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Trial record 29 of 1444 for:    Prediction | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03107650
Recruitment Status : Not yet recruiting
First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Pere Planellas Giné, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

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.


Condition or disease Intervention/treatment
Rectal Cancer Procedure: Transanal total mesorectal excision of rectal cancer

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preoperative Prediction Model of Pathological Outcomes (Mesorectum Quality and Positive Circumferential Resection Margin) in Patients With Mid-low Rectal Cancer
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : February 2023

Group/Cohort Intervention/treatment
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
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



Primary Outcome Measures :
  1. Evaluation of the quality of mesorectum in the rectal specimen according to international consensus (goog quality, moderate quality and poor quality) [ Time Frame: 30 days ]

    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).


  2. Evaluation of the circumferential margin status in the rectal specimen according international consensus (positive margin if tumor ≤ 1mm from circumferential margin) [ Time Frame: 30 days ]
    Evaluation of the circumferential margin status (positive or negative) in the rectal specimen according international consensus (positive margin if tumor ≤ 1mm from circumferential margin)


Secondary Outcome Measures :
  1. Recurrence [ Time Frame: 2 years ]
    Rate of tumor recurrence

  2. Survival [ Time Frame: 2 years ]
    Rate of survival



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients affected of mid-low rectal cancer
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

Responsible Party: Pere Planellas Giné, MD PhD, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
ClinicalTrials.gov Identifier: NCT03107650     History of Changes
Other Study ID Numbers: 0485762
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases