Patient Reported Outcomes Following Cancer of the Rectum

NCT ID: NCT04936581

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2028-09-30

Brief 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.

Detailed Description

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.

Conditions

Sphincter Ani Incontinence; Rectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Open Total Mesorectal Excision

Patients undergoing open low anterior resection

Open Total Mesorectal Excision

Intervention Type: PROCEDURE

Open approach for Total Mesorectal Excision

Laparoscopic Total Mesorectal Excision

Patients undergoing laparoscopic low anterior resection

Laparoscopic Total Mesorectal Excision

Intervention Type: PROCEDURE

Laparoscopic approach for Total Mesorectal Excision

Robotic Total Mesorectal Excision

Patients undergoing robotic low anterior resection

Robotic Total Mesorectal Excision

Intervention Type: PROCEDURE

Robotic approach for Total Mesorectal Excision

Transanal Total Mesorectal Excision

Patients undergoing transanal Total Mesorectal Excision (taTME)

Transanal Total Mesorectal Excision

Intervention Type: PROCEDURE

Transanal approach for Total Mesorectal Excision

Interventions

Open Total Mesorectal Excision

Open approach for Total Mesorectal Excision

Intervention Type: PROCEDURE

Laparoscopic Total Mesorectal Excision

Laparoscopic approach for Total Mesorectal Excision

Intervention Type: PROCEDURE

Robotic Total Mesorectal Excision

Robotic approach for Total Mesorectal Excision

Intervention Type: PROCEDURE

Transanal Total Mesorectal Excision

Transanal approach for Total Mesorectal Excision

Intervention Type: PROCEDURE

Eligibility Criteria

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
• Patients 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
• 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 primary neoplasm)
• Rectal resection following a 'watch & wait' program
• Emergency surgery
• Previous derivative colostomy
• Inflammatory bowel disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Navarrra Hospital (Clinica Universitaria)

OTHER

Sponsor Role: collaborator

Hospital de Leon

OTHER_GOV

Sponsor Role: collaborator

Hospital del Rio Hortega

OTHER

Sponsor Role: collaborator

University Hospital Gregorio Marañón

OTHER

Sponsor Role: lead

Responsible Party

Patricia Tejedor

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Clinic of Navarre

Madrid, , Spain

Site Status: RECRUITING

University Hospital Gregorio Marañón

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Patricia Tejedor

Role: CONTACT

patricia.tejedor@hotmail.com

+34 91 586 7007

Patricia Tejedor

Role: CONTACT

+34 91 586 7007

Facility Contacts

Carlos Pastor

Role: primary

Patricia Tejedor

Role: primary

References

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Other Identifiers

205/15

Identifier Type: -

Identifier Source: org_study_id

NCT06290960

Identifier Type: -

Identifier Source: nct_alias