Visceral ObesityNCT06397053
Comparison of Robotic Versus Laparoscopic Surgery for Visceral Obesity in Mid-Low Rectal Cancer: A Propensity-Matched Analysis
An observational study of Visceral Obesity and Rectal Cancer, run by Daorong Wang at 1 site in China.
Trial summary
Our team has previously published articles providing detailed descriptions of the steps involved in both RS and LS. All surgeries adhered to the total mesorectal excision (TME) principle. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Visceral Obesity, Rectal Cancer, Robotic Surgery
- What is being tested?
- robotic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 29 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective investigation included participants who experienced anterior rectal resection using robotic or laparoscopic techniques at the General Surgery Department of Northern Jiangsu People's Hospital between December 2019 and October 2023.
Who may be able to join
- confirmed pathology of mid-to-low rectal cancer (within 10 centimeters from the anal margin); (2) availability of comprehensive pathological and computed tomography (CT) data; (3) presence of a diagnosis indicating visceral obesity.
Who cannot join
- Multiple tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Robotic Versus Laparoscopic Surgery for Visceral Obesity in Mid-Low
Our team has previously published articles providing detailed descriptions of the steps involved in both RS and LS. All surgeries adhered to the total mesorectal excision (TME) principle. In RS, a surgeon employed the Da Vinci Xi surgical system featuring a five-port setup, while five physicians conducted LS with a similarly configured five-port approach. Both the RS and LS doctors are experienced. The surgeries were conducted according to standard procedures, and the RS group utilized totally robotic rectal resection.
- Conditions
- Visceral Obesity, Rectal Cancer, Robotic Surgery
- Being tested
- robotic surgery
- Medical subject headings
- Obesity, Abdominal, Rectal Neoplasms
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
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic surgery with visceral obesity | Not described Receives: Procedure: robotic surgery | |
| robotic surgery with visceral obesity | Not described Receives: Procedure: robotic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
early postoperative problems
early postoperative problems
Measured: 2019-2023
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 Dec 2019
- Primary completion30 Oct 2023
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral ObesityStudies 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
- 242 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
- NCT06397053
- Sponsor's protocol ID
- Visceral Obesity001
- 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
- Comparison of Robotic Versus Laparoscopic Surgery for Visceral Obesity in Mid-Low
- ClinicalTrials.gov ID
- NCT06397053
- Acronym / sponsor ID
- Visceral Obesity001
- Conditions
- Visceral Obesity, Rectal Cancer, Robotic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Daorong WangUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 29 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.
Our team has previously published articles providing detailed descriptions of the steps involved in both RS and LS. All surgeries adhered to the total mesorectal excision (TME) principle. In RS, a surgeon employed the Da Vinci Xi surgical system featuring a five-port setup, while five physicians conducted LS with a similarly configured five-port approach. Both the RS and LS doctors are experienced. The surgeries were conducted according to standard procedures, and the RS group utilized totally robotic rectal resection.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic surgery with visceral obesity | – | Procedure: robotic surgery |
| robotic surgery with visceral obesity | – | Procedure: robotic surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective investigation included participants who experienced anterior rectal resection using robotic or laparoscopic techniques at the General Surgery Department of Northern Jiangsu People's Hospital between December 2019 and October 2023.
Key inclusion criteria (1 listed)
- confirmed pathology of mid-to-low rectal cancer (within 10 centimeters from the anal margin); (2) availability of comprehensive pathological and computed tomography (CT) data; (3) presence of a diagnosis indicating visceral obesity.
Key exclusion criteria (1 listed)
- Multiple tumor
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 visceral obesity, robotic surgery with visceral obesity |
Primary outcome
early postoperative problems
Time frame: 2019-2023
early postoperative problems
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
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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.
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 Visceral Obesity and Rectal Cancer, 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?
early postoperative problems (time frame: 2019-2023). 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.