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

Sponsor

Northern Jiangsu Province People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05826106

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Time for R Anastomosis; Complication Related to Anastomosis	Procedure: R 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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

85 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

R Anastomosis for B-Ⅱ-B Anastomosis

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Sep 1, 2022

Actual Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Complication [6 months]
Anastomotic leakage;Anastomotic site bleeding;Anastomotic stenosis;Gastric emptying dysfunction

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu	China	225001

Sponsors and Collaborators

Northern Jiangsu Province People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiajie Zhou, DR, Northern Jiangsu Province People's Hospital

ClinicalTrials.gov Identifier:

NCT05826106

Other Study ID Numbers:

NorthernJiangsuhospital

First Posted:

Apr 24, 2023

Last Update Posted:

Apr 24, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 24, 2023