Colonic CarcinomaRightNCT04889456
Standardizing Right Hemicolectomy for Colon Cancer
A study testing Implementation standardised laparoscopic right hemicolectomy with proctoring and Implementation standardised laparoscopic right hemicolectomy without proctoring in people with Colonic Carcinoma and Laparoscopic Right Hemicolectomy, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
A surgical intervention might be highly variable amongst surgeons and centers. This variability has a potential relevance concerning clinical outcomes. For right-sided colon cancer, the laparoscopic right hemicolectomy (LRHC) knows substantial variation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Carcinoma, Laparoscopic Right Hemicolectomy, Standardisation
- What is being tested?
- Implementation standardised laparoscopic right hemicolectomy with proctoring and Implementation standardised laparoscopic right hemicolectomy without proctoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 930 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2021to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Planned laparoscopic (extended) right hemicolectomy for colon cancer of the caecum, ascending colon or hepatic flexure;
- Age above 18 years;
- cTNM stage 1-3 (CT-staged);
- No prior midline or transverse laparotomy;
- ASA1-3;
- No immune modulating medication.
Who cannot join
- cT4b;
- Perforated disease;
- Acute obstruction;
- Emergency operation;
- Appendiceal cancer;
- Other primary malignancy treated within 5 years from diagnosis of colon cancer, except for curatively treated prostate, breast, skin and cervical cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Amsterdam UMC, location VUmc
Amsterdam, North Holland, 1081 HV
Alexander A.J. Grüter, MD, +316 45552015, alexandergruter@hotmail.com
Usha K. Coblijn, MD, PhD, +316 43469794, usha.coblijn@gmail.com
About this study
Official title: Implementation of Optimized and Standardized Surgical Technique for Right Sided Colon Cancer: a Prospective Interventional Sequential Cohort Study With a Transition Period
A surgical intervention might be highly variable amongst surgeons and centers. This variability has a potential relevance concerning clinical outcomes.
For right-sided colon cancer, the laparoscopic right hemicolectomy (LRHC) knows substantial variation. Especially since the surgical technique has been evolving during the latest decade with the introduction of intracorporeal anastomosis, a dissection technique within the correct embryological planes (complete mesocolic excision) and central vascular ligation of the segmental branches at its origin, resulting in an optimal lymph node dissection.
Read more
Given the insights from recent studies showing the association between quality of surgery and relevant clinical outcomes, there is a great need for a formative quality assessment of LRHC. Detailed objective assessment of the LRHC is currently not performed in clinical practice nor in surgical training. Quality assessment of LRHC has great potential to improve surgical training and furthermore, implementation of a standardized technique will ultimately lead to better quality of care for patients suffering from right-sided colon cancer.
The main objective of this study is to improve surgical outcomes for patient with right-sided colon cancer by a prospective sequential interventional cohort study that aims to standardize the surgical technique with subsequent controlled implementation after standardized review of the current practice in a nationwide multicenter setting. The primary endpoint is the 30-day morbidity according to the Clavien-Dindo classification system.
Read the detailed description
- Prospective mapping of current practice with surgical variations in laparoscopic right hemicolectomy (total duration of inclusion 3 months) N= 40 centers N = 310 videos
- METC approval for the use of anonymized videos of a laparoscopic procedure and collection of corresponding clinical outcomes.
- Approaching hospitals for participation (high volume centers (50+ colon cancers).
- Prospective inclusion of consecutive patients undergoing laparoscopic right hemicolectomy in the participating hospitals in three months.
- Development of Standard Laparoscopic Right Hemicolectomy: an (inter)national Delphi study
- Approaching specialists to participate in the Delphi method (from participating hospitals in step 1).
- Identification of crucial steps and measures according to literature and expert's opinion (Delphi method).
- Documentation of steps and the order in which they need to be performed, development of a competency assessment tool (CAT).
- Skills center training facility
- Training the participating surgeons in the method of the standardized laparoscopic right hemicolectomy, as consented in the Delphi method.
- Implementation of the standardized laparoscopic right hemicolectomy with proctoring during another period with prospective inclusion of consecutive patients with collection of surgical videos in all participating hospitals (N=40 centers, total 310 videos)
- Rating videos.
