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Feasibility Bowel Dysfunction Program After Low Anterior Resection

Primary Purpose

Rectal Cancer, Low Anterior Resection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stoma reversal
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rectal Cancer focused on measuring Bowel Dysfunction, Low Anterior Resection, Rectal Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgery for Stoma Reversal

Arm Description

All study participants will receive stoma reversal, complete baseline questionnaire, pelvic floor training and follow up questionnaires

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
October 30, 2017
Last Updated
February 1, 2021
Sponsor
Fox Chase Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04733794
Brief Title
Feasibility Bowel Dysfunction Program After Low Anterior Resection
Official Title
Feasibility of Implementing a Comprehensive, Patient-Centered Approach to Bowel Dysfunction After Low Anterior Resection for Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 19, 2016 (Actual)
Primary Completion Date
September 6, 2017 (Actual)
Study Completion Date
December 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Low Anterior Resection
Keywords
Bowel Dysfunction, Low Anterior Resection, Rectal Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery for Stoma Reversal
Arm Type
Experimental
Arm Description
All study participants will receive stoma reversal, complete baseline questionnaire, pelvic floor training and follow up questionnaires
Intervention Type
Procedure
Intervention Name(s)
Stoma reversal
Intervention Description
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
Primary Outcome Measure Information:
Title
Bowel dysfunction
Description
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
Time Frame
12 months
Title
Urinary function
Description
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
Time Frame
12 months
Title
Sexual function
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility Bowel Dysfunction Program After Low Anterior Resection

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