Preoperative Prediction Model of Pathological Outcomes (Mesorectum Quality and Positive Circumferential Resection Margin) in Patients With Mid-low Rectal Cancer
NCT ID: NCT03107650
Last Updated: 2021-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
323 participants
OBSERVATIONAL
2018-01-01
2020-07-31
Brief Summary
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In a second phase the investigators will study the utility of the prediction model in classifying patients with high risk of suboptimal quality of mesorectum and/or positive circumferential margin. Patients with high preoperative risk will undergo a transanal total mesorectal excision and patients with low risk a laparoscopic transabdominal mesorectal excision. The investigators finally will compare pathological outcomes ( quality of mesorectum and circumferential margin), survival and recurrence between the two groups.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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High risk patients
Patients with high risk of suboptimal mesorectum quality and/or positive circumferential margin after the application of the preoperative prediction model developed
Transanal total mesorectal excision of rectal cancer
To perform a total mesorectal excision through a transanal approach
Low risk patients
Patients with low risk of suboptimal mesorectum quality and/or positive circumferential margin after the application of the preoperative prediction model developed
No interventions assigned to this group
Interventions
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Transanal total mesorectal excision of rectal cancer
To perform a total mesorectal excision through a transanal approach
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Histology of adenocarcinoma or adenoma
* With or without neoadjuvant chemoradiotherapy
* TNM classification: T2 or T3, any N stage or M stage
* Intention of resection R0
Exclusion Criteria
* Complicated rectal cancer or emergency surgery.
* Previous major colorectal surgery
18 Years
90 Years
ALL
No
Sponsors
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Pere Planellas Giné
OTHER
Responsible Party
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Pere Planellas Giné
MD PhD
Locations
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University Hospital Dr. Josep Trueta of Girona
Girona, , Spain
Countries
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References
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Planellas P, Marinello F, Elorza G, Golda T, Farres R, Espin-Basany E, Enriquez-Navascues JM, Kreisler E, Cornejo L, Codina-Cazador A. Extended Versus Standard Complete Mesocolon Excision in Sigmoid Colon Cancer: A Multicenter Randomized Controlled Trial. Ann Surg. 2022 Feb 1;275(2):271-280. doi: 10.1097/SLA.0000000000005161.
Planellas P, Salvador H, Cornejo L, Buxo M, Farres R, Molina X, Maroto A, Ortega N, Rodriguez-Hermosa JI, Codina-Cazador A. Risk factors for suboptimal laparoscopic surgery in rectal cancer patients. Langenbecks Arch Surg. 2021 Mar;406(2):309-318. doi: 10.1007/s00423-020-02029-0. Epub 2020 Nov 27.
Other Identifiers
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0485762
Identifier Type: -
Identifier Source: org_study_id
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