This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Laparoscopic Versus Open Right Colectomy for Right Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05713903
Recruitment Status : Recruiting
First Posted : February 6, 2023
Last Update Posted : March 13, 2024
Sponsor:
Information provided by (Responsible Party):
Perivoliotis Konstantinos, Larissa University Hospital

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Procedure: Laparoscopic right colectomy Procedure: Open right colectomy Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will employ a prospective, parallel randomized-controlled design
Masking: None (Open Label)
Masking Description: There will be no blindness at the level of the patient, the treating physicians (surgeon, anesthesiologist) and the researcher who will record the data.
Primary Purpose: Treatment
Official Title: Comparison of Laparoscopic Versus Open Right Colectomy for Right Colon Cancer, According to the Complete Mesocolic Excision (CME) Principles: a Prospective Randomized Controlled Trial
Actual Study Start Date : February 6, 2023
Estimated Primary Completion Date : January 10, 2026
Estimated Study Completion Date : January 10, 2027

Arm Intervention/treatment
Experimental: Laparoscopic right colectomy
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
Resection of the ascending colon via a laparoscopic approach, adhering to the CME principles

Active Comparator: Open right colectomy
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
Resection of the ascending colon via an open approach, adhering to the CME principles




Primary Outcome Measures :
  1. Mesocolic Resection Plane [ Time Frame: 1 month postoperatively ]
    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'


Secondary Outcome Measures :
  1. Open Conversion [ Time Frame: Intraoperative period ]
    Occurrence of Open Conversion. 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'

  2. Operative Time [ Time Frame: Intraoperative period ]
    The total operative time will be recorded. Measurement unit: minutes

  3. Type of Anastomosis [ Time Frame: Intraoperative period ]
    Occurrence of Stapled or Handsewn Anastomosis. 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'

  4. Intraoperative Transfusion [ Time Frame: Intraoperative period ]
    Occurrence of Intraoperative Transfusion. 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'

  5. Postoperative Complication [ Time Frame: 1 month postoperatively ]
    Occurrence of Postoperative Complication. 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'

  6. Bowel Function Recovery [ Time Frame: 7 days postoperatively ]
    Postoperative time until the recovery of bowel function is achieved. Measurement unit: days

  7. Length of Hospital Stay [ Time Frame: Maximum time frame 39 days postoperatively] ]
    Postoperative time that the patient can be safely discharged. Measurement unit: days. The patient will be discharged, when it is ensured that is medically safe to be released. In particular, as the exit time of the patient, will be regarded the time that the patient will fulfil the Clinical Discharge Criteria

  8. Negative Resection Margin [ Time Frame: 1 month postoperatively ]
    Occurrence of Negative Resection Margin. 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'

  9. Local Recurrence [ Time Frame: 5 years postoperatively ]
    Occurrence of Local Recurrence. 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'

  10. Disease Free Survival [ Time Frame: 5 years postoperatively ]
    Occurrence of Disease Free Survival. 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'

  11. Overall Survival [ Time Frame: 5 years postoperatively ]
    Occurrence of Overall Survival. 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'



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05713903


Contacts
Layout table for location contacts
Contact: Konstantinos Perivoliotis, MD 2413501000 ext 0030 kperi19@gmail.com
Contact: George Tzovaras, Prof 2413502804 ext 0030 gtzovaras@hotmail.com

Locations
Layout table for location information
Greece
Department of Surgery, University Hospital of Larissa Recruiting
Larissa, Greece, 41110
Contact: Konstantinos Perivoliotis, MD    00302413501000    kperi19@gmail.com   
Contact: George Tzovaras, Professor    00302413502804    gtzovaras@hotmail.com   
Principal Investigator: Konstantinos Perivoliotis, MD         
Sponsors and Collaborators
Larissa University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Konstantinos Perivoliotis, MD University Hospital of Larissa
Study Chair: George Tzovaras, Prof University Hospital of Larissa
Study Director: Ioannis Baloyiannis, Prof University Hospital of Larissa
  Study Documents (Full-Text)

Documents provided by Perivoliotis Konstantinos, Larissa University Hospital:
Study Protocol  [PDF] February 9, 2023
Informed Consent Form  [PDF] February 9, 2023

Publications:

Layout table for additonal information
Responsible Party: Perivoliotis Konstantinos, Perivoliotis Konstantinos, Principal Investigator, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT05713903    
Other Study ID Numbers: LORC
First Posted: February 6, 2023    Key Record Dates
Last Update Posted: March 13, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual patient data

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Perivoliotis Konstantinos, Larissa University Hospital:
colon
cancer
open
laparoscopic
colectomy
right
mesocolic
excision
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases