Feasibility Bowel Dysfunction Program After Low Anterior Resection

Rectal Cancer Clinical Trial

Official title:

Feasibility of Implementing a Comprehensive, Patient-Centered Approach to Bowel Dysfunction After Low Anterior Resection for Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04733794
• Other study ID #: 15-8016
• Status: Completed
• Phase: N/A
• Start date: February 19, 2016
• Est. completion date: December 18, 2018

Study information

• Verified date: February 2021
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will facilitate a better understanding of the overall experience of our rectal cancer survivors after Low Anterior Resection for rectal cancer. Studies have demonstrated that the development of bowel and genitourinary dysfunction after this procedure is very distressing to patients and can have a significant impact on overall quality of life. By providing interventions that can be performed at home, investigator may alleviate these symptoms in hopes of improving the experience of patients undergoing Low Anterior Resection. By acknowledging these potentially debilitating symptoms in a systematic way, the investigator hopes to reinforce the importance of symptom management in the survivorship phase after treatment has been completed and ultimately facilitate an individual's return to routine activities.

Description:

Subjects will be recruited from patients presenting to the surgical oncology clinic at Fox Chase Cancer Center. These patients will have already undergone Low Anterior Resection with a diverting stoma (colostomy or ileostomy) and will be planning on undergoing reversal of their stoma in the near future. Subjects will be recruited over a period of 1 year. Such clinic patients' medical records will be reviewed to determine whether they are possible candidates for inclusion in the study. They will be identified based on their diagnosis of either Stage II or III rectal cancer as stated in prior clinic notes, pathology reports, or radiologic image reports. Participants must have previously undergone Low Anterior Resection with a diverting stoma and the surgical plan must be for them to undergo ostomy reversal. They will be approached during a clinic visit by either a co-investigator or a member of the surgery team (fellow or surgeon) or a research coordinator delegate and asked to participate in the research study. They will be given a document for informed consent that will describe the study and potential risks and benefits to the patient. The investigators plan to enroll 10 patients at Fox Chase Cancer Center. Subjects will receive no monetary compensation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 18, 2018
• Est. primary completion date: September 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Stage II or III rectal cancer, a history of having an LAR with diverting stoma, and a plan to undergo stoma reversal within the next 6 months

Exclusion Criteria:

• Patients enrolled who develop an anastomotic leak at the time of stoma reversal that would necessitate another temporary or permanent stoma, they will be considered unevaluable and will be excluded from the analysis

Related Conditions & MeSH terms

• Intestinal Diseases
• Low Anterior Resection
• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Stoma reversal
Patients will receive a comprehensive intervention to addresses bowel, sexual, and urinary dysfunction. Patients meeting appropriate inclusion criteria will be approached at a clinic visit with their surgeon. If they agree to participate, they will complete an initial baseline questionnaire. Questionnaires will be distributed on iPads during their clinic visit

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel dysfunction	Symptoms will be assessed at scheduled visits with patient's provider by means of the follow up questionnaire containing 11 questions scored on a scale from 0 to 4 with a minimum score of 1 and a maximum score of 44	12 months
Primary	Urinary function	Symptoms will be assessed at scheduled visits with patient's provider by means of the follow up questionnaire containing 11 questions scored on a scale from 0 to 4 with a minimum score of 1 and a maximum score of 44	12 months
Primary	Sexual function	Symptoms will be assessed at scheduled visits with patient's provider by means of the follow up questionnaire containing 8-10 questions (8 for women and 10 for men) scored on a scale from 0 to 4 with a minimum score of 0 and maximum score of 40	12 months