Rectal CancerNCT04730102
Rectal Washout in Transanal Total Mesorectal Excision and Presence of Intraluminal Malignant Cells
An observational study of Rectal Cancer, run by Slagelse Hospital at 1 site in Denmark.
Trial summary
The study aims to assess the existence of intraluminal malignant cells and the appropriate fluid volume needed to perform rectal washout during transanal total mesorectal excision (taTME) for 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?
- Rectal washout
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Feb 2020to 9 Feb 2021
- 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 undergoing transanal mesorectal excision at Slagelse Hospital, Denmark
Who may be able to join
- Surgery at Slagelse Hospital for rectal cancer with transanal mesorectal excision
- Consent to participate in the study
Who cannot join
- No consent to participate
- No surgery
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to assess the existence of intraluminal malignant cells and the appropriate fluid volume needed to perform rectal washout during transanal total mesorectal excision (taTME) for rectal cancer.
Read the detailed description
Twenty patients undergoing taTME for rectal cancer is included. Following the closure of the rectal lumen by a purse string suture, rectal washout is performed with a total of 500 ml sterile water. Fluid samples are collected after every 100 ml by instilling 50 ml of saline after each washout. A sixth sample is collected from the presacral cavity. Each sample is cytologically examined by a pathologist and labelled either malignant or non-malignant.
- Conditions
- Rectal Cancer
- Being tested
- Rectal washout
- Keywords
- Rectal washout, transanal total mesorectal excision, rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal washoutProcedure or surgery
Rectal washout is performed intraoperatively before transection and means irrigation of the rectum following the closure of the rectal lumen below the tumour with a purse string suture. Rectal washout is performed with a total of 500 ml sterile water. Fluid samples are collected after every 100 ml by instilling 50 ml of saline after each washout. A sixth sample is collected from the presacral cavity.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing rectal washout in transanal mesorectal excision | Patients undergoing rectal washout in transanal mesorectal excision for rectal cancer. Receives: Procedure: Rectal washout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Existence of intraluminal malignant cells in fluid samples from rectal washout
Positive/negative cytology
Measured: Intraoperatively
Secondary outcomes (1)
Fluid volume needed to perform rectal washout during transanal total mesorectal excision to eliminate intraluminal malignant cells
Positive/negative cytology
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start13 Feb 2020
- Primary completion9 Feb 2021
- Study completion9 Feb 2021
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.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Slagelse Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Skane University Hospital, Lund University
- Responsible party
- Sponsor
- Investigators
- Pamela Buchwald, Principal investigator, Skåne University Hospital, Malmö, Region Skåne, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730102
- Sponsor's protocol ID
- SJ-817
- Other IDs
- 2019-2567, ALF Region Skåne
- Status last verified
- Feb 2021
- First submitted
- 25 Jan 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Washout in Transanal Total Mesorectal Excision and Presence of Intraluminal Malignant Cells
- ClinicalTrials.gov ID
- NCT04730102
- Acronym / sponsor ID
- SJ-817
- Conditions
- Rectal Cancer
- Keywords
- Rectal washout, transanal total mesorectal excision, rectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Slagelse HospitalUniversity, hospital or other
- Collaborators
- Skane University Hospital, Lund University
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 9 Feb 2021 (actual)
- Study completion
- 9 Feb 2021 (actual)
- First posted
- 29 Jan 2021 (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 study aims to assess the existence of intraluminal malignant cells and the appropriate fluid volume needed to perform rectal washout during transanal total mesorectal excision (taTME) for rectal cancer.
Detailed description
Twenty patients undergoing taTME for rectal cancer is included. Following the closure of the rectal lumen by a purse string suture, rectal washout is performed with a total of 500 ml sterile water. Fluid samples are collected after every 100 ml by instilling 50 ml of saline after each washout. A sixth sample is collected from the presacral cavity. Each sample is cytologically examined by a pathologist and labelled either malignant or non-malignant.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing rectal washout in transanal mesorectal excision | – | Procedure: Rectal washoutPatients undergoing rectal washout in transanal mesorectal excision for rectal cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing transanal mesorectal excision at Slagelse Hospital, Denmark
Key inclusion criteria (2 listed)
- Surgery at Slagelse Hospital for rectal cancer with transanal mesorectal excision
- Consent to participate in the study
Key exclusion criteria (2 listed)
- No consent to participate
- No surgery
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 |
|---|---|---|
| Rectal washoutRectal washout is performed intraoperatively before transection and means irrigation of the rectum following the closure of the rectal lumen below the tumour with a purse string suture. Rectal washout is performed with a total of 500 ml sterile water. Fluid samples are collected after every 100 ml by instilling 50 ml of saline after each washout. A sixth sample is collected from the presacral cavity. | Procedure or surgery | Patients undergoing rectal washout in transanal mesorectal excision |
Primary outcome
Existence of intraluminal malignant cells in fluid samples from rectal washout
Time frame: Intraoperatively
Positive/negative cytology
1 secondary outcome
Fluid volume needed to perform rectal washout during transanal total mesorectal excision to eliminate intraluminal malignant cells
Time frame: Intraoperatively
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 10 Feb 2021.
- 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.
Pamela Buchwald principal investigator
Skåne University Hospital, Malmö, Region Skåne, Sweden
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 Slagelse Hospital at 1 site in Denmark.
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 2 inclusion and 2 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 10 Feb 2021. 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 Denmark. 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?
Existence of intraluminal malignant cells in fluid samples from rectal washout (time frame: Intraoperatively). 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 Feb 2021.