Comparison of Laparoscopic and Open Surgery for Colorectal Malignancy in Obese Patients (LOSCRO)

January 23, 2024 updated by: Chang Gung Memorial Hospital

Analysis of the Prognostic Impact of Laparoscopic Surgery in Patients With Systemic Obesity and Colorectal Malignant Tumors

The goal of this observational study is to compare laparoscopic and open surgery outcomes in colorectal cancer patients with BMI ≥ 30 kg/m2 . The main question[s] it aims to answer are:

  1. the short-term outcome and postoperative outcomes of patients treated with open group versus laparoscopy group
  2. the long-term oncologic outcome of patients treated with open group versus laparoscopy group

This study is a retrospective and observational study. Subjects were not be given or offered any treatment during the study. The investigator reviewed the patient's medical history and examination report to determine eligibility based on inclusion and exclusion criteria.

If there is a comparison group: Researchers compared the open group and laparoscopy group to see if the laparoscopic group have better short-term outcomes with comparable oncologic outcomes to the open group.

Study Overview

Status

Completed

Conditions

Detailed Description

This study is a retrospective and observational study. Subjects were not be given or offered any treatment during the study. The investigator reviewed the patient's medical history and examination report to determine eligibility based on inclusion and exclusion criteria.

Given the uncertainty regarding the long-term outcomes of laparoscopy in obese patients with CRC, this study aimed to analyse a decade of data comparing laparoscopic and open surgery outcomes in patients with BMI ≥ 30 kg/m2 who had undergone treatment for CRC at the Linkou Chang Gung Hospital.

Study Type

Observational

Enrollment (Actual)

473

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

Stage I ~ III Colorectal adenocarcinoma patients with BMI ≥ 30 kg/m2 who underwent colorectal surgery at the Linkou branch of the Chang Gung Memorial Hospital (CGMH) between January 2009 and December 2019.

Description

Inclusion Criteria:

  • CRC patients with BMI ≥ 30 kg/m2 who underwent colorectal surgery at the Linkou branch of the Chang Gung Memorial Hospital (CGMH) between January 2009 and December 2019.

Exclusion Criteria:

  • non-adenocarcinoma neoplasms
  • Stage IV CRC

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
Laparoscopic Group
Individuals with a body mass index of ≥ 30 kg/m2 underwent laparoscopic surgery for primary stage I-III colorectal adenocarcinoma.
Open Group
Individuals with a body mass index of ≥ 30 kg/m2 underwent open surgery for primary stage I-III colorectal adenocarcinoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term outcome
Time Frame: 2009 to 2019
Postoperative mortality risk
2009 to 2019
Short-term outcome
Time Frame: 2009 to 2019
Postoperative morbidity risk
2009 to 2019
Short-term outcome
Time Frame: 2009 to 2019
Clavien-Dindo classification
2009 to 2019
Short-term outcome
Time Frame: 2009 to 2019
Length of hospital stay
2009 to 2019
Short-term outcome
Time Frame: 2009 to 2019
Incidence of readmission
2009 to 2019

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term Oncologic outcome
Time Frame: 2009 to 2019
Disease-free survival (DFS)
2009 to 2019
Long-term Oncologic outcome
Time Frame: 2009 to 2019
Overall survival (OS)
2009 to 2019
Long-term Oncologic outcome
Time Frame: 2009 to 2019
Recurrence rate
2009 to 2019

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial 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)

January 1, 2009

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 1995

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202301534B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data that support the findings of this study are available from the corresponding author upon reasonable request

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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