The Benefits of R Anastomotic Technique for Billroth-II Reconstruction With Braun Anastomosis During Totally Laparoscopic Distal Gastrectomy: a Propensity Score Matching Analysis

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 Overview

• Status: Completed
• Conditions: the Incidences of Clavien-Dindo Grade II or Higher; Anastomotic Time
• Intervention / Treatment: Procedure: R anastomosis

• Study Type: Observational
• Enrollment (Actual): 246

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225001
      • Northern Jiangsu People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. 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;
2. patients who underwent B-II-B anastomosis during TLDG; and (3) patients who could be followed up postoperatively.

Exclusion Criteria:

(1) 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
R anastomosis	Procedure: R anastomosis; R anastomosis
B-II-B anastomosis	Procedure: R anastomosis; R anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidences of Clavien-Dindo grade II or higher	the incidences of Clavien-Dindo grade II or higher	2010-2022
anastomotic time	anastomotic time	2010-2022

Collaborators and Investigators

• Sponsor: Daorong Wang

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: R vs B-II-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No