Rectal CancerNCT06396975
Comparison of Short-term Outcomes of Robotic and Laparoscopic Surgery in Patients With Different Body Mass Index for Mid and Low Rectal Cancer
An observational study of Rectal Cancer, run by Daorong Wang at 1 site in China.
Trial summary
Numerous comparison studies on the outcomes of robotic and laparoscopic surgery in the treatment of rectal cancer have been undertaken and reported. But there aren't many studies that compare the safety and effectiveness of the two surgery procedures used to treat people with mid and low rectal cancer who have… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- robotic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,413 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 29 Apr 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: The clinical records of patients who had laparoscopic or robotic proctectomy at Northern Jiangsu People's Hospital between December 2019 and August 2023 were analyzed in order to conduct research utilizing a retrospective research technique.
Who may be able to join
- The inclusion decision was made based on the following criteria: the results of the preoperative evaluation revealed the existence of adenocarcinoma in the middle to lower rectum (less than 10 centimeters distant from the anal edge); received a drastic operation that might have been laparoscopic or robotic and was based on the principle of TME; distant metastases that are non-conformist or heteroclinic, and there are no additional malignant tumors present at the same time as the operation.
Who cannot join
- a high tumor location that was more than 10 centimeters away from the anal margin; surgery was unsuccessful in completing anal preservation due to invasion of the external anal sphincter; cancerous obstruction or perforation; severe cardiopulmonary dysfunction classified as stage IV according to the ASA score; and poor preoperative anal function; any resection that is performed in combination, rather than being a R0 resection.
Trial locations and contacts
1 site in 1 country.
About this study
Numerous comparison studies on the outcomes of robotic and laparoscopic surgery in the treatment of rectal cancer have been undertaken and reported. But there aren't many studies that compare the safety and effectiveness of the two surgery procedures used to treat people with mid and low rectal cancer who have different body mass indexes (BMIs). This study was done to organize the clinical data we had at our hospital so we could compare the perioperative effectiveness of two minimally invasive approaches for people with different BMIs.
- Conditions
- Rectal Cancer
- Being tested
- robotic surgery
- Medical subject headings
- 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 | Not described Receives: Procedure: robotic surgery | |
| robotic surgery | Not described Receives: Procedure: robotic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncological outcomes
Oncological outcomes
Measured: 2019-2023
the frequency of complications
the frequency of complications
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 Jan 2019
- Primary completion29 Apr 2023
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 1,413 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
- NCT06396975
- Sponsor's protocol ID
- Northjiangsu020
- 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 Short-term Outcomes of Robotic and Laparoscopic Surgery in Patients With Different Body Mass Index for Mid and Low Rectal Cancer
- ClinicalTrials.gov ID
- NCT06396975
- Acronym / sponsor ID
- Northjiangsu020
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,413 participants (actual)
- Lead sponsor
- Daorong WangUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 29 Apr 2023 (actual)
- Study completion
- 29 Apr 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.
Numerous comparison studies on the outcomes of robotic and laparoscopic surgery in the treatment of rectal cancer have been undertaken and reported. But there aren't many studies that compare the safety and effectiveness of the two surgery procedures used to treat people with mid and low rectal cancer who have different body mass indexes (BMIs). This study was done to organize the clinical data we had at our hospital so we could compare the perioperative effectiveness of two minimally invasive approaches for people with different BMIs.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic surgery | – | Procedure: robotic surgery |
| robotic surgery | – | Procedure: robotic surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The clinical records of patients who had laparoscopic or robotic proctectomy at Northern Jiangsu People's Hospital between December 2019 and August 2023 were analyzed in order to conduct research utilizing a retrospective research technique.
Key inclusion criteria (1 listed)
- The inclusion decision was made based on the following criteria: the results of the preoperative evaluation revealed the existence of adenocarcinoma in the middle to lower rectum (less than 10 centimeters distant from the anal edge); received a drastic operation that might have been laparoscopic or robotic and was based on the principle of TME; distant metastases that are non-conformist or heteroclinic, and there are no additional malignant tumors present at the same time as the operation.
Key exclusion criteria (1 listed)
- a high tumor location that was more than 10 centimeters away from the anal margin; surgery was unsuccessful in completing anal preservation due to invasion of the external anal sphincter; cancerous obstruction or perforation; severe cardiopulmonary dysfunction classified as stage IV according to the ASA score; and poor preoperative anal function; any resection that is performed in combination, rather than being a R0 resection.
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, robotic surgery |
Primary outcome
Oncological outcomes
Time frame: 2019-2023
Oncological outcomes
the frequency of complications
Time frame: 2019-2023
the frequency of complications
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 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?
Oncological outcomes (time frame: 2019-2023). The study lists 2 primary outcomes in all. 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.