Trial Outcomes & Findings for Laparoscopic Complete Mesocolic Excision on Colon Cancer (NCT NCT01628250)
NCT ID: NCT01628250
Last Updated: 2022-11-15
Results Overview
number of lymph nodes retrieved
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
14 days after the surgery
Results posted on
2022-11-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
50
|
|
Overall Study
COMPLETED
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Laparoscopic Complete Mesocolic Excision on Colon Cancer
Baseline characteristics by cohort
| Measure |
Laparoscopic Complete Mesocolic Excision
n=49 Participants
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.
|
D3 Laparoscopic Colectomy
n=50 Participants
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.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
49 participants
n=5 Participants
|
50 participants
n=7 Participants
|
99 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 days after the surgerynumber of lymph nodes retrieved
Outcome measures
| Measure |
Laparoscopic Complete Mesocolic Excision
n=49 Participants
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.
|
D3 Laparoscopic Colectomy
n=50 Participants
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.
|
|---|---|---|
|
Histopathological Outcomes Obtained Through the Surgeries
|
20.3 nodes
Standard Deviation 5.8
|
19.2 nodes
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: 3 years after the surgeryThe follow up to the patients after the surgery to evaluate the oncological results of the technique
Outcome measures
Outcome data not reported
Adverse Events
Laparoscopic Complete Mesocolic Excision
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
D3 Laparoscopic Colectomy
Serious events: 19 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Laparoscopic Complete Mesocolic Excision
n=49 participants at risk
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.
|
D3 Laparoscopic Colectomy
n=50 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
vessel-related complication
|
24.5%
12/49 • Number of events 12
|
38.0%
19/50 • Number of events 19
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Bo Feng
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Phone: 021-64458887
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place