Trial Title:
Laparoscopic Versus Open Right Colectomy for Right Colon Cancer
NCT ID:
NCT05713903
Condition:
Colon Cancer
Conditions: Official terms:
Colonic Neoplasms
Conditions: Keywords:
colon
cancer
open
laparoscopic
colectomy
right
mesocolic
excision
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The study will employ a prospective, parallel randomized-controlled design
Primary purpose:
Treatment
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.
Intervention:
Intervention type:
Procedure
Intervention name:
Laparoscopic right colectomy
Description:
Resection of the ascending colon via a laparoscopic approach, adhering to the CME
principles
Arm group label:
Laparoscopic right colectomy
Intervention type:
Procedure
Intervention name:
Open right colectomy
Description:
Resection of the ascending colon via an open approach, adhering to the CME principles
Arm group label:
Open right colectomy
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.
Detailed description:
Colorectal cancer is the third and second most common malignancy in male and female
patients, respectively, with up to 1.8 million new cases and 860,000 deaths per year.
Anterior resection with total mesorectal excision (TME) was first proposed by Heald in
1982 and is currently the gold standard surgical technique for middle and lower rectal
cancer. Heald considered that the metastatic spread of the tumor occurs through
micro-implantations in the lymph node network of the mesorectum, and much less through
horizontal intramural infiltration, and thus defined rectal resection margins at 5cm or
even 2cm for well-differentiated neoplasms. Therefore, he suggested that mesorectum
displays a greater risk for micro-metastatic disease and should be removed en-bloc with
intact resection margins.
Similarly in 2009, Hohenberger proposed the complete mesocolon excision (CME) concept for
the treatment of colon cancer, based on the respective embryological development
anatomical planes. After analyzing a large cohort of patients, he concluded that this
operation type leads to a significant reduction in the local recurrence and an increase
in the overall survival rates.
Hohenberger proposed open CME as the optimal surgical technique for colon cancer, under
the premise that the following principles are met:
- Dissection of Toldt's fascia and mesocolon preservation
- Central vascular ligation
- Extensive locoregional lymph node dissection CME technique, as described by
Hohenberger in 2008, is an extension of Heald's TME and it is based on the sharp
dissection and separation of the visceral fascia that surrounds the colon from the
parietal fascia. The aim is to fully mobilize the colon and the corresponding
mesocolon, which is surrounded bilaterally by sheets of visceral fascia. This
ensures the complete resection of the tumor and the corresponding lymph nodes. At
the same time, central vascular ligation allows the dissection of the apical lymph
nodes.
There are three resection planes: the mesocolic, intramesocolic and muscularis propria
plane. The ideal resection plane is the mesocolic, in which the colon is removed, along
with the entire mesocolon and all the venous and lymphatic tissue, without violating the
visceral fascia. Surgical specimens categorized into either of the other two resection
planes are associated with reduced R0 resection rates and with reduced overall survival.
Characteristically, the muscularis propria resection plane has been associated with up to
15% reduced survival rate compared to the mesocolic plane.
There are specific morphometric characteristics of surgical specimens that are used to
assess their quality. These include tumor and proximal colon high vascular ligation
distance, number of lymph nodes, length of resected small bowel and colon, and total area
of the mesocolon. These characteristics are directly related to the number of harvested
lymph nodes and, therefore, to overall survival.
According to initial results, CME specimens were larger in size, contained a longer
length of colon, a larger mesenteric surface and a greater number of lymph nodes compared
to the standard colectomy specimens. In addition, a greater distance of the tumor from
the resection margins was highlighted. Specifically for right colon cancers, recent
publications have shown that CME can achieve better morphometric specimen characteristics
and a greater number of lymph nodes. In a recent randomized study, Di Buono et al.
compared the completion of CME or not, during laparoscopic right colectomy. A significant
difference was found in favor of CME, regarding the specimen length and the lymph node
harvest.
Despite these, the literature evidence regarding the morphological and qualitative
characteristics of laparoscopic and open CME specimens are still inconclusive.
Specifically for right colectomies, in the comparative study by Gouvas et al., it was
observed that the percentage of the mesocolic resection level was 100% in open colectomy,
in contrast to 85.7% in the laparoscopic approach. However, this difference was not
statistically significant. In a retrospective study by Ali Koc et al., no difference was
found between open and laparoscopic CME in terms of specimen length, R0 resection rate
and number of resected lymph nodes. A recent publication by Ali Zedan et al., argued that
open CME is associated with longer specimens, larger mesenteric area, and increased
resection margins. Another interesting finding was that the number of lymph nodes and the
distance of the ligation site were greater in the laparoscopic CME group. However, the
meta-analysis by Anania et al. failed to validate any difference between the two methods
in the total number of lymph nodes. Finally, a comparative analysis of our own series of
patients did not show superiority of one technique over the other in terms of resection
level, specimen length and number of lymph nodes.
Additional qualitative characteristics of a colon cancer operation include operative
time, intraoperative blood loss, time of bowel function recovery, length of postoperative
hospital stay, postoperative complications, as well as overall survival and local
recurrence rate. In a recent meta-analysis by Anania et al. applying the principles of
CME to right colectomies did not affect the rates of postoperative leaks, bleeding,
overall complications, and reoperations. However, CME right colectomy was associated with
optimal results in terms of 3-year overall survival and 5-year disease-free survival.
Regarding the application of laparoscopy principles to CME colectomies, previous studies
have confirmed that it is a technique with optimal results, such as faster postoperative
recovery, shorter hospital stay, and lower morbidity. There is agreement between studies
regarding the perioperative benefits of laparoscopic CME right colectomy versus the open
method. According to Huang et al., the length of operative time between the two
techniques was comparable. Laparoscopic right colectomy was associated with significantly
lower intraoperative blood loss and faster initiation of feeding. In addition, these
patients were discharged earlier compared to their counterparts in the open colectomy
group. Moreover, no differences were observed in complication and local recurrence rates.
These findings were also confirmed by the comparative study of Sheng et al., where the
application of the minimally invasive technique resulted in lower levels of postoperative
pain, and faster recovery. Accordingly, Shin et al., applying propensity score analysis,
to remove possible confounding factors, in a sample of 2249 right colectomies and found
that the technique is an independent predictor for 5-year disease-free survival. Pooled
data from Anania et al., confirmed the superiority of laparoscopic CME in the rates of
postoperative complications, intraoperative bleeding, and length of hospital stay. These
are also in accordance with our own experience, where a significant benefit of the
laparoscopic approach was shown in the duration of hospitalization and septic
complications, at the cost of prolonged surgical time.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Surgery, University Hospital of Larissa
Address:
City:
Larissa
Zip:
41110
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Konstantinos Perivoliotis, MD
Phone:
00302413501000
Email:
kperi19@gmail.com
Contact backup:
Last name:
George Tzovaras, Professor
Phone:
00302413502804
Email:
gtzovaras@hotmail.com
Investigator:
Last name:
Konstantinos Perivoliotis, MD
Email:
Principal Investigator
Start date:
February 6, 2023
Completion date:
January 10, 2027
Lead sponsor:
Agency:
Larissa University Hospital
Agency class:
Other
Source:
Larissa University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05713903
