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

NCT ID: NCT06221878

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

473 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Laparoscopic Group

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

No interventions assigned to this group

Open Group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Hsu YJ, Yu YL, Jhuang JR, You JF, Liao CK, Tsai WS, Pan YP, Chern YJ. Comparison of laparoscopic and open surgery for colorectal malignancy in obese patients: a propensity score-weighted cohort study. Int J Surg. 2024 Aug 1;110(8):4598-4607. doi: 10.1097/JS9.0000000000001536.

Reference Type DERIVED
PMID: 38833348 (View on PubMed)

Other Identifiers

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202301534B0

Identifier Type: -

Identifier Source: org_study_id

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