The Benefits of R Anastomotic Technique for Billroth-Ⅱ Reconstruction With Braun Anastomosis After Totally Laparoscopic Distal Gastrectomy

April 11, 2023 updated by: Jiajie Zhou, Northern Jiangsu Province People's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

(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.

Exclusion Criteria:

(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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
R anastomosis
Procedure: R anastomosis
Modifying the surgical technique of totally laparoscopic Billroth-II reconstruction with Braun anastomosis and to name it as the R anastomosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication
Time Frame: 6 months
Anastomotic leakage;Anastomotic site bleeding;Anastomotic stenosis;Gastric emptying dysfunction
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Jiangsu Province People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • NorthernJiangsuhospital

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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