ComplicationD3/CMENCT03776591
Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer
A study testing Open surgery, Right colectomy and Laparoscopic surgery in people with Complication and Quality of Life, run by Haraldsplass Deaconess Hospital at 1 site in Norway.
Trial summary
The primary focus in this study is to investigate and improve the surgical technique. In addition the collection of clinical data during diagnostic and follow up and the collection of tumor and blood gives us the opportunity to investigate tumor biology and its relevance in terms of determine appropriate treatment… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Complication, Quality of Life, Surgical Procedure, Unspecified
- What is being tested?
- Open surgery, Right colectomy and Laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2016to 31 Dec 2026
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients with malignant tumor of the right colon (cecum, ascending colon, right flexure and right transverse) at CT, colonoscopy.
- Patients medically cleared by anesthesiologist for general anesthesia and oncological radical resection
- Patients ≤ 85 years
- Signed informed consent form
Who cannot join
- • Patients with recurrent cancer after previous surgery
- Patients with synchronous distant metastasis
- Patients with ongoing oncological treatment due to other cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open D3 Right Colectomy Compared to Laparoscopic CME Right Colectomy for Right Sided Colon Cancer; an Open Randomized Controlled Study
The primary focus in this study is to investigate and improve the surgical technique. In addition the collection of clinical data during diagnostic and follow up and the collection of tumor and blood gives us the opportunity to investigate tumor biology and its relevance in terms of determine appropriate treatment strategy both surgically and oncological and to assess and predict treatment outcome.
The aim of this study is to compare short and long-term outcomes between open D3 and laparoscopic CME (complete mesocolic excision) with CVL (central vascular ligation) right colectomy for right-sided colon cancer. Our primary hypothesis is that laparoscopic surgery improves quality of life by reducing pain, postoperative complications and thereby reduces hospital stay and convalescence. On the other hand it is to prove non-inferiority of the laparoscopic group compared to the open group by means of oncological outcome (survival, recurrence). Secondary aim is to evaluate surgical quality by comparing actual vascular stump length between the two groups by postoperative CT and compare number of lymph nodes removed with the specimen. With the use of liquid biopsy we want to detect circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) and evaluate their value as tumor markers by comparing the prognostic and predictive value. The hypothesis is that ctDNA and CTCs are more sensitive than standard parameters and imaging (CT CEA).
Read the detailed description
This is a prospective, randomized, multi-center clinical study. The short term outcome, 2 and 5 year survival and mortality rates will be compared between the groups operated with open D3 resection at Haukeland University hospital and laparoscopic CME with CVL right hemicolectomy at Haraldsplass Deaconess hospital. Computer generated block randomization will be used.
All patients ≤ 85 years with tumor localized in the right colon will be considered to participate in the study. The patients will be summoned to the first consultation to the hospital they are referred to. They will be informed of the study. A patient who meets the inclusion criteria will be asked to participate in the study and sign the informed consent. A patient who accepts will be assigned a sequential participant number and then referred to open D3 or laparoscopic CME (right hemicolectomy) according to a pre-specified randomized list of treatments.
All patients referred with right sided colon cancer in the inclusion period will be registered, and the reason why some do not participate in the study will be documented. Patients who decline to participate in the study will be assigned standard treatment in the institution they are referred to.
