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OpenTrials
Completed

NCT Number: NCT06221878

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

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.

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Key information

Conditions

Colorectal Cancer Body Weight Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Short-term outcome

    Time frame: 2009 to 2019

    Postoperative mortality risk

  2. Short-term outcome

    Time frame: 2009 to 2019

    Postoperative morbidity risk

  3. Short-term outcome

    Time frame: 2009 to 2019

    Clavien-Dindo classification

  4. Short-term outcome

    Time frame: 2009 to 2019

    Length of hospital stay

  5. Short-term outcome

    Time frame: 2009 to 2019

    Incidence of readmission

Secondary outcomes

  1. Long-term Oncologic outcome

    Time frame: 2009 to 2019

    Disease-free survival (DFS)

  2. Long-term Oncologic outcome

    Time frame: 2009 to 2019

    Overall survival (OS)

  3. Long-term Oncologic outcome

    Time frame: 2009 to 2019

    Recurrence rate

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Acronym: LOSCRO

Important dates

Study start
2009
Primary completion
2019
Study completion
2022
First posted
Jan 24, 2024
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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