Colorectal CancerLOSCRONCT06221878
Comparison of Laparoscopic and Open Surgery for Colorectal Malignancy in Obese Patients
An observational study of Colorectal Cancer and Obesity, run by Chang Gung Memorial Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Obesity
- How many people
- 473 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- non-adenocarcinoma neoplasms
- Stage IV CRC
About this study
Official title: 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:
- the short-term outcome and postoperative outcomes of patients treated with open group versus laparoscopy group
- the long-term oncologic outcome of patients treated with open group versus laparoscopy group
Read more
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.
Read the 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.
- Conditions
- Colorectal Cancer, Obesity
- Keywords
- Colorectal cancer, obesity, laparoscopy surgery, open surgery, postoperative survival analysis
- Medical subject headings
- Colorectal Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Short-term outcome
Postoperative mortality risk
Measured: 2009 to 2019
Short-term outcome
Postoperative morbidity risk
Measured: 2009 to 2019
Short-term outcome
Clavien-Dindo classification
Measured: 2009 to 2019
Short-term outcome
Length of hospital stay
Measured: 2009 to 2019
Short-term outcome
Incidence of readmission
Measured: 2009 to 2019
Secondary outcomes (3)
Long-term Oncologic outcome
Disease-free survival (DFS)
Measured: 2009 to 2019
Long-term Oncologic outcome
Overall survival (OS)
Measured: 2009 to 2019
Long-term Oncologic outcome
Recurrence rate
Measured: 2009 to 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study startJan 2009
- Primary completion31 Dec 2019
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221878
- Sponsor's protocol ID
- 202301534B0
- Acronym
- LOSCRO
- Status last verified
- Jan 1995
- First submitted
- 12 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data that support the findings of this study are available from the corresponding author upon reasonable request
Publications
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.
PubMed 38833348
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Prognostic Impact of Laparoscopic Surgery in Patients With Systemic Obesity and Colorectal Malignant Tumors
- ClinicalTrials.gov ID
- NCT06221878
- Acronym / sponsor ID
- LOSCRO / 202301534B0
- Conditions
- Colorectal Cancer, Obesity
- Keywords
- Colorectal cancer, obesity, laparoscopy surgery, open surgery, postoperative survival analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- the short-term outcome and postoperative outcomes of patients treated with open group versus laparoscopy group
- 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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- non-adenocarcinoma neoplasms
- Stage IV CRC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short-term outcome
Time frame: 2009 to 2019
Postoperative mortality risk
Short-term outcome
Time frame: 2009 to 2019
Postoperative morbidity risk
Short-term outcome
Time frame: 2009 to 2019
Clavien-Dindo classification
Short-term outcome
Time frame: 2009 to 2019
Length of hospital stay
Short-term outcome
Time frame: 2009 to 2019
Incidence of readmission
3 secondary outcomes
Long-term Oncologic outcome
Time frame: 2009 to 2019
Long-term Oncologic outcome
Time frame: 2009 to 2019
Long-term Oncologic outcome
Time frame: 2009 to 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Derived from this study: PubMed 38833348Hsu 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.
- Individual participant dataSharing planned: Undecided. The data that support the findings of this study are available from the corresponding author upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Obesity, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term outcome (time frame: 2009 to 2019). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06221878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.