Blood samples for analysis of ctDNA/CTCs will be collected preoperatively, 3-10th postoperative day, at 3 months and at each check the next five years at six months intervals. All sample times except the first postoperative control, correspond to the time of CEA and CT in ordinary follow-up. Proteomic technology based analysis of tumor tissue
- Conditions
- Complication, Quality of Life, Surgical Procedure, Unspecified, Lymph Node Metastases, Circulating Tumor Cell
- Being tested
- Open surgery, Right colectomy, Laparoscopic surgery, Central lymphadenectomy and vascular ligation
- Keywords
- D3 lymphadenectomy, Right-sided, Colon cancer, Complications, Circulating tumor cells, Circulating DNA (cDNA), Laparoscopy, Complete mesocolic excision
- Medical subject headings
- Lymphatic Metastasis, Neoplastic Cells, Circulating, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open surgeryProcedure or surgery
Right colectomyProcedure or surgery
Laparoscopic surgeryProcedure or surgery
Central lymphadenectomy and vascular ligationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Open D3 | Experimental | Right colectomy Open surgery Central lymphadenectomy and vascular ligation Receives: Procedure: Open surgery; Procedure: Right colectomy; Procedure: Central lymphadenectomy and vascular ligation |
| Laparoscopic CME with CVL | Active comparator | Right colectomy Laparoscopic surgery Central lymphadenectomy and vascular ligation Receives: Procedure: Right colectomy; Procedure: Laparoscopic surgery; Procedure: Central lymphadenectomy and vascular ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Surgical and general complications by Clavien-Dindo Classification og surgical complications
Measured: 30 days
Secondary outcomes (8)
Surgical quality vascular resection
Vascular stump length in mm
Measured: 6 months
Surgical quality lymph nodes
Number of lymph nodes
Measured: 6 months
Patient outcome general
15D Health-related quality of life (HRQoL) preoperative and at 6 months. Scale 0-1. a higher score reflects a better HRQoL
Measured: 6 months
Patient outcome bowel function
Quality of life (LARS (low anterior resection syndrome) score preoperative and at 6 months. Scale 0-42, where 0 reflects no LARS and 30-42 major LARS.
Measured: 6 months
Oncological outcome survival
Survival in months
Measured: 60 months
Oncological outcome recurrence
Time to recurrence in months
Measured: 60 months
Prognostic significance of ctDNA
copies/mL plasma or % fractional abundance (mutant/total ctDNA)
Measured: 60 months
Prognostic significance of CTCs
CTC/ml blood
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start1 Sep 2016
- Primary completion31 Jan 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ComplicationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haraldsplass Deaconess Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse-Bergen HF, University of Bergen
- Responsible party
- Principal investigator, Kristin Bentung Lygre, Haraldsplass Deaconess Hospital
- Investigators
- Kristin B. Lygre, M.D, Study director, Haraldsplass Deaconess Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776591
- Sponsor's protocol ID
- REK 2015/2396
- Acronym
- D3/CME
- Status last verified
- May 2026
- First submitted
- 6 Dec 2018
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lygre KB, Forthun RB, Hoysaeter T, Hjelle SM, Eide GE, Gjertsen BT, Pfeffer F, Hovland R. Assessment of postoperative circulating tumour DNA to predict early recurrence in patients with stage I-III right-sided colon cancer: prospective observational study. BJS Open. 2024 Jan 3;8(1):zrad146. doi: 10.1093/bjsopen/zrad146.
PubMed 38242575Lygre KB, Eide GE, Forsmo HM, Dicko A, Storli KE, Pfeffer F. Complications after open and laparoscopic right-sided colectomy with central lymphadenectomy for colon cancer: randomized controlled trial. BJS Open. 2023 Jul 10;7(4):zrad074. doi: 10.1093/bjsopen/zrad074.
PubMed 37643373
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open D3 Right Colectomy Compared to Laparoscopic CME Right Colectomy for Right Sided Colon Cancer; an Open Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03776591
- Acronym / sponsor ID
- D3/CME / REK 2015/2396
- Conditions
- Complication, Quality of Life, Surgical Procedure, Unspecified, Lymph Node Metastases, Circulating Tumor Cell
- Keywords
- D3 lymphadenectomy, Right-sided, Colon cancer, Complications, Circulating tumor cells, Circulating DNA (cDNA), Laparoscopy, Complete mesocolic excision
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Haraldsplass Deaconess HospitalUniversity, hospital or other
- Collaborators
- Helse-Bergen HF, University of Bergen
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Dec 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 primary focus in this study is to investigate and improve the surgical technique. In addition the collection of clinical data during diagnostic and follow up and the collection of tumor and blood gives us the opportunity to investigate tumor biology and its relevance in terms of determine appropriate treatment strategy both surgically and oncological and to assess and predict treatment outcome.
The aim of this study is to compare short and long-term outcomes between open D3 and laparoscopic CME (complete mesocolic excision) with CVL (central vascular ligation) right colectomy for right-sided colon cancer. Our primary hypothesis is that laparoscopic surgery improves quality of life by reducing pain, postoperative complications and thereby reduces hospital stay and convalescence. On the other hand it is to prove non-inferiority of the laparoscopic group compared to the open group by means of oncological outcome (survival, recurrence). Secondary aim is to evaluate surgical quality by comparing actual vascular stump length between the two groups by postoperative CT and compare number of lymph nodes removed with the specimen. With the use of liquid biopsy we want to detect circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) and evaluate their value as tumor markers by comparing the prognostic and predictive value. The hypothesis is that ctDNA and CTCs are more sensitive than standard parameters and imaging (CT CEA).
Detailed description
This is a prospective, randomized, multi-center clinical study. The short term outcome, 2 and 5 year survival and mortality rates will be compared between the groups operated with open D3 resection at Haukeland University hospital and laparoscopic CME with CVL right hemicolectomy at Haraldsplass Deaconess hospital. Computer generated block randomization will be used.
All patients ≤ 85 years with tumor localized in the right colon will be considered to participate in the study. The patients will be summoned to the first consultation to the hospital they are referred to. They will be informed of the study. A patient who meets the inclusion criteria will be asked to participate in the study and sign the informed consent. A patient who accepts will be assigned a sequential participant number and then referred to open D3 or laparoscopic CME (right hemicolectomy) according to a pre-specified randomized list of treatments.
All patients referred with right sided colon cancer in the inclusion period will be registered, and the reason why some do not participate in the study will be documented. Patients who decline to participate in the study will be assigned standard treatment in the institution they are referred to.
Blood samples for analysis of ctDNA/CTCs will be collected preoperatively, 3-10th postoperative day, at 3 months and at each check the next five years at six months intervals. All sample times except the first postoperative control, correspond to the time of CEA and CT in ordinary follow-up. Proteomic technology based analysis of tumor tissue
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open D3 | Experimental | Procedure: Open surgery, Procedure: Right colectomy, Procedure: Central lymphadenectomy and vascular ligationRight colectomy Open surgery Central lymphadenectomy and vascular ligation |
| Laparoscopic CME with CVL | Active comparator | Procedure: Right colectomy, Procedure: Laparoscopic surgery, Procedure: Central lymphadenectomy and vascular ligationRight colectomy Laparoscopic surgery Central lymphadenectomy and vascular ligation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Patients with malignant tumor of the right colon (cecum, ascending colon, right flexure and right transverse) at CT, colonoscopy.
Key exclusion criteria (3 listed)
- • Patients with recurrent cancer after previous 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 |
|---|---|---|
| Open surgery | Procedure or surgery | Open D3 |
| Right colectomy | Procedure or surgery | Laparoscopic CME with CVL, Open D3 |
| Laparoscopic surgery | Procedure or surgery | Laparoscopic CME with CVL |
| Central lymphadenectomy and vascular ligation | Procedure or surgery | Laparoscopic CME with CVL, Open D3 |
Primary outcome
Complications
Time frame: 30 days
Surgical and general complications by Clavien-Dindo Classification og surgical complications
8 secondary outcomes
Surgical quality vascular resection
Time frame: 6 months
Surgical quality lymph nodes
Time frame: 6 months
Patient outcome general
Time frame: 6 months
Patient outcome bowel function
Time frame: 6 months
Oncological outcome survival
Time frame: 60 months
Oncological outcome recurrence
Time frame: 60 months
Prognostic significance of ctDNA
Time frame: 60 months
Prognostic significance of CTCs
Time frame: 60 months
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 14 May 2026.
- Derived from this study: PubMed 38242575Lygre KB, Forthun RB, Hoysaeter T, Hjelle SM, Eide GE, Gjertsen BT, Pfeffer F, Hovland R. Assessment of postoperative circulating tumour DNA to predict early recurrence in patients with stage I-III right-sided colon cancer: prospective observational study. BJS Open. 2024 Jan 3;8(1):zrad146. doi: 10.1093/bjsopen/zrad146.
- Derived from this study: PubMed 37643373Lygre KB, Eide GE, Forsmo HM, Dicko A, Storli KE, Pfeffer F. Complications after open and laparoscopic right-sided colectomy with central lymphadenectomy for colon cancer: randomized controlled trial. BJS Open. 2023 Jul 10;7(4):zrad074. doi: 10.1093/bjsopen/zrad074.
- 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.
Kristin B. Lygre, M.D study director
Haraldsplass Deaconess Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open surgery, Right colectomy and Laparoscopic surgery in people with Complication and Quality of Life, run by Haraldsplass Deaconess Hospital at 1 site in Norway.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 14 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 Norway. 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?
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?
Complications (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 NCT03776591, which also lists 2 linked publications.
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 14 May 2026.