Preoperative Prediction Model of Pathological Outcomes (Mesorectum Quality and Positive Circumferential Resection Margin) in Patients With Mid-low Rectal Cancer

NCT03107650 | Completed DMC

• 1 other identifier: 0485762
• Study Type: observational
• Target: 323
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (2)

• Evaluation of the quality of mesorectum in the rectal specimen according to international consensus (goog quality, moderate quality and poor quality)

  Evaluation of the quality of mesorectum as optimal or suboptimal (international consensus defines three grades of resection: Group 1: including mesorectal resection, good quality Group 2: intramesorectal resection: moderate quality Group 3: resection in the muscularis propria, poor quality). Investigators will group patients into two groups: optimal mesorectum (group 1) and suboptimal mesorectum (group 2-3).

  30 days

• Evaluation of the circumferential margin status in the rectal specimen according international consensus (positive margin if tumor ≤ 1mm from circumferential margin)

  Evaluation of the circumferential margin status (positive or negative) in the rectal specimen according international consensus (positive margin if tumor ≤ 1mm from circumferential margin)

  30 days

Secondary Outcomes (2)

• Recurrence

  2 years

• Survival

  2 years

Study Arms (2)

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

Procedure: Transanal total mesorectal excision of rectal cancer

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

Interventions

Transanal total mesorectal excision of rectal cancer PROCEDURE

To perform a total mesorectal excision through a transanal approach

High risk patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients affected of mid-low rectal cancer

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pere Planellas Giné: lead

Study Sites (1)

University Hospital Dr. Josep Trueta of Girona

Girona, 17007, Spain

Location

Related Publications (2)

• 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.

  PMID: 34417367 DERIVED

• 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.

  PMID: 33244719 DERIVED

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 11, 2017
• Study Start: January 1, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)