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Patient Reported Outcomes Following Cancer of the Rectum

NCT04936581 · University Hospital Gregorio Marañón · Updated 23 Jan 2024

What is being tested
Open Total Mesorectal Excision; Laparoscopic Total Mesorectal Excision; Robotic Total Mesorectal Excision; Transanal Total Mesorectal Excision
For
Sphincter Ani Incontinence; Rectal Cancer
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 100 years. About 200 people. The full rules are on the registry page.
Where
Spain (2 sites)
When
Starts or started 1 Sept 2021, ends Sept 2028. Registered 23 June 2021.
Results
None posted yet.

In the researchers' words

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.…
ClinicalTrials.gov, NCT04936581

Sites

  • University Clinic of NavarreMadrid, Spain
  • University Hospital Gregorio MarañónMadrid, Spain