- Comparing with pre-implementation performance based on outcome measures reflecting oncological quality of surgery, and 30-day clinical outcomes.
- Comparing with pre-implementation performance based on the long-term outcomes. (3-year DFS and 5-year OS).
- Implementing standardised lap right hemicolectomy (after learning curve without proctoring)
- Consecutive inclusion of patients (n=310)
- CT imaging
- Video analysis
- Competency analysis
- Variation analysis
- Clinico pathological data
- Conditions
- Colonic Carcinoma, Laparoscopic Right Hemicolectomy, Standardisation, Training, Delphi Study, Implementation
- Being tested
- Implementation standardised laparoscopic right hemicolectomy with proctoring, Implementation standardised laparoscopic right hemicolectomy without proctoring
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation standardised laparoscopic right hemicolectomy with proctoringProcedure or surgery
Implementation standardised laparoscopic right hemicolectomy with proctoring
Implementation standardised laparoscopic right hemicolectomy without proctoringProcedure or surgery
Implementation standardised laparoscopic right hemicolectomy without proctoring
| Study group | Role | What they receive |
|---|---|---|
| Surgical variations laparoscopic right hemicolectomy | No intervention | Not described |
| Implementing standardised laparoscopic right hemicolectomy with proctoring | Active comparator | Not described Receives: Procedure: Implementation standardised laparoscopic right hemicolectomy with proctoring |
| Implementing standardised laparoscopic right hemicolectomy without proctoring | Active comparator | Not described Receives: Procedure: Implementation standardised laparoscopic right hemicolectomy without proctoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day morbidity with Clavien-Dindo grading
Measured: 30 days
Secondary outcomes (16)
Intraoperative complications (i.e. vascular injury)
Measured: 1 day
Conversion rate from laparoscopic to open surgery
Measured: 1 day
Operative time
Measured: 1 day
Blood loss
Measured: 1 day
Validated assessment of plane of dissection
Assessment according to a competency assessment tool (CAT) for laparoscopic right hemicolectomy. This tool will be created during phase 2 using the Delphi method.
Measured: 1 day
Validated assessment of level of vascular ligation
Assessment according to a competency assessment tool (CAT) for laparoscopic right hemicolectomy. This tool will be created during phase 2 using the Delphi method.
Measured: 1 day
Grading of the resection specimen according to Benz et al. 2019
Measured: 1 day
Total lymph node count
Measured: 1 day
Number of resected positive lymph nodes
Measured: 1 day
Resection margins
Radicality of resection margin of the specimen, as assessed by the pathologist.
Measured: 1 day
Completeness of mesocolic excision based on postoperative CT imaging
Measured: 1 day
Locoregional recurrence
Measured: 3 years
Distant metastasis
Measured: 3 years
3-year disease free survival (DFS)
Measured: 3 years
5-year overall survival (OS)
Measured: 5 years
Long term morbidity: incisional hernia, adhesion related small bowel obstruction, readmissions, reinterventions
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic CarcinomaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- A prospective interventional sequential cohort study with a transition period
- Masking
- None (open label)
- Enrolment
- 930 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. dr. P.J. Tanis, colorectal surgeon, Dr. B.R. Toorenvliet, colorectal surgeon, D. Miskovic, St Marks hospital London, UK, S. Benz, Klinikverbund SuedWest, Böblingen, Germany, F. Aigner, Krankenhaus der Barmherzigen Bruder, Graz, Austria, C.A. Bertelsen, Hillerød University Hospital, Copenhagen, Denmark, Drs. A.A.J. Grüter, Dr. U.K. Coblijn, Dr. H.L. van Westreenen, Dr. C. Sietses, Prof. dr. E.C.J. Consten, Dr. A.W.H. van de Ven, Dr. P. van Duijvendijk, Dr. S. van Aalten, Dr. F. den Boer, Dr. J.W.A. Leijtens, Dr. C. Hoff, Dr. O. van Ruler, Dr. G. D. Slooter, Prof. dr. J. Lange, Prof. dr. G.J. Kleinrensink
- Responsible party
- Principal investigator, Jurriaan B. Tuynman, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889456
- Sponsor's protocol ID
- 2021.0273
- Acronym
- Right
- Status last verified
- May 2021
- First submitted
- 30 Apr 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gruter AAJ, Coblijn UK, Toorenvliet BR, Tanis PJ, Tuynman JB; Right Collaborators Group. National implementation of an optimal standardised technique for right-sided colon cancer: protocol of an interventional sequential cohort study (Right study). Tech Coloproctol. 2023 Nov;27(11):1083-1090. doi: 10.1007/s10151-023-02801-6. Epub 2023 Apr 25.
