Patient Reported Outcomes Following Cancer of the Rectum (PROCaRe)

March 13, 2024 updated by: Patricia Tejedor, Hospital Central de la Defensa Gómez Ulla

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The rectum is located in a narrow space, limited by the bone and surrounded tissues, in a very complex and narrow pelvic space. It necessarily implies greater difficulty in achieving tumour-free margins3, and preserving sexual, urinary and fecal continence functions. Depending on the height of the tumor, the difficulty of preserving the anal sphincter arises, being able to perform a low anterior resection (LAR), an ultra-low anterior resection (RAUB) or an intersphincteric ultra-low anterior resection (ISR). Finally, if it is not impossible to preserve the sphincters or to make an anastomosis, an abdominoperineal resection (APR) is needed, being the gold standard in this particular situation.

In order to perform a correct surgery, all the previous alternatives must follow the principle of Total Mesorectal Excision (TME) described by Heald in 1982. There is no consensus nowadays regarding the ideal approach for this procedure, and it can be performed using open or minimally invasive surgery, including laparoscopy, transanal approach (taTME), and robotic surgery.

Laparoscopic surgery has shown great advantages over open surgery, such as less postoperative pain, shorter hospital stay and early recovery. However, this approach has some technical difficulties, especially when it comes to tumours located at the mid-low rectum, in male and obese patients, which leads to a higher conversion rate for this subgroup of patients. This is why this laparoscopic procedure is considered highly demanding, and the 'European Society of Coloproctology' published in a cross-sectional study only 20% of laparoscopic surgery in such cases.

Robotic surgery then emerged with the idea of overcoming these technical difficulties. It has shown better results in terms of conversion to open surgery, despite an increase in operative time and higher economic costs. Some studies showed an improvement in erectile function after robotic surgery compared to laparoscopy, as well as a trend towards better functional results. However, its adoption worldwide is slow due to a lack of availability in most of centers.

Due to this controversy, a new approach that combines laparoscopic abdominal and transanal dissection has emerged in the last decade, the taTME. To date, several retrospective and prospective studies have been published, which show similar short and long-term results between techniques. However, after ensuring oncological results, surgeons must also focus on sphincter and bowel function, and patients' quality of life after surgery.

Anal sphincter sparing surgery is currently the most commonly performed in rectal cancer patients. 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, after rectal resection and reconstruction. Of these patients, 25-50% will have severe changes in quality of life. This wide spectrum of symptoms has been called 'Low Anterior Resection Syndrome' (LARS). Another collateral damage caused during surgery affects to sexual and urinary function, due to hypogastric nerves damage. There is an important lack of multicenter prospective studies providing evidence, and showing pateints' functional results and quality of life after all these techniques available for the management of rectal cancer.

RATIONALE For these reasons, it is essential to have a validated instrument that allows us to assess sphincter function and the different aspects of quality of life in patients undergoing surgery for rectal cancer, since increased survival in this pathology has led to greater importance in the evaluation functional outcome and quality of life. Moreover, there are some recent studies showing a direct relation between these factors.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

• Population:

  • Patient selection: Participants that meet the criteria will be identified in each centre
  • Patient information sheet (Appendix 1) will be given in clinic and informed consent (Appendix 2) will be obtain before including the patient in the study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Open surgery
Patients undergoing open surgery
Procedure: Open surgery
Anterior resection and primary anastomosis with/without derivative stoma, by open approach
Laparoscopic surgery
Patients undergoing laparoscopic surgery
Procedure: Laparoscopic surgery
Anterior resection and primary anastomosis with/without derivative stoma, by laparoscopic approach
Robotic surgery
Patients undergoing robotic surgery
Procedure: Robotic surgery
Anterior resection and primary anastomosis with/without derivative stoma, by robotic approach
taTME
Patients undergoing taTME surgery
Procedure: taTME
Anterior resection and primary anastomosis with/without derivative stoma, by transanal approach (taTME)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low anterior resection syndrome score
Time Frame: baseline - 36 months
LARS score, min 0 - max 41 (higher means more severe)
baseline - 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (CRC29 and CR30)
Time Frame: baseline - 36 months
Questionnaires CRC29 and CR30
baseline - 36 months
Female Sexual Function Index
Time Frame: baseline - 36 months
min 0 - max 36 (higher means more severe)
baseline - 36 months
International Prostate Syndrome Score
Time Frame: baseline - 36 months
min 0 max 35 (higher means more severe)
baseline - 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Central de la Defensa Gómez Ulla

Collaborators

Clinica Universidad de Navarra, Universidad de Navarra

Investigators

  • Principal Investigator: Patricia Tejedor, M.D., Ph.D., University Hospital Gregorio Marañón

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 21, 2022

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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