• Narrow pelvis: inter-tuberous distance \< 10 cm
• Large tumoral volume with suspicion of close predictive margin (CRM ≤ 1 mm) at diagnosis
• Expected coloanal or ultra-low colorectal anastomosis
• Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of ≤2)

You may not qualify if:

• Patient with a comorbid illness or condition that would preclude the use of surgery.
• Patients with T4b tumors which impose a pelvectomy
• Patient requires an abdominal perineal resection (APR)
• Patients with concurrent or previous invasive pelvic malignant tumors (cervical, uterine, or rectal; excluding the prostate) within 5 years before study enrollment
• Patient undergoing emergency procedures
• Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections)
• Metastatic disease
• Pregnant or suspected pregnancy
• Patients unwilling to comply with all follow-up study requirements
• Patient included in another study which impact on the surgical technique or its choice.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead
• Intuitive Surgical: collaborator

Study Sites (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Related Publications (22)

• 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

• MacFarlane JK, Ryall RD, Heald RJ. Mesorectal excision for rectal cancer. Lancet. 1993 Feb 20;341(8843):457-60. doi: 10.1016/0140-6736(93)90207-w.

  PMID: 8094488 BACKGROUND

• Buchs NC, Nicholson GA, Ris F, Mortensen NJ, Hompes R. Transanal total mesorectal excision: A valid option for rectal cancer? World J Gastroenterol. 2015 Nov 7;21(41):11700-8. doi: 10.3748/wjg.v21.i41.11700.

  PMID: 26556997 BACKGROUND

• Sun Z, Kim J, Adam MA, Nussbaum DP, Speicher PJ, Mantyh CR, Migaly J. Minimally Invasive Versus Open Low Anterior Resection: Equivalent Survival in a National Analysis of 14,033 Patients With Rectal Cancer. Ann Surg. 2016 Jun;263(6):1152-8. doi: 10.1097/SLA.0000000000001388.

  PMID: 26501702 BACKGROUND

• Vennix S, Pelzers L, Bouvy N, Beets GL, Pierie JP, Wiggers T, Breukink S. Laparoscopic versus open total mesorectal excision for rectal cancer. Cochrane Database Syst Rev. 2014 Apr 15;2014(4):CD005200. doi: 10.1002/14651858.CD005200.pub3.

  PMID: 24737031 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

• 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

• 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

• 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

• 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

• 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

• 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

• Stevenson AR, Solomon MJ, Lumley JW, Hewett P, Clouston AD, Gebski VJ, Davies L, Wilson K, Hague W, Simes J; ALaCaRT Investigators. Effect of Laparoscopic-Assisted Resection vs Open Resection on Pathological Outcomes in Rectal Cancer: The ALaCaRT Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1356-63. doi: 10.1001/jama.2015.12009.

  PMID: 26441180 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Baik SH, Kwon HY, Kim JS, Hur H, Sohn SK, Cho CH, Kim H. Robotic versus laparoscopic low anterior resection of rectal cancer: short-term outcome of a prospective comparative study. Ann Surg Oncol. 2009 Jun;16(6):1480-7. doi: 10.1245/s10434-009-0435-3. Epub 2009 Mar 17.

  PMID: 19290486 BACKGROUND

• Fleshman J, Branda M, Sargent DJ, Boller AM, George V, Abbas M, Peters WR Jr, Maun D, Chang G, Herline A, Fichera A, Mutch M, Wexner S, Whiteford M, Marks J, Birnbaum E, Margolin D, Larson D, Marcello P, Posner M, Read T, Monson J, Wren SM, Pisters PW, Nelson H. Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051 Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1346-55. doi: 10.1001/jama.2015.10529.

  PMID: 26441179 BACKGROUND

• Chessin DB, Enker W, Cohen AM, Paty PB, Weiser MR, Saltz L, Minsky BD, Wong WD, Guillem JG. Complications after preoperative combined modality therapy and radical resection of locally advanced rectal cancer: a 14-year experience from a specialty service. J Am Coll Surg. 2005 Jun;200(6):876-82; discussion 882-4. doi: 10.1016/j.jamcollsurg.2005.02.027.

  PMID: 15922198 BACKGROUND

• Sebag-Montefiore D, Stephens RJ, Steele R, Monson J, Grieve R, Khanna S, Quirke P, Couture J, de Metz C, Myint AS, Bessell E, Griffiths G, Thompson LC, Parmar M. Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial. Lancet. 2009 Mar 7;373(9666):811-20. doi: 10.1016/S0140-6736(09)60484-0.

  PMID: 19269519 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.

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  PMID: 9802183 BACKGROUND

• Rouanet P, Guerrieri M, Lemercier P, Balik E, Cotte E, Spinelli A, Gomez-Ruiz M, Wolthuis A, Bertani E, Dubois A; on behalf the RESET study group. A Prospective European Trial Comparing Laparotomy, Laparoscopy, Robotic-Assisted, and Transanal Total Mesorectal Excision Procedures in High-Risk Patients with Rectal Cancer: The RESET Trial. Ann Surg. 2024 Sep 12. doi: 10.1097/SLA.0000000000006534. Online ahead of print.

  PMID: 39263755 DERIVED

• Sgarbura O, Gourgou S, Tosi D, Bakrin N, Bouazza N, Delaine S, De Forges H, Pocard M, Quenet F. MESOTIP: Phase II multicenter randomized trial evaluating the association of PIPAC and systemic chemotherapy vs. systemic chemotherapy alone as 1st-line treatment of malignant peritoneal mesothelioma. Pleura Peritoneum. 2019 Jun 27;4(2):20190010. doi: 10.1515/pp-2019-0010. eCollection 2019 Jun 1.

  PMID: 31417958 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Receptor-Like Protein Tyrosine Phosphatases, Class 2

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

Intervention Hierarchy (Ancestors)

Receptor-Like Protein Tyrosine Phosphatases; Protein Tyrosine Phosphatases; Phosphoric Monoester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Philippe ROUANET, MD

  ICM Co. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 2, 2018
• Study Start: October 16, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)