Pathology Assessment of Mesorectal Fascia After TME by Laparoscopic, Open, TransAnal and Robotic Approaches (LOTARTME)

NCT04949672 | Completed

• 1 other identifier: SGAddolorataH
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Rectal Cancer; Surgery

Keywords

TME; TransAnal TME; Mesorectal Fascia; Rectal Cancer Surgery

Outcome Measures

Primary Outcomes (1)

• 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

  4 years

Secondary Outcomes (4)

• Lymph node harvest

  4 years

• Local recurrence

  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

  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)

  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.

Study Arms (4)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• intent to treat procedures
• procedures performed by experienced surgeons (minimum of 100 TME)

You may not qualify if:

• palliation surgery
• multivisceral resections
• procedures performed by inexperienced surgeons (less of 100 TME)

Sponsors & Collaborators

• San Giovanni Addolorata Hospital: lead

Study Sites (1)

San Giovanni Addolorata Hospital Complex

Roma, RM, 00182, Italy

Location

Related Publications (11)

• 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.

  PMID: 24750995 BACKGROUND

• Parfitt 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.

  PMID: 17046842 RESULT

• Martellucci 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.

  PMID: 25248320 RESULT

• Havenga 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.

  PMID: 17384507 RESULT

• Pai 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.

  PMID: 26200680 RESULT

• 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 RESULT

• 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: 26206640 RESULT

• de 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.

  PMID: 23519489 RESULT

• Velthuis 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.

  PMID: 24972923 RESULT

• 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 RESULT

• Lino-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.

  PMID: 26487289 RESULT

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

• Marco Maria Lirici, MD

  San Giovanni Addolorata Hospital Complex; Saint Camillus International University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: July 2, 2021
• Study Start: January 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: June 29, 2021
• Last Updated: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)