Colorectal DisordersNCT04461054
Which Type of Laparoscopic Colectomy, Right or Left, Have Better Postoperative Outcomes for the Patients?
An observational study of Colorectal Disorders, run by Leonardo Bustamante-Lopez at 1 site in Brazil.
Trial summary
Laparoscopic surgery decreased the morbidity of colorectal surgery. The two most common surgeries for colorectal cancer are right and left colectomy. Objective: To compare perioperative morbidity of the right versus left colectomy for cancer, as well as the quality of laparoscopic oncologic resection of both… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Disorders
- How many people
- 332 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2020to 1 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: colon adenocarcinoma
Who may be able to join
None listed.
Who cannot join
- Resections that included the rectum
- Exclusive transverse resections
- Multivisceral resections
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Medicine School, Sao Paulo University
São Paulo, 05403-900
Leonardo A Bustamante, Surgeon, 55 11 985000091, leo708@hotmail.com
Leonardo A Bustamante L, MD
About this study
Laparoscopic surgery decreased the morbidity of colorectal surgery. The two most common surgeries for colorectal cancer are right and left colectomy.
Objective: To compare perioperative morbidity of the right versus left colectomy for cancer, as well as the quality of laparoscopic oncologic resection of both procedures. Methods: Retrospective analysis of prospectively collected data from patients operated at the University of São Paulo School of Medicine, between 2006 and 2016. Postoperative complications were classified with scale within 30 days after surgery. Grade III or greater was considered serious complication. Quality of oncologic resection was assessed by the average number of lymph nodes harvested and surgical margins.
Read the detailed description
Laparoscopic surgery decreased the morbidity of colorectal surgery. The two most common surgeries for colorectal cancer are right and left colectomy.
This retrospective analysis of prospectively collected data from patients operated at the University of São Paulo School of Medicine, between 2006 and 2016. Postoperative complications were classified by scale within 30 days after surgery. There were 332 patients operated.
- Conditions
- Colorectal Disorders
- Keywords
- colectomy, colorectal, laparoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start2 Jan 2020
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal DisordersStudies 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
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leonardo Bustamante-Lopez
- Sponsor type
- University, hospital or other
- Collaborators
- Rodrigo Ambar Pinto
- Responsible party
- Sponsor-investigator, Leonardo Bustamante-Lopez, University of Sao Paulo
- Investigators
- Rodrigo A Pinto, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461054
- Sponsor's protocol ID
- Colon USP
- Status last verified
- Jul 2020
- First submitted
- 28 Jun 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Type of Laparoscopic Colectomy, Right or Left, Have Better Postoperative Outcomes for the Patients?
- ClinicalTrials.gov ID
- NCT04461054
- Acronym / sponsor ID
- Colon USP
- Conditions
- Colorectal Disorders
- Keywords
- colectomy, colorectal, laparoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Leonardo Bustamante-LopezUniversity, hospital or other
- Collaborators
- Rodrigo Ambar Pinto
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 8 Jul 2020 (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.
Laparoscopic surgery decreased the morbidity of colorectal surgery. The two most common surgeries for colorectal cancer are right and left colectomy.
Objective: To compare perioperative morbidity of the right versus left colectomy for cancer, as well as the quality of laparoscopic oncologic resection of both procedures. Methods: Retrospective analysis of prospectively collected data from patients operated at the University of São Paulo School of Medicine, between 2006 and 2016. Postoperative complications were classified with scale within 30 days after surgery. Grade III or greater was considered serious complication. Quality of oncologic resection was assessed by the average number of lymph nodes harvested and surgical margins.
Detailed description
Laparoscopic surgery decreased the morbidity of colorectal surgery. The two most common surgeries for colorectal cancer are right and left colectomy.
This retrospective analysis of prospectively collected data from patients operated at the University of São Paulo School of Medicine, between 2006 and 2016. Postoperative complications were classified by scale within 30 days after surgery. There were 332 patients operated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- colon adenocarcinoma
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Resections that included the rectum
- Exclusive transverse resections
- Multivisceral resections
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
Postoperative complications
Time frame: 30 days
Complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
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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.
Rodrigo A Pinto, MD, PhD principal investigator
University of Sao Paulo
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 Colorectal Disorders, run by Leonardo Bustamante-Lopez at 1 site in Brazil.
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 0 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Jul 2020. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonardo A Bustamante-Lopez, MD, PhD (55 11 985000091, leonardoabustamante@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: 30 days). 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 8 Jul 2020.