Patient Reported Outcomes Following Cancer of the Rectum

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
University Clinic of Navarre
RECRUITING
Madrid
University Hospital Gregorio Marañón
RECRUITING
Madrid
Contact Information
Primary
Patricia Tejedor
patricia.tejedor@hotmail.com
+34 91 586 7007
Backup
Patricia Tejedor
+34 91 586 7007
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2028-09
Participants
Target number of participants: 200
Treatments
Open Total Mesorectal Excision
Patients undergoing open low anterior resection
Laparoscopic Total Mesorectal Excision
Patients undergoing laparoscopic low anterior resection
Robotic Total Mesorectal Excision
Patients undergoing robotic low anterior resection
Transanal Total Mesorectal Excision
Patients undergoing transanal Total Mesorectal Excision (taTME)
Sponsors
Collaborators: Hospital de Leon, Hospital del Rio Hortega, University of Navarrra Hospital (Clinica Universitaria)
Leads: University Hospital Gregorio Marañón

This content was sourced from clinicaltrials.gov