Colon CancerRALHNCT03696472
Robotic-assisted Left Hemicolectomy for Left Colon Cancer
A study testing robotic assisted surgery and laparoscopic in people with Colon Cancer, run by Southwest Hospital, China at 1 site in China.
Trial summary
The main goal of this study is to clarify if Robotic-assisted surgery could become the standard approach in patients undergoing left colonic resection. Patient candidates to left colonic resection were randomly assigned to Robotic(RAL) or laparoscopic(LL) approach. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- robotic assisted surgery and laparoscopic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- Dec 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Colon cancer adenocarcinoma The tumor located between the descending colon and the right 1/3 of transverse colon Tumors T3,Т4а,b N0-2 Tolerance of chemotherapy ECOG 0-2
Who cannot join
- With distant metastases Tumors T1-2 Complications of tumor Women during Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
Southwest Hospital
Chongqing, 400038
Yu Peiwu, M.D/Ph.D, +862368754167, yupeiwu1961@aliyun.com
About this study
Official title: Robotic-assisted Left Hemicolectomy for Left Colon Cancer With a Medial-to-lateral Approach Orientated by AMA or AMV
The main goal of this study is to clarify if Robotic-assisted surgery could become the standard approach in patients undergoing left colonic resection.
Patient candidates to left colonic resection were randomly assigned to Robotic(RAL) or laparoscopic(LL) approach. The surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital days. Long-term morbidity, quality of life, and 5-year survival have also been evaluated
Read the detailed description
Robotic-assisted Left Hemicolectomy as advantages on showing the inferior mesenteric artery (IMA), protection of autonomic nerve compare to laparoscopic approach. Our experience found that operational flexibility was advantage without surgeon's position exchange.
- Conditions
- Colon Cancer
- Being tested
- robotic assisted surgery, laparoscopic
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic assisted surgeryProcedure or surgery
robotic assisted surgery was benefit to operation
laparoscopicProcedure or surgery
conventional laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| robotic-assisted left colonic resection | Experimental | Standard left colonic resection assisted by Davinci Robotic Receives: Procedure: robotic assisted surgery |
| laparoscopic left colonic resection | Active comparator | Standard laparoscopic left colonic resection Receives: Procedure: laparoscopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-years overall survival rate
Measured: 5 years
Secondary outcomes (7)
Short-term morbidity rate
Measured: 30 days
Anastomosis leakage rate
Measured: 6 months
Operation Time
Measured: 1 day
Blood loss during operation
Measured: 1 day
Complication incident rate of surgery
Measured: 1 day
C-reaction protein level
Measured: 7 days
Recovery time after surgery
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study startDec 2018 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Chuan, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696472
- Sponsor's protocol ID
- RoboticALH
- Acronym
- RALH
- Status last verified
- Oct 2018
- First submitted
- 24 Apr 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-assisted Left Hemicolectomy for Left Colon Cancer With a Medial-to-lateral Approach Orientated by AMA or AMV
- ClinicalTrials.gov ID
- NCT03696472
- Acronym / sponsor ID
- RALH / RoboticALH
- Conditions
- Colon Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this study is to clarify if Robotic-assisted surgery could become the standard approach in patients undergoing left colonic resection.
Patient candidates to left colonic resection were randomly assigned to Robotic(RAL) or laparoscopic(LL) approach. The surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital days. Long-term morbidity, quality of life, and 5-year survival have also been evaluated
Detailed description
Robotic-assisted Left Hemicolectomy as advantages on showing the inferior mesenteric artery (IMA), protection of autonomic nerve compare to laparoscopic approach. Our experience found that operational flexibility was advantage without surgeon's position exchange.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic-assisted left colonic resection | Experimental | Procedure: robotic assisted surgeryStandard left colonic resection assisted by Davinci Robotic |
| laparoscopic left colonic resection | Active comparator | Procedure: laparoscopicStandard laparoscopic left colonic resection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Colon cancer adenocarcinoma The tumor located between the descending colon and the right 1/3 of transverse colon Tumors T3,Т4а,b N0-2 Tolerance of chemotherapy ECOG 0-2
Key exclusion criteria (1 listed)
- With distant metastases Tumors T1-2 Complications of tumor Women during Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robotic assisted surgeryrobotic assisted surgery was benefit to operation | Procedure or surgery | robotic-assisted left colonic resection |
| laparoscopicconventional laparoscopic surgery | Procedure or surgery | laparoscopic left colonic resection |
Primary outcome
5-years overall survival rate
Time frame: 5 years
7 secondary outcomes
Short-term morbidity rate
Time frame: 30 days
Anastomosis leakage rate
Time frame: 6 months
Operation Time
Time frame: 1 day
Blood loss during operation
Time frame: 1 day
Complication incident rate of surgery
Time frame: 1 day
C-reaction protein level
Time frame: 7 days
Recovery time after surgery
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic assisted surgery and laparoscopic in people with Colon Cancer, run by Southwest Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Chuan, M.D (+862368754167, lee_tran@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-years overall survival rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018; AzTrials last refreshed its copy on 6 Nov 2026.