Tracking Bowel, Sexual and Urinary Changes After Rectal Cancer Surgery
Studies bowel, sexual and urinary changes in adults after surgery for rectal cancer.
Plain-language title generated from the registry record
Registry title: Patient Reported Outcomes Following Cancer of the Rectum
Key facts
- Where
- Madrid, SpainSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with rectal cancer below the peritoneal reflection who are having a total mesorectal excision (TME) operation. It studies bowel, urinary and sexual function and quality of life afterwards.
- Age
- 18 to 100 years
- Sex
- All sexes can join.
- Disease stage
- Rectal cancer below the peritoneal reflection, shown on a scan (MRI) before surgery. Stage IV disease cannot join.
- Earlier treatment
- Patients can join with or without a stoma and with or without treatment before surgery (neoadjuvant). Previous pelvic radiotherapy, radical prostatectomy or a colostomy are not allowed.
Main reasons for not taking part
- Cancer in the upper rectum, above the peritoneal reflection
- Stage IV disease or cancer spread inside the belly (peritoneal carcinomatosis)
- Previous pelvic radiotherapy or previous radical prostatectomy
- Emergency surgery, or surgery for a benign condition or for a returned (recurrent) cancer
- Inflammatory bowel disease
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT04936581, who can take part
Where in Spain
- University Clinic of NavarreMadrid, SpainContact: Carlos PastorTaking people
- University Hospital Gregorio MarañónMadrid, SpainContact: Patricia TejedorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Hospital Gregorio Marañón
- Trial code
- NCT04936581
- Record updated
- 23 January 2024
- Original description
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.Read full original descriptionShow less
Patient Reported Outcomes Following Cancer of the Rectum
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.
Inclusion: 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: Previous radical prostatectomy; Previous pelvic radiotherapy; Rectal resection without primary anastomosis; Multivisceral or en-bloc resection, which includes uterus, prostate, vagina or bladder; 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; Upper rectal cancer, located above the peritoneal reflection; Stage IV disease; Rectal resection due to a benign condition; Inflammatory bowel disease; Intraoperative findings of peritoneal carcinomatosis.