Laparoscopic Versus Open Right Colectomy for Right Colon Cancer

NCT05713903 | Recruiting

• 1 other identifier: LORC
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research protocol is to compare open versus laparoscopic right colectomy (according to the CME technique of complete mesocolic excision) for right colon cancer. This study will be designed as a prospective randomized controlled trial. The comparison of the two techniques will include endpoints regarding the quality characteristics of the specimens and the oncological results. In addition, the effectiveness of the two methods will be evaluated in terms of the early and late postoperative period.

Conditions

Colon Cancer

Keywords

colon; cancer; open; laparoscopic; colectomy; right; mesocolic; excision

Outcome Measures

Primary Outcomes (1)

• Mesocolic Resection Plane

  Occurrence of Mesocolic Resection Plane. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  1 month postoperatively

Secondary Outcomes (11)

• Open Conversion

  Intraoperative period

• Operative Time

  Intraoperative period

• Type of Anastomosis

  Intraoperative period

• Intraoperative Transfusion

  Intraoperative period

• Postoperative Complication

  1 month postoperatively

Study Arms (2)

Laparoscopic right colectomy

EXPERIMENTAL

In laparoscopic right colectomy subgroup, the patient will be placed in a lithotomy position. Entrance in the peritoneal cavity will be completed via the open Hasson method. Overall, 4 ports will be used: 10mm at the umbilicus for optical entry, 12mm in the left midclavicular line below the umbilicus as the main working port, 5mm at the McBurney point, and 5mm between the umbilicus and the xiphoid process. Dissection of the peritoneal fold, under the terminal ileum, will be performed based on the medial to lateral approach. Similar to the open approach, the ileocolic vessels, as well as the right branches of the middle colic will be ligated at their origin for cecal and proximal ascending tumors. For hepatic flexure cancers, the medial colic vessels will be ligated. The ileocolic anastomosis will be completed either intracorporeally or extracorporeally, using staples or sutures.

Procedure: Laparoscopic right colectomy

Open right colectomy

ACTIVE COMPARATOR

In the open right colectomy group, the operation will start with a midline incision and dissection based on the lateral to medial approach. The lateral peritoneal fold along Toldt's line will be incised and the ascending colon will be mobilized from the retroperitoneum according to the embryological dissection planes. Dissection will continue until the anterior surface of the superior mesenteric vessels at the third duodenal part. Ileocolic and right colic vessels will be ligated at their origins. For hepatic flexure tumors, the middle colic vessels will be also ligated at their origin. The ileocolic anastomosis will be performed using an automatic stapler. The anastomosis will be completed either with staples or sutures.

Procedure: Open right colectomy

Interventions

Laparoscopic right colectomy PROCEDURE

Resection of the ascending colon via a laparoscopic approach, adhering to the CME principles

Laparoscopic right colectomy

Open right colectomy PROCEDURE

Resection of the ascending colon via an open approach, adhering to the CME principles

Open right colectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed right colon cancer (cecum, ascending colon, hepatic flexure)
• Surgical resection based on the CME principles
• Patient 18 to 90 years old
• American Society of Anesthesiologists score ≤III
• Τ≤3
• Elective operation
• Signed informed consent of the patient

You may not qualify if:

• Non elective operation (hemorrhage, perforation, obstruction)
• Locally advanced disease (T4)
• Distant metastases (Stage IV)
• American Society of Anesthesiologists ≥IV
• Previous laparotomy
• BMI \>35 kg/m2
• Active sepsis or systemic infection
• Untreated physical and mental disability
• Pregnancy or breast-feeding
• Lack of compliance with the protocol process
• Non-granting of signed informed consent

Sponsors & Collaborators

• Larissa University Hospital: lead

Study Sites (1)

Department of Surgery, University Hospital of Larissa

Larissa, 41110, Greece

RECRUITING

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MeSH Terms

Conditions

Colonic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Konstantinos Perivoliotis, MD

  University Hospital of Larissa

  PRINCIPAL INVESTIGATOR

• George Tzovaras, Prof

  University Hospital of Larissa

  STUDY CHAIR

• Ioannis Baloyiannis, Prof

  University Hospital of Larissa

  STUDY DIRECTOR

Central Study Contacts

Konstantinos Perivoliotis, MD

CONTACT

2413501000; kperi19@gmail.com

George Tzovaras, Prof

CONTACT

2413502804; gtzovaras@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There will be no blindness at the level of the patient, the treating physicians (surgeon, anesthesiologist) and the researcher who will record the data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Perivoliotis Konstantinos, Principal Investigator

Model Details: The study will employ a prospective, parallel randomized-controlled design

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: February 6, 2023
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): January 10, 2028
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)