Clinical trial · Observational
Pathology Assessment of Mesorectal Fascia After TME by Laparoscopic, Open, TransAnal and Robotic Approaches (LOTARTME)
Pathology Assessment of Mesorectal Fascia and Specimen Quality After TME by Laparoscopic, Open, TransAnal and Robotic Approaches (LOTARTME)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Open TME
- description
- 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.
- label
- Laparoscopic TME
- description
- 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.
- label
- Robotic TME
- description
- 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.
- label
- TransAnal TME
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * intent to treat procedures * procedures performed by experienced surgeons (minimum of 100 TME) Exclusion Criteria: * palliation surgery * multivisceral resections * procedures performed by inexperienced surgeons (less of 100 TME)
References
Publications (11)
- BACKGROUNDBarnajian 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
- RESULTParfitt 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
- RESULTMartellucci 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
- RESULTHavenga 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
- RESULTPai 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
- RESULTHeald 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
- RESULTLacy 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.