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

Obesity Clinical Trial

— LOSCRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06221878
• Other study ID #: 202301534B0
• Status: Completed
• Start date: January 2009
• Est. completion date: December 31, 2022

Study information

• Verified date: January 1995
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Obesity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term outcome	Postoperative mortality risk	2009 to 2019
Primary	Short-term outcome	Postoperative morbidity risk	2009 to 2019
Primary	Short-term outcome	Clavien-Dindo classification	2009 to 2019
Primary	Short-term outcome	Length of hospital stay	2009 to 2019
Primary	Short-term outcome	Incidence of readmission	2009 to 2019
Secondary	Long-term Oncologic outcome	Disease-free survival (DFS)	2009 to 2019
Secondary	Long-term Oncologic outcome	Overall survival (OS)	2009 to 2019
Secondary	Long-term Oncologic outcome	Recurrence rate	2009 to 2019