PubMed 37097330
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Optimized and Standardized Surgical Technique for Right Sided Colon Cancer: a Prospective Interventional Sequential Cohort Study With a Transition Period
- ClinicalTrials.gov ID
- NCT04889456
- Acronym / sponsor ID
- Right / 2021.0273
- Conditions
- Colonic Carcinoma, Laparoscopic Right Hemicolectomy, Standardisation, Training, Delphi Study, Implementation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 930 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Prof. dr. P.J. Tanis, colorectal surgeon, Dr. B.R. Toorenvliet, colorectal surgeon, D. Miskovic, St Marks hospital London, UK, S. Benz, Klinikverbund SuedWest, Böblingen, Germany, F. Aigner, Krankenhaus der Barmherzigen Bruder, Graz, Austria, C.A. Bertelsen, Hillerød University Hospital, Copenhagen, Denmark, Drs. A.A.J. Grüter, Dr. U.K. Coblijn, Dr. H.L. van Westreenen, Dr. C. Sietses, Prof. dr. E.C.J. Consten, Dr. A.W.H. van de Ven, Dr. P. van Duijvendijk, Dr. S. van Aalten, Dr. F. den Boer, Dr. J.W.A. Leijtens, Dr. C. Hoff, Dr. O. van Ruler, Dr. G. D. Slooter, Prof. dr. J. Lange, Prof. dr. G.J. Kleinrensink
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 17 May 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.
A surgical intervention might be highly variable amongst surgeons and centers. This variability has a potential relevance concerning clinical outcomes.
For right-sided colon cancer, the laparoscopic right hemicolectomy (LRHC) knows substantial variation. Especially since the surgical technique has been evolving during the latest decade with the introduction of intracorporeal anastomosis, a dissection technique within the correct embryological planes (complete mesocolic excision) and central vascular ligation of the segmental branches at its origin, resulting in an optimal lymph node dissection.
Given the insights from recent studies showing the association between quality of surgery and relevant clinical outcomes, there is a great need for a formative quality assessment of LRHC. Detailed objective assessment of the LRHC is currently not performed in clinical practice nor in surgical training. Quality assessment of LRHC has great potential to improve surgical training and furthermore, implementation of a standardized technique will ultimately lead to better quality of care for patients suffering from right-sided colon cancer.
The main objective of this study is to improve surgical outcomes for patient with right-sided colon cancer by a prospective sequential interventional cohort study that aims to standardize the surgical technique with subsequent controlled implementation after standardized review of the current practice in a nationwide multicenter setting. The primary endpoint is the 30-day morbidity according to the Clavien-Dindo classification system.
Detailed description
- Prospective mapping of current practice with surgical variations in laparoscopic right hemicolectomy (total duration of inclusion 3 months) N= 40 centers N = 310 videos
- METC approval for the use of anonymized videos of a laparoscopic procedure and collection of corresponding clinical outcomes.
- Approaching hospitals for participation (high volume centers (50+ colon cancers).
- Prospective inclusion of consecutive patients undergoing laparoscopic right hemicolectomy in the participating hospitals in three months.
- Development of Standard Laparoscopic Right Hemicolectomy: an (inter)national Delphi study
- Approaching specialists to participate in the Delphi method (from participating hospitals in step 1).
- Identification of crucial steps and measures according to literature and expert's opinion (Delphi method).
- Documentation of steps and the order in which they need to be performed, development of a competency assessment tool (CAT).
