NCT06404580

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

3.5 years

First QC Date

May 5, 2024

Last Update Submit

May 5, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

R anastomosis

Procedure: R anastomosis

B-II-B anastomosis

Procedure: R anastomosis

Interventions

R anastomosisPROCEDURE

R anastomosis

B-II-B anastomosisR anastomosis

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

May 5, 2024

First Posted

May 8, 2024

Study Start

March 1, 2019

Primary Completion

September 1, 2022

Study Completion

January 1, 2023

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations