Right Colectomy for Colon Cancer Database (RCC). Surgical Technique, Route of Access and Quality of the Specimen

NCT06329102 | Recruiting DMC

• 1 other identifier: 93628
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the project is to surveil results after extended lymphadenectomy for right sided colon resection for cancer with different operative techniques. Patients operated for right sided colon cancer will be involved. There are different operative methods used in terms of extend of lymphadenectomy and access (open, laparoscopic and robotic assisted) that are already implemented. The Norwegian standard operation contains less extended lymph node dissection. Patients operated by the standard method will serve as control group. Choice of access and extend of lymph node dissection in Norway is dependant on the surgeon and hospital. At Haukeland University Hospital extend and access of surgery are determined by a multidisciplinary team meeting. More radical surgery might result in more complications and the benefit for the patients in terms of oncological result and survival is uncertain. At Haukeland University Hospital, extended lymphadenectomy has been mostly performed by open surgery. During the study phase we will introduce extended lymphadenectomy by laparoscopy and robotassisted surgery. Hypothesis is that more radical surgery performed by minimal invasive surgery will result in equal or better oncological results, and less complications, shorter hospital stay and better quality of life. As method we choose a prospective observational study. All eligible patients with adenocarcinoma of the right colon without another ongoing oncological treatment for other cancers will be included. Patientdata will be prospectively registered in a web-based database. Aim of the study will be to define the optimal extend of lymphadenectomy to achieve the best oncological result. In addition, we will analyse the results dependent on the surgical access (open, laparoscopic or robotic). The assumed difference between the operative methods is small. Therefore, the study is designed and approved as a multicenter registration in order to achieve the necessary statistical power.

Conditions

Right Sided Colon Cancer; Right Colectomy; Lymphadenectomy

Outcome Measures

Primary Outcomes (1)

• Surgical complications defined by Calvien Dindo II to V

  The primary aim of the project is to compare the impact of surgical radicality on clinical outcomes for right-sided colon cancer. The Clavien Dindo classification is a validated system ranging from I-V.

  From the operation to discharge and readmission within 30 days

Secondary Outcomes (3)

• Surgical quality described by the specimen quality and number of lymph nodes harvested

  Postoperatively

• Oncological quality will be measured by overall survival and recurrence

  Postoperatively up to five years

• Quality of life after surgery measured with the 15D instrument

  2021 to 2024

Study Arms (3)

Access (Open, laparoscopic, robotic)

Outcomes will be analysed for the different groups

Procedure: Surgical access

Extend of lymphadenectomy described by VAS score

The extend of lymphadenectomy achieved will be described by a visual analogue scale (VAS) after the operation

Procedure: Surgical access

Quality of the specimen

The quality of the specimen will be documented postoperatively by a graded classification system

Procedure: Surgical access

Interventions

Surgical access PROCEDURE

Complications by Clavien Dindo Number of lymph nodes. Disease free and Overall survival

Also known as: Complications, oncological outcome, survival

Access (Open, laparoscopic, robotic); Extend of lymphadenectomy described by VAS score; Quality of the specimen

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with confirmed adenocarcinom of the right colon admitted to the hospital

You may qualify if:

• Patients with malignant tumor of the right colon at CT and/or colonoscopy.
• Confirmed adenocarcinoma
• Patients medically cleared by anesthesiologist for general anesthesia and oncological radical resection
• Informed consent

You may not qualify if:

• Patients under 18 years
• Patients with recurrent cancer after previous surgery
• Patients with ongoing treatment due to other cancer

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Intuitive Surgical: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 5009, Norway

RECRUITING

Related Publications (5)

• Lygre 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.

  PMID: 37643373 BACKGROUND

• Lygre KB, Eide GE, Liedenbaum MH, Augland IMB, Haldorsen IS, Pfeffer F. Short and equal vascular stump length after standardized laparoscopic and open surgery with central lymphadenectomy for right-sided colon cancer. Br J Surg. 2024 Jan 3;111(1):znad410. doi: 10.1093/bjs/znad410. No abstract available.

  PMID: 38064678 BACKGROUND

• Sintonen H. The 15D instrument of health-related quality of life: properties and applications. Ann Med. 2001 Jul;33(5):328-36. doi: 10.3109/07853890109002086.

  PMID: 11491191 BACKGROUND

• Benz S, Tannapfel A, Tam Y, Grunenwald A, Vollmer S, Stricker I. Proposal of a new classification system for complete mesocolic excison in right-sided colon cancer. Tech Coloproctol. 2019 Mar;23(3):251-257. doi: 10.1007/s10151-019-01949-4. Epub 2019 Mar 5.

  PMID: 30838463 BACKGROUND

• Pfeffer F, Kalgraff P, Lygre KB, Nedrebo BS, Forsmo HM. Proposal of a new visual analogue scale to describe the extent of lymphadenectomy in right-sided colectomy for cancer-a prospective observational study. Tech Coloproctol. 2025 Sep 2;29(1):166. doi: 10.1007/s10151-025-03182-8.

  PMID: 40892141 DERIVED

MeSH Terms

Interventions

Minimally Invasive Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Frank Pfeffer, Prof

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank Pfefer, Prof

CONTACT

48180021; frank.pfeffer@helse-bergen.no

Havard Forsmo, PhD

CONTACT

48276232; havard.mjorud.forsmo@helse-bergen.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: January 1, 2021
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2024-2024
• Access Criteria: signed cooperation agreement

Locations

NO (1)