- Skills center training facility
- Training the participating surgeons in the method of the standardized laparoscopic right hemicolectomy, as consented in the Delphi method.
- Implementation of the standardized laparoscopic right hemicolectomy with proctoring during another period with prospective inclusion of consecutive patients with collection of surgical videos in all participating hospitals (N=40 centers, total 310 videos)
- Rating videos.
- Comparing with pre-implementation performance based on outcome measures reflecting oncological quality of surgery, and 30-day clinical outcomes.
- Comparing with pre-implementation performance based on the long-term outcomes. (3-year DFS and 5-year OS).
- Implementing standardised lap right hemicolectomy (after learning curve without proctoring)
- Consecutive inclusion of patients (n=310)
- CT imaging
- Video analysis
- Competency analysis
- Variation analysis
- Clinico pathological data
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A prospective interventional sequential cohort study with a transition period
| Arm | Type | Receives |
|---|---|---|
| Surgical variations laparoscopic right hemicolectomy | No intervention | – |
| Implementing standardised laparoscopic right hemicolectomy with proctoring | Active comparator | Procedure: Implementation standardised laparoscopic right hemicolectomy with proctoring |
| Implementing standardised laparoscopic right hemicolectomy without proctoring | Active comparator | Procedure: Implementation standardised laparoscopic right hemicolectomy without proctoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Planned laparoscopic (extended) right hemicolectomy for colon cancer of the caecum, ascending colon or hepatic flexure;
- Age above 18 years;
- cTNM stage 1-3 (CT-staged);
- No prior midline or transverse laparotomy;
- ASA1-3;
Key exclusion criteria (6 listed)
- cT4b;
- Perforated disease;
- Acute obstruction;
- Emergency operation;
- Appendiceal cancer;
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 |
|---|---|---|
| Implementation standardised laparoscopic right hemicolectomy with proctoringImplementation standardised laparoscopic right hemicolectomy with proctoring | Procedure or surgery | Implementing standardised laparoscopic right hemicolectomy with proctoring |
| Implementation standardised laparoscopic right hemicolectomy without proctoringImplementation standardised laparoscopic right hemicolectomy without proctoring | Procedure or surgery | Implementing standardised laparoscopic right hemicolectomy without proctoring |
Primary outcome
30-day morbidity with Clavien-Dindo grading
Time frame: 30 days
16 secondary outcomes
Intraoperative complications (i.e. vascular injury)
Time frame: 1 day
Conversion rate from laparoscopic to open surgery
Time frame: 1 day
Operative time
Time frame: 1 day
Blood loss
Time frame: 1 day
Validated assessment of plane of dissection
Time frame: 1 day
Validated assessment of level of vascular ligation
Time frame: 1 day
Grading of the resection specimen according to Benz et al. 2019
Time frame: 1 day
Total lymph node count
Time frame: 1 day
Number of resected positive lymph nodes
Time frame: 1 day
Resection margins
Time frame: 1 day
Completeness of mesocolic excision based on postoperative CT imaging
Time frame: 1 day
Locoregional recurrence
Time frame: 3 years
Distant metastasis
Time frame: 3 years
3-year disease free survival (DFS)
Time frame: 3 years
5-year overall survival (OS)
Time frame: 5 years
Long term morbidity: incisional hernia, adhesion related small bowel obstruction, readmissions, reinterventions
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Derived from this study: PubMed 37097330Gruter AAJ, Coblijn UK, Toorenvliet BR, Tanis PJ, Tuynman JB; Right Collaborators Group. National implementation of an optimal standardised technique for right-sided colon cancer: protocol of an interventional sequential cohort study (Right study). Tech Coloproctol. 2023 Nov;27(11):1083-1090. doi: 10.1007/s10151-023-02801-6. Epub 2023 Apr 25.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation standardised laparoscopic right hemicolectomy with proctoring and Implementation standardised laparoscopic right hemicolectomy without proctoring in people with Colonic Carcinoma and Laparoscopic Right Hemicolectomy, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 May 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day morbidity with Clavien-Dindo grading (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04889456, which also lists 1 linked publication.
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 17 May 2021.