Time for R Anastomosis; Complication Related to AnastomosisNCT05826106
The Benefits of R Anastomotic Technique for Billroth-Ⅱ Reconstruction With Braun Anastomosis After Totally Laparoscopic Distal Gastrectomy
An observational study of Time for R Anastomosis; Complication Related to Anastomosis, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
This study proposes a novel, straightforward, and viable technique for performing posterior gastrojejunostomy anastomosis during totally laparoscopic Billroth-II reconstruction with Braun anastomosis (named R anastomosis). Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Time for R Anastomosis; Complication Related to Anastomosis
- What is being tested?
- R anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 1 Mar 2023
- How long will I take part?
- 6 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All cases were confirmed to have malignant tumors in the gastric antrum or body through endoscopic and pathological examinations, and multi-slice spiral CT scans revealed no distant metastasis.
Who may be able to join
- Elective surgery, indications for surgery: Cases diagnosed with malignant tumors of the gastric antrum or body by endoscopy and pathology, confirmed by multi-slice spiral CT to have no distant metastasis. (2) Patients who underwent laparoscopic distal gastrectomy with Billroth II + Braun anastomosis for gastric cancer, and can be followed up after surgery.
Who cannot join
- Patients who received neoadjuvant chemotherapy before surgery; (2) Emergency surgery patients; (3) Patients with concurrent malignant tumors; (4) Patients lost to follow-up due to non-tumor reasons after surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: R Anastomosis for B-Ⅱ-B Anastomosis
This study proposes a novel, straightforward, and viable technique for performing posterior gastrojejunostomy anastomosis during totally laparoscopic Billroth-II reconstruction with Braun anastomosis (named R anastomosis). This study prospectively evaluated clinical and pathological data from patients who underwent totally laparoscopic distal gastrectomy with R anastomosis at Northern Jiangsu People's Hospital, China, in order to investigate the feasibility and functional outcomes of R anastomosis for B-II-B anastomosis.
Read the detailed description
Paients were recruited who were confirmed to have malignant tumors in the gastric antrum or body through endoscopic and pathological examinations, and multi-slice spiral CT scans revealed no distant metastasis. All case underwent totally laparoscopic distal gastrectomy with R anastomosis. Prospectively examined the intraoperative data, including operation time, time for R anastomosis, blood loss; Postoperative data including pathological data, duration of gastric tube placement, time to initiate liquid diet, the length of hospital stay; other functional outcomes and short-term postoperative complication data, graded according to the Clavien-Dindo complication classification system
- 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
Modifying the surgical technique of totally laparoscopic Billroth-II reconstruction with Braun anastomosis and to name it as the R anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| R anastomosis | Not described Receives: Procedure: R anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication
Anastomotic leakage;Anastomotic site bleeding;Anastomotic stenosis;Gastric emptying dysfunction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Mar 2019
- Primary completion1 Sep 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time for R Anastomosis; Complication Related to AnastomosisStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiajie Zhou, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826106
- Sponsor's protocol ID
- NorthernJiangsuhospital
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 24 Apr 2023
- 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 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- R Anastomosis for B-Ⅱ-B Anastomosis
- ClinicalTrials.gov ID
- NCT05826106
- Acronym / sponsor ID
- NorthernJiangsuhospital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 24 Apr 2023 (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 study proposes a novel, straightforward, and viable technique for performing posterior gastrojejunostomy anastomosis during totally laparoscopic Billroth-II reconstruction with Braun anastomosis (named R anastomosis). This study prospectively evaluated clinical and pathological data from patients who underwent totally laparoscopic distal gastrectomy with R anastomosis at Northern Jiangsu People's Hospital, China, in order to investigate the feasibility and functional outcomes of R anastomosis for B-II-B anastomosis.
Detailed description
Paients were recruited who were confirmed to have malignant tumors in the gastric antrum or body through endoscopic and pathological examinations, and multi-slice spiral CT scans revealed no distant metastasis. All case underwent totally laparoscopic distal gastrectomy with R anastomosis. Prospectively examined the intraoperative data, including operation time, time for R anastomosis, blood loss; Postoperative data including pathological data, duration of gastric tube placement, time to initiate liquid diet, the length of hospital stay; other functional outcomes and short-term postoperative complication data, graded according to the Clavien-Dindo complication classification system
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R anastomosis | – | Procedure: R anastomosis |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cases were confirmed to have malignant tumors in the gastric antrum or body through endoscopic and pathological examinations, and multi-slice spiral CT scans revealed no distant metastasis.
Key inclusion criteria (1 listed)
- Elective surgery, indications for surgery: Cases diagnosed with malignant tumors of the gastric antrum or body by endoscopy and pathology, confirmed by multi-slice spiral CT to have no distant metastasis. (2) Patients who underwent laparoscopic distal gastrectomy with Billroth II + Braun anastomosis for gastric cancer, and can be followed up after surgery.
Key exclusion criteria (1 listed)
- Patients who received neoadjuvant chemotherapy before surgery; (2) Emergency surgery patients; (3) Patients with concurrent malignant tumors; (4) Patients lost to follow-up due to non-tumor reasons after 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 |
|---|---|---|
| R anastomosisModifying the surgical technique of totally laparoscopic Billroth-II reconstruction with Braun anastomosis and to name it as the R anastomosis. | Procedure or surgery | R anastomosis |
Primary outcome
Complication
Time frame: 6 months
Anastomotic leakage;Anastomotic site bleeding;Anastomotic stenosis;Gastric emptying dysfunction
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 24 Apr 2023.
- 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 Time for R Anastomosis; Complication Related to Anastomosis, run by Northern Jiangsu People's Hospital 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 24 Apr 2023. 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?
Complication (time frame: 6 months). 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 24 Apr 2023.