Rectal Cancer Clinical Trial
— PROCaReOfficial title:
Patient Reported Outcomes Following Cancer of the Rectum
Verified date | March 2024 |
Source | Hospital Central de la Defensa Gómez Ulla |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The surgical management of rectal cancer includes a Total Mesorectal Exicison (TME). 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 pereoperative MRI, 3) undergoing Open, laparoscopic, robotic or Transanal Total Mesorectal Excision (taTME) approaches, 4) with/withou 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 pimary neoplasm), 10) rectal resection following a 'watch & wait' program, 11) emergency surgery, 12) previous derivative colostomy 13) inflammatory bowel disease. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 45 subjects are necessary in first group and 45 in the second to recognize as statistically significant a difference greater than or equal to 2 units. The common standard deviation is assumed to be 3. It has been anticipated a drop-out rate of 20% Primary outcomes are LARS and Vaizey score. Secondary outcomes included are QLQ C30 and CR29, sexual function questionnaire (female/male), urinary function questionnaire and postoperative complications (Clavien-Dindo classification) Data will be collected in an online secure and protected repository (Castor edc). The planned study period is 2 years (September 2021 - September 2023). It is essential to have a validated instrument that allows us to assess sphincter function and the different aspects of quality of life in operated patients, since increased survival in this pathology has led to greater importance in the evaluation functional outcome and quality of life; Furthermore, there are recent studies that speak of the direct relationship between these factors.
Status | Enrolling by invitation |
Enrollment | 1000 |
Est. completion date | December 2027 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 - Patinets with/without derivative stoma - Patients with/without neoadjuvant treatment Exclusion Criteria: - Upper rectal cancer, located above the peritoneal reflection - Previous radical prostatectomy - Previous pelvic radiotherapy due to another tumour - Rectal resection without primary anastomosis - Intraoperative findings of peritoneal carcinomatosis - Stage IV disease - Multivisceral or en-bloc resection, which includes uterus, prostate, vagina or bladder - Rectal resection due to a benign condition - Rectal resection due to a recurrence of rectal cancer (previous anterior resection or another pimary neoplasm) - Rectal resection following a 'watch & wait' program - Emergency surgery - Previous derivative colostomy - Inflammatory bowel disease |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General Universitario Gregorio Marañon | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital Central de la Defensa Gómez Ulla | Clinica Universidad de Navarra, Universidad de Navarra |
Spain,
Tejedor P, Arredondo J, Pellino G, Pata F, Pastor C; PROCaRe study group. Patient Reported Outcomes following Cancer of the Rectum (PROCaRe): protocol of a prospective multicentre international study. Tech Coloproctol. 2023 Dec;27(12):1345-1350. doi: 10.1007/s10151-023-02865-4. Epub 2023 Sep 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Low anterior resection syndrome score | LARS score, min 0 - max 41 (higher means more severe) | baseline - 36 months | |
Secondary | Quality of Life (CRC29 and CR30) | Questionnaires CRC29 and CR30 | baseline - 36 months | |
Secondary | Female Sexual Function Index | min 0 - max 36 (higher means more severe) | baseline - 36 months | |
Secondary | International Prostate Syndrome Score | min 0 max 35 (higher means more severe) | baseline - 36 months |
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