the Incidences of Clavien-Dindo Grade II or HigherNCT06404580
The Benefits of R Anastomotic Technique for Billroth-II Reconstruction With Braun Anastomosis During Totally Laparoscopic Distal Gastrectomy: a Propensity Score Matching Analysis
An observational study of the Incidences of Clavien-Dindo Grade II or Higher and Anastomotic Time, run by Daorong Wang at 1 site in China.
Trial summary
Between March 2019 and September 2022 in our centre, R anastomosis was performed on 123 patients undergoing TLDG for distal gastric cancer. A retrospective review of a prospectively collected database identified patients who underwent TLDG between January 2010 and September 2022. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- the Incidences of Clavien-Dindo Grade II or Higher, Anastomotic Time
- What is being tested?
- R anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 246 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 1 Jan 2023
- 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 35 to 80 years
- All sexes
- Adult, Older adult
Study population: between March 2019 and September 2022 at Northern Jiangsu people's hospital were prospectively collected, and data from patients who underwent conventional anastomosis (control group) were retrospectively collected from the same prospectively maintained database of patients who underwent TLDG between January 2010 and February 2019 at Northern Jiangsu people's hospital.
Who may be able to join
- elective surgery for endoscopic and pathological diagnosis of malignant tumour of the gastric antrum or body with no distant metastases confirmed by multilayer spiral computed tomography;
- patients who underwent B-II-B anastomosis during TLDG; and (3) patients who could be followed up postoperatively.
Who cannot join
- patients who had received preoperative neoadjuvant radiotherapy or chemotherapy; (2) patients undergoing emergency surgery; (3) the presence of other malignant tumours concurrently; and (4) patients who were lost to follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Between March 2019 and September 2022 in our centre, R anastomosis was performed on 123 patients undergoing TLDG for distal gastric cancer. A retrospective review of a prospectively collected database identified patients who underwent TLDG between January 2010 and September 2022. Patients who underwent R anastomosis were matched in a 1:1 ratio with patients who underwent conventional anastomosis using a propensity score based on age, sex, preoperative BMI, American Society of Anesthesiologists (ASA) score, and the history of abdominal surgery. Surgical and postoperative outcomes and clinicopathological data were analyzed for both groups.
- Being tested
- R anastomosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R anastomosisProcedure or surgery
R anastomosis
| Study group | Role | What they receive |
|---|---|---|
| R anastomosis | Not described Receives: Procedure: R anastomosis | |
| B-II-B anastomosis | Not described Receives: Procedure: R anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidences of Clavien-Dindo grade II or higher
the incidences of Clavien-Dindo grade II or higher
Measured: 2010-2022
anastomotic time
anastomotic time
Measured: 2010-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Mar 2019
- Primary completion1 Sep 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Incidences of Clavien-Dindo Grade II or HigherStudies 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
- 246 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
- NCT06404580
- Sponsor's protocol ID
- R vs B-II-B
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 8 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of R Anastomotic Technique for Billroth-II Reconstruction With Braun Anastomosis During Totally Laparoscopic Distal Gastrectomy: a Propensity Score Matching Analysis
- ClinicalTrials.gov ID
- NCT06404580
- Acronym / sponsor ID
- R vs B-II-B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Daorong WangUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 8 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.
Between March 2019 and September 2022 in our centre, R anastomosis was performed on 123 patients undergoing TLDG for distal gastric cancer. A retrospective review of a prospectively collected database identified patients who underwent TLDG between January 2010 and September 2022. Patients who underwent R anastomosis were matched in a 1:1 ratio with patients who underwent conventional anastomosis using a propensity score based on age, sex, preoperative BMI, American Society of Anesthesiologists (ASA) score, and the history of abdominal surgery. Surgical and postoperative outcomes and clinicopathological data were analyzed for both groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R anastomosis | – | Procedure: R anastomosis |
| B-II-B anastomosis | – | Procedure: R anastomosis |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- between March 2019 and September 2022 at Northern Jiangsu people's hospital were prospectively collected, and data from patients who underwent conventional anastomosis (control group) were retrospectively collected from the same prospectively maintained database of patients who underwent TLDG between January 2010 and February 2019 at Northern Jiangsu people's hospital.
Key inclusion criteria (2 listed)
- elective surgery for endoscopic and pathological diagnosis of malignant tumour of the gastric antrum or body with no distant metastases confirmed by multilayer spiral computed tomography;
- patients who underwent B-II-B anastomosis during TLDG; and (3) patients who could be followed up postoperatively.
Key exclusion criteria (1 listed)
- patients who had received preoperative neoadjuvant radiotherapy or chemotherapy; (2) patients undergoing emergency surgery; (3) the presence of other malignant tumours concurrently; and (4) patients who were lost to follow-up.
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 |
|---|---|---|
| R anastomosisR anastomosis | Procedure or surgery | B-II-B anastomosis, R anastomosis |
Primary outcome
the incidences of Clavien-Dindo grade II or higher
Time frame: 2010-2022
the incidences of Clavien-Dindo grade II or higher
anastomotic time
Time frame: 2010-2022
anastomotic time
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 8 May 2024.
- Individual participant dataSharing planned: No
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 the Incidences of Clavien-Dindo Grade II or Higher and Anastomotic Time, 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 2 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 8 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?
the incidences of Clavien-Dindo grade II or higher (time frame: 2010-2022). 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 8 May 2024.