Colo-rectal CancerNCT04223141
Single-stapled Double Purse-string Technique for Colorectal Anastomosis
A study testing SIA in people with Colo-rectal Cancer, run by Vejle Hospital at 1 site in Denmark.
Trial summary
A single-arm, single-center prospective study of a novel double purse-string technique for constructing the colorectal anastomosis in robot-assisted laparoscopic resection of the sigmoid colon for cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- SIA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Mar 2020to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Verified cancer of the sigmoid colon
- Planned elective robot-assisted laparoscopic resection of sigmoid colon with primary anastomosis
- Operation with curative intent
Who cannot join
- Not legally competent and/or < 18 years old
- Not able to comprehend information and/or give written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-stapled Double Purse-string Anastomotic (SIA) Technique in Robotic Malignant Sigmoid Resections
A single-arm, single-center prospective study of a novel double purse-string technique for constructing the colorectal anastomosis in robot-assisted laparoscopic resection of the sigmoid colon for cancer.
Read the detailed description
In all, 30 consecutive patients will be enrolled. The first 5 will be regarded as a pilot series for testing and aligning the study setup. The next 25 patients will form the study group. The clinical outcomes will be compared with historical control patients from our own department. Safety and feasibility will be assessed by short-term clinical outcomes.
- Conditions
- Colo-rectal Cancer
- Being tested
- SIA
- Keywords
- Robot
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIAProcedure or surgery
As indicated by arm description
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Robot-assisted laparoscopic resection of sigmoid colon with colorectal anastomosis constructed by the double purse-string technique Receives: Procedure: SIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Successful construction of anastomosis by double purse-string technique
Measured: 30 days
Complications
Surgical complications graded by Clavien-Dindo
Measured: 30 days
Mortality
Postoperative death
Measured: 30 days
Secondary outcomes (5)
LOS
Length of stay - number of days from day of operation to discharge
Measured: 90 days
Readmissions
Unplanned hospital admissions at least 24 hs after discharge
Measured: 30 days
Operation time
Duration of operation from incision to last skin stitch
Measured: 30 days
Blood loss
Estimated intraoperative blood loss in ml
Measured: 30 days
Medical complications
Medical complications graded by Clavien-Dindo and MESS
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start17 Mar 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene J Würtz, MD, Principal investigator, Staff SurgeonFlemming H Dall, MD PhD, Principal investigator, ConsultantHans B Rahr, MD DMSc, Study director, Department Head
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223141
- Sponsor's protocol ID
- SIA2020
- Status last verified
- Apr 2026
- First submitted
- 7 Jan 2020
- Last updated
- 6 May 2026
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-stapled Double Purse-string Anastomotic (SIA) Technique in Robotic Malignant Sigmoid Resections
- ClinicalTrials.gov ID
- NCT04223141
- Acronym / sponsor ID
- SIA2020
- Conditions
- Colo-rectal Cancer
- Keywords
- Robot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 10 Jan 2020 (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.
A single-arm, single-center prospective study of a novel double purse-string technique for constructing the colorectal anastomosis in robot-assisted laparoscopic resection of the sigmoid colon for cancer.
Detailed description
In all, 30 consecutive patients will be enrolled. The first 5 will be regarded as a pilot series for testing and aligning the study setup. The next 25 patients will form the study group. The clinical outcomes will be compared with historical control patients from our own department. Safety and feasibility will be assessed by short-term clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: SIARobot-assisted laparoscopic resection of sigmoid colon with colorectal anastomosis constructed by the double purse-string technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Verified cancer of the sigmoid colon
- Planned elective robot-assisted laparoscopic resection of sigmoid colon with primary anastomosis
- Operation with curative intent
Key exclusion criteria (2 listed)
- Not legally competent and/or < 18 years old
- Not able to comprehend information and/or give written consent
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 |
|---|---|---|
| SIAAs indicated by arm description | Procedure or surgery | Study group |
Primary outcome
Technical success
Time frame: 30 days
Successful construction of anastomosis by double purse-string technique
Complications
Time frame: 30 days
Surgical complications graded by Clavien-Dindo
Mortality
Time frame: 30 days
Postoperative death
5 secondary outcomes
LOS
Time frame: 90 days
Readmissions
Time frame: 30 days
Operation time
Time frame: 30 days
Blood loss
Time frame: 30 days
Medical complications
Time frame: 30 days
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 6 May 2026.
- 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.
Helene J Würtz, MD principal investigator
Staff Surgeon
Flemming H Dall, MD PhD principal investigator
Consultant
Hans B Rahr, MD DMSc study director
Department Head
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIA in people with Colo-rectal Cancer, run by Vejle 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 3 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 6 May 2026. 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?
Technical success (time frame: 30 days). The study lists 3 primary outcomes in all. 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 6 May 2026.