Laparoscopic Versus Open Right Colectomy for Right Colon Cancer
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ClinicalTrials.gov Identifier: NCT05713903 |
Recruitment Status :
Recruiting
First Posted : February 6, 2023
Last Update Posted : March 13, 2024
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Condition or disease | Intervention/treatment | Phase |
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Colon Cancer | Procedure: Laparoscopic right colectomy Procedure: Open right colectomy | Not Applicable |
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 |
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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.
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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.
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Procedure: Open right colectomy
Resection of the ascending colon via an open approach, adhering to the CME principles |
- 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'
- 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'
- Operative Time [ Time Frame: Intraoperative period ]The total operative time will be recorded. Measurement unit: minutes
- 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'
- 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'
- 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'
- Bowel Function Recovery [ Time Frame: 7 days postoperatively ]Postoperative time until the recovery of bowel function is achieved. Measurement unit: days
- 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
- 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'
- 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'
- 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'
- 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'
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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
Contact: Konstantinos Perivoliotis, MD | 2413501000 ext 0030 | kperi19@gmail.com | |
Contact: George Tzovaras, Prof | 2413502804 ext 0030 | gtzovaras@hotmail.com |
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 |
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 |
Documents provided by Perivoliotis Konstantinos, Larissa University Hospital:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
colon cancer open laparoscopic |
colectomy right mesocolic excision |
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |