NCT04834661

Brief Summary

This study investigates the safety and feasibility of performing laparoscopic surgery for colorectal and gastric cancer inside versus outside the primary registered medical institution under multi-sites practice (MSP) policy. This is a single practitioner, retrospective comparative study. The endpoints are peri-operative outcomes, pathological results, and medical costs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,130

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 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

First Submitted

Initial submission to the registry

April 4, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

October 20, 2021

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

11 days

First QC Date

April 4, 2021

Last Update Submit

April 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • overall postoperative complication rate

    postoperative complications evaluated according to Clavin-Dindo classification

    30 days after surgery

Study Arms (2)

inside group

laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution

Other: surgery inside the primary institution

outside group

laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution

Other: surgery outside the primary institution

Interventions

to perform laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution

inside group

to perform laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution

outside group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

colorectal cancer and gastric cancer

You may qualify if:

  • Age between 18 and 100 years
  • diagnosed as colorectal cancer or gastric cancer
  • undergoing laparoscopic surgery between 2016-2020 performed by Dr Feng

You may not qualify if:

  • Emergency procedure
  • without histopathological result of malignancy
  • conventional open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200020, China

Location

MeSH Terms

Conditions

Colorectal NeoplasmsStomach Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesStomach Diseases

Study Officials

  • Zhenghao Cai, MD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending surgeon of gastrointestinal surgery,Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Study Record Dates

First Submitted

April 4, 2021

First Posted

April 8, 2021

Study Start

October 20, 2021

Primary Completion

October 31, 2021

Study Completion

December 31, 2021

Last Updated

April 18, 2022

Record last verified: 2022-04

Locations