Actively Recruiting

Age: 18Years - 100Years
All Genders
NCT04936581

Patient Reported Outcomes Following Cancer of the Rectum

Led by University Hospital Gregorio Marañón · Updated on 2024-01-23

200

Participants Needed

2

Research Sites

365 weeks

Total Duration

On this page

Sponsors

U

University Hospital Gregorio Marañón

Lead Sponsor

U

University of Navarrra Hospital (Clinica Universitaria)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Patient Reported Outcomes Following Cancer of the Rectum

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years old
  • Provided informed consent
  • Diagnosed with rectal cancer located below the peritoneal reflection confirmed by preoperative MRI
  • Undergoing open, laparoscopic, robotic, or transanal Total Mesorectal Excision (taTME)
  • Patients with or without derivative stoma
  • Patients with or without neoadjuvant treatment
Not Eligible

You will not qualify if you...

  • 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 including uterus, prostate, vagina, or bladder
  • Rectal resection due to benign condition
  • Rectal resection due to 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

University Clinic of Navarre

Madrid, Spain

Actively Recruiting

2

University Hospital Gregorio Marañón

Madrid, Spain

Actively Recruiting

Loading map...

Research Team

P

Patricia Tejedor

CONTACT

P

Patricia Tejedor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here