Clinical trial · Interventional
Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer
Open D3 Right Colectomy Compared to Laparoscopic CME Right Colectomy for Right Sided Colon Cancer; an Open Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Circulating Tumor Cell | — | UNRESOLVED | — |
| Complication | — | UNRESOLVED | — |
| Lymph Node Metastases | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Surgical Procedure, Unspecified | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Central lymphadenectomy and vascular ligation | Procedure | — | UNRESOLVED |
| Laparoscopic surgery | Procedure | — | UNRESOLVED |
| Open surgery | Procedure | — | UNRESOLVED |
| Right colectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Open D3
- description
- Right colectomy Open surgery Central lymphadenectomy and vascular ligation
- interventionNames
- Procedure: Open surgery
- Procedure: Right colectomy
- Procedure: Central lymphadenectomy and vascular ligation
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic CME with CVL
- description
- Right colectomy Laparoscopic surgery Central lymphadenectomy and vascular ligation
- interventionNames
- Procedure: Right colectomy
- Procedure: Laparoscopic surgery
- Procedure: Central lymphadenectomy and vascular ligation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * • 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 Exclusion Criteria: * • Patients with recurrent cancer after previous surgery * Patients with synchronous distant metastasis * Patients with ongoing oncological treatment due to other cancer
References
Publications (2)
- DERIVEDLygre 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. PMID 38242575
- DERIVEDLygre 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