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Functional Outcomes and Quality of Life in Patients Undergoing Surgery for Rectal Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

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Trial Information

Functional Outcomes and Quality of Life in Patients Undergoing Surgery for Rectal Cancer


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.


Inclusion Criteria:



- Stage I-III rectal adenocarcinoma based on preoperative testing

- Surgery (Sphincter preserving - transanal (TAE),transanal endoscopic microsurgery
(TEM), low anterior resection (LAR), coloanal resection (CAA), OR Permanent stoma -
abdominal perineal resection (APR)) planned at MSKCC

- Age > or = to 18

- Speak English

Exclusion Criteria:

- Stage IV disease at time of pre-operative consult

- History of other malignancies (besides squamous cell or basal cell cancer of skin)
less than five years ago

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To prospectively evaluate bowel, sexual and bladder function in patients who undergo resection for stage I-III rectal cancer.

Outcome Time Frame:

Two sets of surveys before surgery. After surgery, the participant will be asked to fill out some or all of a series of surveys at 6, 12, and 24 months.

Safety Issue:

No

Principal Investigator

Larissa Temple, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

06-151

NCT ID:

NCT00579579

Start Date:

November 2006

Completion Date:

December 2013

Related Keywords:

  • Rectal Cancer
  • Bowel function
  • Bladder function
  • Sexual function
  • Quality of life
  • Rectal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021