RoboticNCT06396845
Assessing the Benefits of Robotic and Laparoscopic Surgery for Mid and Low Rectal Cancer in Patients: The Charlson Comorbidity Index (CCI)
An observational study of Robotic and Laparoscopic, run by Daorong Wang at 1 site in China.
Trial summary
This retrospective study collected participants who underwent robotic or laparoscopic anterior resection for rectal cancer at the North People's Hospital in Jiangsu from January 2019 to January 2023. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Robotic, Laparoscopic, Anterior Resection for Rectal Cancer
- What is being tested?
- robotic surgery and laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 505 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 3 Jan 2024
- Phase
- Observational
- 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 55 to 85 years
- All sexes
- Adult, Older adult
Study population: Participants who underwent robotic or laparoscopic anterior resection for rectal cancer.
Who may be able to join
- The criteria include: (1) pathology of low rectal cancer (within 10 cm from the anal margin); (2) access to comprehensive pathological and computed tomography (CT) data; (3) completeness of clinical data.
Who cannot join
- patients with other malignant tumors besides rectal cancer, benign disease surgery, and emergency surgery.
Trial locations and contacts
1 site in 1 country.
About this study
This retrospective study collected participants who underwent robotic or laparoscopic anterior resection for rectal cancer at the North People's Hospital in Jiangsu from January 2019 to January 2023.
- Conditions
- Robotic, Laparoscopic, Anterior Resection for Rectal Cancer
- Being tested
- robotic surgery, laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic surgeryProcedure or surgery
robotic surgery
laparoscopic surgeryProcedure or surgery
laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| robotic surgery with cci | Not described Receives: Procedure: robotic surgery; Procedure: laparoscopic surgery | |
| laparoscopic surgery with cci | Not described Receives: Procedure: robotic surgery; Procedure: laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative recurrence rate
postoperative recurrence rate
Measured: 2018-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Jan 2019
- Primary completion1 Jan 2022
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RoboticStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daorong Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daorong Wang, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396845
- Sponsor's protocol ID
- CCI1
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Benefits of Robotic and Laparoscopic Surgery for Mid and Low Rectal Cancer in Patients: The Charlson Comorbidity Index (CCI)
- ClinicalTrials.gov ID
- NCT06396845
- Acronym / sponsor ID
- CCI1
- Conditions
- Robotic, Laparoscopic, Anterior Resection for Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Daorong WangUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 2 May 2024 (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.
This retrospective study collected participants who underwent robotic or laparoscopic anterior resection for rectal cancer at the North People's Hospital in Jiangsu from January 2019 to January 2023.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic surgery with cci | – | Procedure: robotic surgery, Procedure: laparoscopic surgery |
| laparoscopic surgery with cci | – | Procedure: robotic surgery, Procedure: laparoscopic surgery |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants who underwent robotic or laparoscopic anterior resection for rectal cancer.
Key inclusion criteria (1 listed)
- The criteria include: (1) pathology of low rectal cancer (within 10 cm from the anal margin); (2) access to comprehensive pathological and computed tomography (CT) data; (3) completeness of clinical data.
Key exclusion criteria (1 listed)
- patients with other malignant tumors besides rectal cancer, benign disease surgery, and emergency surgery.
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 surgeryrobotic surgery | Procedure or surgery | laparoscopic surgery with cci, robotic surgery with cci |
| laparoscopic surgerylaparoscopic surgery | Procedure or surgery | laparoscopic surgery with cci, robotic surgery with cci |
Primary outcome
postoperative recurrence rate
Time frame: 2018-2024
postoperative recurrence rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: No
Related trials for Robotic
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Not yet recruiting
5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies
Lung Cancer
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Recruiting
Development of a Real-time Controller to Estimate Walking Performance Using a Bilateral Ankle Exoskeleton
Healthy Young Adults
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Robotic and Laparoscopic, run by Daorong Wang 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: finished, as of the sponsor's last update on 2 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative recurrence rate (time frame: 2018-2024). 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 2 May 2024.