NCT06221878

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
473

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2009

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 12, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 1995

Enrollment Period

11 years

First QC Date

January 12, 2024

Last Update Submit

January 23, 2024

Conditions

Keywords

Colorectal cancerobesitylaparoscopy surgeryopen surgerypostoperative survival analysis

Outcome Measures

Primary Outcomes (5)

  • Short-term outcome

    Postoperative mortality risk

    2009 to 2019

  • Short-term outcome

    Postoperative morbidity risk

    2009 to 2019

  • Short-term outcome

    Clavien-Dindo classification

    2009 to 2019

  • Short-term outcome

    Length of hospital stay

    2009 to 2019

  • Short-term outcome

    Incidence of readmission

    2009 to 2019

Secondary Outcomes (3)

  • Long-term Oncologic outcome

    2009 to 2019

  • Long-term Oncologic outcome

    2009 to 2019

  • Long-term Oncologic outcome

    2009 to 2019

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • non-adenocarcinoma neoplasms
  • Stage IV CRC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Colorectal NeoplasmsObesity

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2024

First Posted

January 24, 2024

Study Start

January 1, 2009

Primary Completion

December 31, 2019

Study Completion

December 31, 2022

Last Updated

January 24, 2024

Record last verified: 1995-01