Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00579579 |
| Other study ID # |
06-151 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 28, 2006 |
| Est. completion date |
February 15, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Memorial Sloan Kettering Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to find out what happens to patients after they have surgery for
rectal cancer. After being treated for rectal cancer, patients tell us that their bowel,
bladder and sexual function have changed. We are trying to understand how these changes
affect your quality of life. The research that we have now does not explain these changes or
problems very well. The patients will be asked questions about bowel function, bladder
function, sexual function, and quality of life so we can understand these changes better.
This will help us take better care of our patients in the future, before and after their
treatment for rectal cancer.
Description:
Rectal cancer is the second most common cancer in North America. Therapy has rapidly improved
over the last 20 years, and the surgical technique of total mesorectal excision, as well as
advances in radiation and chemotherapy, have resulted in improved survival and decreased
local recurrence. As a result, survivorship issues become increasingly important for patients
with rectal cancer.
Patients uniformly demonstrate a strong desire to avoid a permanent stoma and show strong
preferences for sphincter preserving surgery (SPS). With the introduction of the circular
stapler, SPS is technically possible in a higher proportion of patients. Additionally, even
tumors at the anorectal ring are considered amenable to SPS in select patients with ultra-low
rectal cancers.
At present, long-term outcomes after rectal cancer surgery are poorly understood. Bowel,
bladder and sexual function appear to be negatively affected by multi-modality therapy.
However, function has been poorly studied, and it is difficult to translate the data into
clinically meaningful information for patients. Clinically, bowel, bladder and sexual
dysfunction seem to affect quality of life (QOL), although this has never been well studied.
It is important to quantify the extent of impairment so that it can be used to educate
patients preoperatively. However, translating these data to clinicians and patients remains
challenging, and efforts to convey the data in a meaningful manner preoperatively constitute
an important element in managing patient expectations. By understanding patients' baseline
needs, expectations and satisfaction at the time of the preoperative consent, we can begin to
develop novel preoperative strategies for educating patients about postoperative function and
quality of life in a meaningful manner, so that they may better adapt after surgery. We
ultimately plan to use data from this study to develop and subsequently evaluate the role of
an educational tool outlining functional outcomes after rectal cancer surgery.
