The Benefits of R Anastomotic Technique for Billroth-Ⅱ Reconstruction With Braun Anastomosis After Totally Laparoscopic Distal Gastrectomy
R Anastomosis for B-Ⅱ-B Anastomosis
1 other identifier
observational
85
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 11, 2023
CompletedFirst Posted
Study publicly available on registry
April 24, 2023
CompletedApril 24, 2023
April 1, 2023
3.5 years
April 11, 2023
April 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Complication
Anastomotic leakage;Anastomotic site bleeding;Anastomotic stenosis;Gastric emptying dysfunction
6 months
Study Arms (1)
R anastomosis
Interventions
Modifying the surgical technique of totally laparoscopic Billroth-II reconstruction with Braun anastomosis and to name it as the R anastomosis.
Eligibility Criteria
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.
You may qualify if:
- (1) 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.
You may not qualify if:
- (1) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DR
Study Record Dates
First Submitted
April 11, 2023
First Posted
April 24, 2023
Study Start
March 1, 2019
Primary Completion
September 1, 2022
Study Completion
March 1, 2023
Last Updated
April 24, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share