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Patient Reported Outcomes Following Cancer of the Rectum (PROCaRe)

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ClinicalTrials.gov Identifier: NCT04936581
Recruitment Status : Not yet recruiting
First Posted : June 23, 2021
Last Update Posted : June 30, 2021
Sponsor:
Collaborators:
University of Navarrra Hospital (Clinica Universitaria)
Hospital de Leon
Hospital del Río Hortega
Information provided by (Responsible Party):
Patricia Tejedor, University Hospital Gregorio Marañón

Brief Summary:

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.


Condition or disease Intervention/treatment
Sphincter Ani Incontinence Rectal Cancer Procedure: Open Total Mesorectal Excision Procedure: Laparoscopic Total Mesorectal Excision Procedure: Robotic Total Mesorectal Excision Procedure: Transanal Total Mesorectal Excision

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Reported Outcomes Following Cancer of the Rectum
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023

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




Primary Outcome Measures :
  1. Low anterior resection syndrome (LARS) score [ Time Frame: 2022 ]
    LARS score from 0-42 where 0 means better outcomes

  2. Vaizey score [ Time Frame: 2022 ]
    Incontinence score from 0-28 where 0 means better outcomes


Secondary Outcome Measures :
  1. QLQ C30 [ Time Frame: 2022 ]
    Quality of Life questionnaire

  2. QLQ CR29 [ Time Frame: 2022 ]
    Quality of life questionnaire, colorectal cancer related

  3. Male sexual function [ Time Frame: 2022 ]
    IIEF questionnaire

  4. Female sexual function [ Time Frame: 2022 ]
    FSFI questionnaires

  5. Urinary function [ Time Frame: 2022 ]
    IPSS questionnaire

  6. Postoperative complications [ Time Frame: 2022 ]
    Dindo-Clavien classification



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants that meet the criteria will be identified in each centre
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04936581


Contacts
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Contact: Patricia Tejedor +34 91 586 7007 patricia.tejedor@hotmail.com
Contact: Patricia Tejedor +34 91 586 7007

Locations
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Spain
University Hospital Gregorio Marañón
Madrid, Spain
Sponsors and Collaborators
University Hospital Gregorio Marañón
University of Navarrra Hospital (Clinica Universitaria)
Hospital de Leon
Hospital del Río Hortega
Publications of Results:

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Responsible Party: Patricia Tejedor, Principal Investigator, University Hospital Gregorio Marañón
ClinicalTrials.gov Identifier: NCT04936581    
Other Study ID Numbers: 205/15
First Posted: June 23, 2021    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patricia Tejedor, University Hospital Gregorio Marañón:
rectal cancer
taTME
laparoscopic TME
robotic TME
open TME
low anterior resection syndrome
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases