Rectal CancerNCT03487484
Quality of Life in Patients With Rectal Cancer Receiving Total Mesorectal Excision With or Without Stoma
An observational study of Rectal Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with total mesorectal excision (TME) and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Quality of Life Questionnaire for gastrointestinal tract, Quality of Life Questionnaire and Faecal Incontinence Score
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Mar 2018to 22 Mar 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed rectal cancer
Who may be able to join
- age older than 18,
- low anterior resection and TME due to rectum carcinoma after standardized neoadjuvant combined chemo- and radiotherapy and receiving adjuvant postoperative chemotherapy,
- German speaking patient who is capable to fill in the questionnaire,
- signed informed consent
Who cannot join
- age younger than 18,
- preoperative stoma,
- not German speaking
- inability to fill in the questionnaire,
- no standardized chemo- and radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life in Patients With Rectal Cancer Receiving Neoadjuvant Chemotherapy, Total Mesorectal Excision With or Without Stoma and Adjuvant Chemotherapy: a Prospective, Single-centre Pilot-study
The goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with total mesorectal excision (TME) and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer.
Read the detailed description
In most cases it is recommended that patients after low anterior resection with TME and neoadjuvant chemoradiotherapy for rectal cancer need a temporarily diverting stoma. Recent evidence suggests that this is not always necessary. The decision for or against a stoma is made by the surgeon in charge and is based on an algorithm of risk factors for anastomotic leakage. Many patients receive an adjuvant chemotherapy postoperative. This may influence the quality of life e.a. due to mucositis and urge incontinency or the stoma itself.The objective of this pilot study is to establish the basis for a randomized controlled trial. The long-term goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with TME and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer. All patients scheduled for low anterior resection of the rectum for rectal carcinoma will be invited to participate and prospectively enrolled into the study.
- Conditions
- Rectal Cancer
- Being tested
- Quality of Life Questionnaire for gastrointestinal tract, Quality of Life Questionnaire, Faecal Incontinence Score
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life Questionnaire for gastrointestinal tractBehavioural
Also called GIQLI questionnaire
To assess quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index) will be applied
Quality of Life QuestionnaireBehavioural
Also called SF-36 questionnaire
To assess quality of life, the SF-36 questionnaire will be applied
Faecal Incontinence ScoreBehavioural
Also called Vaizey Wexner questionnaire
To assess faecal incontinence, the Vaizey Wexner questionnaire will be applied
| Study group | Role | What they receive |
|---|---|---|
| With protective stoma | Patients in which intraoperatively the decision was made to add a protective stoma (following a risk algorithm) to total mesorectal excision. In patients quality of life, the Gastrointestinal Quality of Life Index (GIQLI) questionnaire, Quality of Life Questionnaire for gastrointestinal tract and Faecal Incontinence Score will be applied. Receives: Behavioral: Quality of Life Questionnaire for gastrointestinal tract; Behavioral: Quality of Life Questionnaire; Behavioral: Faecal Incontinence Score | |
| No stoma | Patients in which intraoperatively the decision was made to refrain from adding a protective stoma (following a risk algorithm) to total mesorectal excision.
In patients quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index), Quality of Life Questionnaire for gastrointestinal tract and Faecal Incontinence Score will be applied. Receives: Behavioral: Quality of Life Questionnaire for gastrointestinal tract; Behavioral: Quality of Life Questionnaire; Behavioral: Faecal Incontinence Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life specific for the gastrointestinal tract
GIQLI Score
Measured: at Baseline and up to 12 months after surgery
Secondary outcomes (2)
Change in quality of life
Short Form (SF) 36
Measured: at Baseline and up to 12 months after surgery
Change in faecal Incontinence
Vaizey Wexner Score
Measured: at Baseline and up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start22 Mar 2018
- Primary completion22 Mar 2020
- Study completion22 Mar 2020
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanne Drews, MD, Principal investigator, Claraspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487484
- Sponsor's protocol ID
- QoL Rectal Cancer
- Status last verified
- Apr 2020
- First submitted
- 26 Mar 2018
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Patients With Rectal Cancer Receiving Neoadjuvant Chemotherapy, Total Mesorectal Excision With or Without Stoma and Adjuvant Chemotherapy: a Prospective, Single-centre Pilot-study
- ClinicalTrials.gov ID
- NCT03487484
- Acronym / sponsor ID
- QoL Rectal Cancer
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 22 Mar 2020 (actual)
- Study completion
- 22 Mar 2020 (actual)
- First posted
- 4 Apr 2018 (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.
The goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with total mesorectal excision (TME) and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer.
Detailed description
In most cases it is recommended that patients after low anterior resection with TME and neoadjuvant chemoradiotherapy for rectal cancer need a temporarily diverting stoma. Recent evidence suggests that this is not always necessary. The decision for or against a stoma is made by the surgeon in charge and is based on an algorithm of risk factors for anastomotic leakage. Many patients receive an adjuvant chemotherapy postoperative. This may influence the quality of life e.a. due to mucositis and urge incontinency or the stoma itself.The objective of this pilot study is to establish the basis for a randomized controlled trial. The long-term goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with TME and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer. All patients scheduled for low anterior resection of the rectum for rectal carcinoma will be invited to participate and prospectively enrolled into the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With protective stoma | – | Behavioral: Quality of Life Questionnaire for gastrointestinal tract, Behavioral: Quality of Life Questionnaire, Behavioral: Faecal Incontinence ScorePatients in which intraoperatively the decision was made to add a protective stoma (following a risk algorithm) to total mesorectal excision. In patients quality of life, the Gastrointestinal Quality of Life Index (GIQLI) questionnaire, Quality of Life Questionnaire for gastrointestinal tract and Faecal Incontinence Score will be applied. |
| No stoma | – | Behavioral: Quality of Life Questionnaire for gastrointestinal tract, Behavioral: Quality of Life Questionnaire, Behavioral: Faecal Incontinence ScorePatients in which intraoperatively the decision was made to refrain from adding a protective stoma (following a risk algorithm) to total mesorectal excision. In patients quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index), Quality of Life Questionnaire for gastrointestinal tract and Faecal Incontinence Score will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed rectal cancer
Key inclusion criteria (4 listed)
- age older than 18,
- low anterior resection and TME due to rectum carcinoma after standardized neoadjuvant combined chemo- and radiotherapy and receiving adjuvant postoperative chemotherapy,
- German speaking patient who is capable to fill in the questionnaire,
- signed informed consent
Key exclusion criteria (5 listed)
- age younger than 18,
- preoperative stoma,
- not German speaking
- inability to fill in the questionnaire,
- no standardized chemo- and radiotherapy
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 |
|---|---|---|
| Quality of Life Questionnaire for gastrointestinal tractAlso: GIQLI questionnaireTo assess quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index) will be applied | Behavioural | No stoma, With protective stoma |
| Quality of Life QuestionnaireAlso: SF-36 questionnaireTo assess quality of life, the SF-36 questionnaire will be applied | Behavioural | No stoma, With protective stoma |
| Faecal Incontinence ScoreAlso: Vaizey Wexner questionnaireTo assess faecal incontinence, the Vaizey Wexner questionnaire will be applied | Behavioural | No stoma, With protective stoma |
Primary outcome
Change in quality of life specific for the gastrointestinal tract
Time frame: at Baseline and up to 12 months after surgery
GIQLI Score
2 secondary outcomes
Change in quality of life
Time frame: at Baseline and up to 12 months after surgery
Change in faecal Incontinence
Time frame: at Baseline and up to 12 months after surgery
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Susanne Drews, MD principal investigator
Claraspital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 10 Apr 2020. 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 Switzerland. 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 was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
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?
Change in quality of life specific for the gastrointestinal tract (time frame: at Baseline and up to 12 months after surgery). 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 10 Apr 2020.