Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 2 locations
1
University Clinic of Navarre
Madrid, Spain
Actively Recruiting
2
University Hospital Gregorio Marañón
Madrid, Spain
Actively Recruiting
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
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