Clinical trial NCT03107650: Preoperative Prediction Model of Pathological Outcomes (Mesorectum Quality and Positive Circumferential Resection Margin) in Patients With Mid-low Rectal Cancer
Official title: Preoperative Prediction Model of Pathological Outcomes (Mesorectum Quality and Positive Circumferential Resection Margin) in Patients With Mid-low Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected of mid-low rectal cancer

Brief summary: Elaboration of a preoperative prediction model of the quality of the mesorectum and the involvement of the circumferential margin in patients with mid-low rectal cancer who undergo laparoscopic anterior rectal resection.

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.


Eligibility criteria: Inclusion Criteria:

* Patients directed to laparoscopic anterior rectal resection through a transabdominal or a transanal approach.
* 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:

* TNM classification: T1 or T4.
* Complicated rectal cancer or emergency surgery.
* Previous major colorectal surgery

Primary outcomes:
measure: Evaluation of the quality of mesorectum in the rectal specimen according to international consensus (goog quality, moderate quality and poor quality)
timeFrame: 30 days
measure: Evaluation of the circumferential margin status in the rectal specimen according international consensus (positive margin if tumor ≤ 1mm from circumferential margin)
timeFrame: 30 days
Secondary outcomes:
measure: Recurrence
timeFrame: 2 years
measure: Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Girona
country: Spain
facility: University Hospital Dr. Josep Trueta of Girona
Study officials:
References:
citation: 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.
citation: 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.