Complications, Neoplasms Recurrence, Operation Finding, Pathology, Quality of Life
Conditions
Brief summary
Laparoscopic complete mesocolic excision is a concept that using laparoscopic surgery technique to perform a resection for colon cancer. Besides, the segment of the colon containing the tumor, the resection area should include an intact mesocolon as an envelope to encase the possible route for metastasis. The routes include blood vessels, lymphatic drain and etc. Such hypothesis predicts better histopathological and higher oncological results which turns into better survival rate and better quality of life.
Interventions
laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized.
PROCEDURED3-laparoscopic colectomy
D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.
Sponsors
Bo Feng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patients with pathologically confirmed colon cancer * Signed consent
Exclusion criteria
* History of malignancy * Intestinal obstruction or perforation * Evidence of metastasis by preoperative examinations * Deformity of spine * Emergency case * BMI \> 29
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histopathological Outcomes Obtained Through the Surgeries | 14 days after the surgery | number of lymph nodes retrieved |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival Rate | 3 years after the surgery | The follow up to the patients after the surgery to evaluate the oncological results of the technique |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laparoscopic Complete Mesocolic Excision Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision
laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized. | 49 |
| D3 Laparoscopic Colectomy Randomized group of patients receiving laparoscopic colectomy with D3-resection
D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. | 50 |
| Total | 99 |
Baseline characteristics
| Characteristic | Laparoscopic Complete Mesocolic Excision | D3 Laparoscopic Colectomy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 29 Participants | 28 Participants | 57 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 22 Participants | 42 Participants |
| Region of Enrollment China | 49 participants | 50 participants | 99 participants |
| Sex: Female, Male Female | 26 Participants | 24 Participants | 50 Participants |
| Sex: Female, Male Male | 23 Participants | 26 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 50 |
| serious Total, serious adverse events | 12 / 49 | 19 / 50 |
Outcome results
Primary
Histopathological Outcomes Obtained Through the Surgeries
number of lymph nodes retrieved
Time frame: 14 days after the surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Complete Mesocolic Excision | Histopathological Outcomes Obtained Through the Surgeries | 20.3 nodes | Standard Deviation 5.8 |
| D3 Laparoscopic Colectomy | Histopathological Outcomes Obtained Through the Surgeries | 19.2 nodes | Standard Deviation 6.7 |
Secondary
Survival Rate
The follow up to the patients after the surgery to evaluate the oncological results of the technique
Time frame: 3 years after the surgery