Bowel; Functional SyndromeNCT05339763
Long Term Bowel Function Following Rectal Cancer Surgery
A study testing chemoradiotherapy in people with Bowel; Functional Syndrome and Rectal Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
In this longitudinal study, 171 patients were evaluated and compared based on the radiation therapy they received. Bowel function was assessed longitudinally with Memorial Sloan Kettering Cancer Center and Wexner scores every 6 months after restoration of bowel continuity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bowel; Functional Syndrome, Rectal Cancer
- What is being tested?
- chemoradiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Aug 2019to 25 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes,
- Aged between 18 and 75 years,
- Patients with mid and upper rectal cancer (6-15) cm from the anal verge(AV) with or without preoperative chemo radiotherapy.
- Patients who underwent low anterior resection(LAR).
- Patients who were followed up with at least two outpatient visits for bowel function assessment.
Who cannot join
- Patients with recurrent rectal tumors,
- Surgically unfit patients,
- Patients with tumors infiltrating the puborectalis muscle or external sphincter.
- Patients with preoperative fecal incontinence.
- Patients who were followed up only once in the outpatient clinic.
- Patients with lower rectal cancer less than 6cm from AV,
- Patients who underwent abdominoperineal resection(APR) or intersphincteric resection(ISR).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Bowel Functional Outcomes Following Anal Sphincter Preserving Surgery for Rectal Cancer: A Single Center Longitudinal Study.
- In this longitudinal study, 171 patients were evaluated and compared based on the radiation therapy they received.
- Bowel function was assessed longitudinally with Memorial Sloan Kettering Cancer Center and Wexner scores every 6 months after restoration of bowel continuity. Patients with at least two follow-up visits were included.
Read the detailed description
Background Despite advances in the neoadjuvant chemoradiation therapy and anal sphincter-preserving surgeries for rectal cancer, bowel dysfunction is still unavoidable which negatively affect the patients' quality of life. In this longitudinal study, The aim of this study was to investigate the changes in bowel function with follow up time and the effect of the neoadjuvant chemo radiotherapy on bowel function following low anterior resection for rectal cancer.
Materials and methods In this study, 171 patients with rectal cancer who underwent low anterior resection between 2012 and 2018 were included. Bowel function was assessed longitudinally with Memorial Sloan Kettering Cancer Center and Wexner scores every 6 months after restoration of bowel continuity. Patients with at least two follow-up visits were included.
- Conditions
- Bowel; Functional Syndrome, Rectal Cancer
- Being tested
- chemoradiotherapy
- Keywords
- Rectal cancer, Sphincter preserving surgery, Neoadjuvant therapy, ow anterior resection syndrome
- Medical subject headings
- Irritable Bowel Syndrome, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemoradiotherapyRadiation
Also called neoadjuvant chemoradiotherapy
exposure of patients with rectal cancer to radiotherapy and assessment of their bowel function after surgery
| Study group | Role | What they receive |
|---|---|---|
| radiation group | Active comparator | Those are patient with rectal cancer who underwent preoperative neoadjuvant chemo radiotherapy before surgery. Receives: Radiation: chemoradiotherapy |
| non radiation group | Active comparator | Those are patient with rectal cancer who did not receive preoperative neoadjuvant chemo radiotherapy before surgery. Receives: Radiation: chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
bowel function
During follow-up of the patients in the outpatient clinic, a designated nurse interviewed the patients using bowel function assessment questionnaires at different time intervals between November 2015-when bowel function assessment was started using MSKCC score-and July 2019. Each patient was interviewed at least twice.
The Memorial Sloan Kettering Cancer Center (MSKCC) questionnaire was used. The MSKCC score questionnaire contains 18 questions divided into three subscales: the frequency subscale with six items, dietary subscale with four items, and urgency/soilage subscale with four items, with four additional single items. Each subscale is scored by adding the scores of each item, and the global score is the sum of all subscale scores. Finally, the total score is calculated by summing the global score and the scores for the four single items with the maximum score of 90. The higher the score the better the function.
Measured: 6 months-24 months
Secondary outcomes (1)
fecal incontinence
During follow-up of the patients in the outpatient clinic, a designated nurse interviewed the patients using fecal incontinence assessment questionnaire at different time intervals between November 2015-when fecal incontinence assessment was started using Wexner score-and July 2019. Each patient was interviewed at least twice.
The Wexner questionnaire was used. Wexner score questionnaire comprises five questions regarding solid, liquid, and gas incontinence; the use of a pad; and lifestyle alterations on a scale of 0-20 (0: no incontinence; 20: complete incontinence). The lower the score, the better the continence.
Measured: 6 months-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start12 Aug 2019
- Primary completion10 Dec 2019
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel; Functional SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Sakr, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339763
- Sponsor's protocol ID
- 4-2019-1098
- Status last verified
- Apr 2022
- First submitted
- 31 Mar 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Bowel Functional Outcomes Following Anal Sphincter Preserving Surgery for Rectal Cancer: A Single Center Longitudinal Study.
- ClinicalTrials.gov ID
- NCT05339763
- Acronym / sponsor ID
- 4-2019-1098
- Conditions
- Bowel; Functional Syndrome, Rectal Cancer
- Keywords
- Rectal cancer, Sphincter preserving surgery, Neoadjuvant therapy, ow anterior resection syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- In this longitudinal study, 171 patients were evaluated and compared based on the radiation therapy they received.
- Bowel function was assessed longitudinally with Memorial Sloan Kettering Cancer Center and Wexner scores every 6 months after restoration of bowel continuity. Patients with at least two follow-up visits were included.
Detailed description
Background Despite advances in the neoadjuvant chemoradiation therapy and anal sphincter-preserving surgeries for rectal cancer, bowel dysfunction is still unavoidable which negatively affect the patients' quality of life. In this longitudinal study, The aim of this study was to investigate the changes in bowel function with follow up time and the effect of the neoadjuvant chemo radiotherapy on bowel function following low anterior resection for rectal cancer.
Materials and methods In this study, 171 patients with rectal cancer who underwent low anterior resection between 2012 and 2018 were included. Bowel function was assessed longitudinally with Memorial Sloan Kettering Cancer Center and Wexner scores every 6 months after restoration of bowel continuity. Patients with at least two follow-up visits were included.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiation group | Active comparator | Radiation: chemoradiotherapyThose are patient with rectal cancer who underwent preoperative neoadjuvant chemo radiotherapy before surgery. |
| non radiation group | Active comparator | Radiation: chemoradiotherapyThose are patient with rectal cancer who did not receive preoperative neoadjuvant chemo radiotherapy before surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of both sexes,
- Aged between 18 and 75 years,
- Patients with mid and upper rectal cancer (6-15) cm from the anal verge(AV) with or without preoperative chemo radiotherapy.
- Patients who underwent low anterior resection(LAR).
- Patients who were followed up with at least two outpatient visits for bowel function assessment.
Key exclusion criteria (7 listed)
- Patients with recurrent rectal tumors,
- Surgically unfit patients,
- Patients with tumors infiltrating the puborectalis muscle or external sphincter.
- Patients with preoperative fecal incontinence.
- Patients who were followed up only once in the outpatient clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chemoradiotherapyAlso: neoadjuvant chemoradiotherapyexposure of patients with rectal cancer to radiotherapy and assessment of their bowel function after surgery | Radiation | non radiation group, radiation group |
Primary outcome
bowel function
Time frame: 6 months-24 months
During follow-up of the patients in the outpatient clinic, a designated nurse interviewed the patients using bowel function assessment questionnaires at different time intervals between November 2015-when bowel function assessment was started using MSKCC score-and July 2019. Each patient was interviewed at least twice. The Memorial Sloan Kettering Cancer Center (MSKCC) questionnaire was used. The MSKCC score questionnaire contains 18 questions divided into three subscales: the frequency subscale with six items, dietary subscale with four items, and urgency/soilage subscale with four items, with four additional single items. Each subscale is scored by adding the scores of each item, and the global score is the sum of all subscale scores. Finally, the total score is calculated by summing the global score and the scores for the four single items with the maximum score of 90. The higher the score the better the function.
1 secondary outcome
fecal incontinence
Time frame: 6 months-24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chemoradiotherapy in people with Bowel; Functional Syndrome and Rectal Cancer, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bowel function (time frame: 6 months-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.