ObesitySurg_2021NCT04716062
Short-term and Oncological Outcomes of Laparoscopic Colorectal Cancer Surgery in Obese Patients
An observational study of Obesity and Colorectal Cancer, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial summary
A total of 138 consecutive patients who underwent laparoscopic-assisted or open colectomy for colorectal cancer (CRC) were included in the present study. Subjects commonly shared a condition of overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obesity, Colorectal Cancer
- What is being tested?
- Open or Laparoscopic-assisted Colorectal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 138 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 31 Dec 2020
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: 138 overweight or obese subjects. Fifty-one (37%) subjects underwent open-air surgery and 87 (63%) to VL surgery.
Who may be able to join
- Body mass index >25 Kg/m2
- Colorectal cancer (CRC)
Who cannot join
- Current emergency conditions (i.e., perforation and\or occlusion)
- Pregnancy,
- Co-existing peritoneal carcinomatosis
- Contraindications to LS, such as cardiorespiratory comorbidities (CHD, CHF, and other severe CVD)
- Prior transverse resections
Trial locations and contacts
1 site in 1 country.
Italy1 site
National Institute of Gastroenterology IRCCS S. de Bellis
Castellana Grotte, Bari, 70132
About this study
A total of 138 consecutive patients who underwent laparoscopic-assisted or open colectomy for colorectal cancer (CRC) were included in the present study. Subjects commonly shared a condition of overweight or obesity. The investigators aimed to define any difference between the two different groups (open vs laparoscopic-assisted surgery) and a series of outcomes, i.e. hospitalization, Lymph nodes number, Intra-Surgery complications, and Clavien Dindo score.
Read the detailed description
A total of 138 consecutive patients who underwent laparoscopic-assisted or open colectomy for colorectal cancer (CRC) were included in the present study. Intra-Surgery complications, Previous surgery, Readmission Post Intervention, Location of surgery, Duration of Surgery, Re-intervention (yes), Clearance, and CRM were collected. Subjects commonly shared overweight or obesity. The investigators aimed to define any difference between the two different groups (open vs laparoscopic-assisted surgery) and a series of outcomes, i.e. hospitalization, Lymph nodes number, Intra-Surgery complications, and Clavien Dindo score.
- Conditions
- Obesity, Colorectal Cancer
- Being tested
- Open or Laparoscopic-assisted Colorectal surgery
- Medical subject headings
- Obesity, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open or Laparoscopic-assisted Colorectal surgeryProcedure or surgery
Colorectal surgery
| Study group | Role | What they receive |
|---|---|---|
| subjects who underwent open-air surgery | Fifty-one (37%) out of 138 subjects underwent open-air surgery. Receives: Procedure: Open or Laparoscopic-assisted Colorectal surgery | |
| subjects underwent laparoscopic-assisted surgery | A total of 87 (63%) out of 138 subjects underwent laparoscopic-assisted surgery. Receives: Procedure: Open or Laparoscopic-assisted Colorectal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization
days
Measured: baseline
Lymph Nodes number
Lymph Nodes number
Measured: baseline
Clavien Dindo score (post-operative complications)
1 to 5 point
Measured: baseline
Secondary outcomes (3)
Age
years
Measured: Baseline
Body mass index
Kilograms/m2
Measured: Baseline
Lenght of specimen
centimeters
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluigi Giannelli, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716062
- Sponsor's protocol ID
- Surg_2021
- Acronym
- Surg_2021
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term and Oncological Outcomes of Laparoscopic Colorectal Cancer Surgery in Obese Patients
- ClinicalTrials.gov ID
- NCT04716062
- Acronym / sponsor ID
- Surg_2021 / Surg_2021
- Conditions
- Obesity, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Jan 2021 (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.
A total of 138 consecutive patients who underwent laparoscopic-assisted or open colectomy for colorectal cancer (CRC) were included in the present study. Subjects commonly shared a condition of overweight or obesity. The investigators aimed to define any difference between the two different groups (open vs laparoscopic-assisted surgery) and a series of outcomes, i.e. hospitalization, Lymph nodes number, Intra-Surgery complications, and Clavien Dindo score.
Detailed description
A total of 138 consecutive patients who underwent laparoscopic-assisted or open colectomy for colorectal cancer (CRC) were included in the present study. Intra-Surgery complications, Previous surgery, Readmission Post Intervention, Location of surgery, Duration of Surgery, Re-intervention (yes), Clearance, and CRM were collected. Subjects commonly shared overweight or obesity. The investigators aimed to define any difference between the two different groups (open vs laparoscopic-assisted surgery) and a series of outcomes, i.e. hospitalization, Lymph nodes number, Intra-Surgery complications, and Clavien Dindo score.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subjects who underwent open-air surgery | – | Procedure: Open or Laparoscopic-assisted Colorectal surgeryFifty-one (37%) out of 138 subjects underwent open-air surgery. |
| subjects underwent laparoscopic-assisted surgery | – | Procedure: Open or Laparoscopic-assisted Colorectal surgeryA total of 87 (63%) out of 138 subjects underwent laparoscopic-assisted surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 138 overweight or obese subjects. Fifty-one (37%) subjects underwent open-air surgery and 87 (63%) to VL surgery.
Key inclusion criteria (2 listed)
- Body mass index >25 Kg/m2
- Colorectal cancer (CRC)
Key exclusion criteria (5 listed)
- Current emergency conditions (i.e., perforation and\or occlusion)
- Pregnancy,
- Co-existing peritoneal carcinomatosis
- Contraindications to LS, such as cardiorespiratory comorbidities (CHD, CHF, and other severe CVD)
- Prior transverse resections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open or Laparoscopic-assisted Colorectal surgeryColorectal surgery | Procedure or surgery | subjects underwent laparoscopic-assisted surgery, subjects who underwent open-air surgery |
Primary outcome
Hospitalization
Time frame: baseline
days
Lymph Nodes number
Time frame: baseline
Lymph Nodes number
Clavien Dindo score (post-operative complications)
Time frame: baseline
1 to 5 point
3 secondary outcomes
Age
Time frame: Baseline
Body mass index
Time frame: Baseline
Lenght of specimen
Time frame: Baseline
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 20 Jan 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Colorectal Cancer, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
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 2 inclusion and 5 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 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Hospitalization (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2021.