Patient Reported Outcomes Following Cancer of the Rectum (PROCaRe)

January 22, 2024 updated by: Patricia Tejedor, University Hospital Gregorio Marañón

The surgical management of rectal cancer includes a Total Mesorectal Excison (TME); depending on the height of the tumor, the problem of preservation of the anal sphincter arises, being able to perform a low anterior resection, an ultra-low anterior resection (RAUB) or an intersphincteric dissection. In some cases invading the sphincters or the puborectalis muscle, an abdominoperineal resection needs to be performed, being the gold standard in this particular situation so far.

TME can be performed by open, laparoscopic, robotic or transanal approaches, as long as the oncological principles for the resection are achieved. Unfortunately, up to 90% of these patients will present a change in bowel habit, ranging from an increased frequency of bowel movements to the degree of fecal incontinence or evacuation dysfunction. Of these patients, 25-50% will have a severe alteration in the quality of life. This wide spectrum of symptoms has been called "low anterior resection syndrome" (LARS). Other collateral damage is the change in sexual and urinary function, due to hypogastric plexus injury. There is a significant lack of multicenter prospective studies that provide evidence, and that reveal the functional results and quality of life of these techniques available to date for the management of rectal cancer.

The study is set up as a prospective multicentre observational study. Inclusion criteria are: 1) patients over 18 years old, 2) diagnosed with rectal cancer located below the peritoneal reflection, defined by preoperative MRI, 3) undergoing Open, laparoscopic, robotic or Transanal Total Mesorectal Excision (taTME) approaches, 4) with/without derivative stoma and 5) with/without neoadjuvant treatment. Exclusion criteria are: 1) Upper rectal cancer, located above the peritoneal reflection, 2) previous radical prostatectomy, 3) previous pelvic radiotherapy, 4) rectal resection without primary anastomosis, 5) intraoperative findings of peritoneal carcinomatosis, 6) stage IV disease, 7) multivisceral or en-bloc resection, which includes uterus, prostate, vagina or bladder, 8) rectal resection due to a benign condition, 9) rectal resection due to a recurrence of rectal cancer (previous anterior resection or another primary neoplasm), 10) rectal resection following a 'watch & wait' program, 11) emergency surgery, 12) previous derivative colostomy 13) inflammatory bowel disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 45 subjects are necessary in first group and 45 in the second to recognize as statistically significant a difference greater than or equal to 2 units. The common standard deviation is assumed to be 3. It has been anticipated a drop-out rate of 20% Primary outcomes are LARS and Vaizey score. Secondary outcomes included are QLQ C30 and CR29, sexual function questionnaire (female/male), urinary function questionnaire and postoperative complications (Clavien-Dindo classification) Data will be collected in an online secure and protected repository (Castor edc). The planned study period is 2 years (September 2021 - September 2023).

It is essential to have a validated instrument that allows us to assess sphincter function and the different aspects of quality of life in operated patients, since increased survival in this pathology has led to greater importance in the evaluation functional outcome and quality of life; Furthermore, there are recent studies that speak of the direct relationship between these factors.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Patricia Tejedor
  • Phone Number: +34 91 586 7007

Study Locations

  • Spain
      • Madrid, Spain
        • Recruiting
        • University Clinic of Navarre
        • Contact:
          • Carlos Pastor
      • Madrid, Spain
        • Recruiting
        • University Hospital Gregorio Marañón
        • Contact:
          • Patricia Tejedor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants that meet the criteria will be identified in each centre

Description

Inclusion Criteria:

  • Patients over 18 years old
  • Informed consent
  • Diagnosed with rectal cancer located below the peritoneal reflection, defined by preoperative MRI
  • Open, laparoscopic, robotic or Transanal Total Mesorectal Excision (taTME) approaches
  • Patients with/without derivative stoma
  • Patients with/without neoadjuvant treatment

Exclusion Criteria:

  • Upper rectal cancer, located above the peritoneal reflection
  • Previous radical prostatectomy
  • Previous pelvic radiotherapy
  • Rectal resection without primary anastomosis
  • Intraoperative findings of peritoneal carcinomatosis
  • Stage IV disease
  • Multivisceral or en-bloc resection, which includes uterus, prostate, vagina or bladder
  • Rectal resection due to a benign condition
  • Rectal resection due to a recurrence of rectal cancer (previous anterior resection or another primary neoplasm)
  • Rectal resection following a 'watch & wait' program
  • Emergency surgery
  • Previous derivative colostomy
  • Inflammatory bowel disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Open Total Mesorectal Excision
Patients undergoing open low anterior resection
Procedure: Open Total Mesorectal Excision
Open approach for Total Mesorectal Excision
Laparoscopic Total Mesorectal Excision
Patients undergoing laparoscopic low anterior resection
Procedure: Laparoscopic Total Mesorectal Excision
Laparoscopic approach for Total Mesorectal Excision
Robotic Total Mesorectal Excision
Patients undergoing robotic low anterior resection
Procedure: Robotic Total Mesorectal Excision
Robotic approach for Total Mesorectal Excision
Transanal Total Mesorectal Excision
Patients undergoing transanal Total Mesorectal Excision (taTME)
Procedure: Transanal Total Mesorectal Excision
Transanal approach for Total Mesorectal Excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low anterior resection syndrome (LARS) score
Time Frame: 2022
LARS score from 0-42 where 0 means better outcomes
2022
Vaizey score
Time Frame: 2022
Incontinence score from 0-28 where 0 means better outcomes
2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QLQ C30
Time Frame: 2022
Quality of Life questionnaire
2022
QLQ CR29
Time Frame: 2022
Quality of life questionnaire, colorectal cancer related
2022
Male sexual function
Time Frame: 2022
IIEF questionnaire
2022
Female sexual function
Time Frame: 2022
FSFI questionnaires
2022
Urinary function
Time Frame: 2022
IPSS questionnaire
2022
Postoperative complications
Time Frame: 2022
Dindo-Clavien classification
2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Gregorio Marañón

Collaborators

Hospital del Río Hortega
Hospital de Leon
University of Navarrra Hospital (Clinica Universitaria)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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