Colorectal CancerNCT05563441
Laparoscopic Colorectal Resection in Elderly
An observational study of Colorectal Cancer, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This is a nested cohort study of OAMBP-01. Patients over 70 years old were enrolled into the data-analysis. The purpose of this study was to examine the feasibility and safety of laparoscopic colorectal resection in elderly patients from a single center, and to explore if there are advantages in laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2015to 31 Jan 2023
- 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 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: This is a nested cohort study of OAMBP-01, patients over 70 years old underwent laparotomic surgery were enrolled into the data analysis, compared with the laparotomic colorectal resection in the same time period. All eligible patients were identified by searching the database of the Gastrointestinal Surgery Centre, Third Affiliated Hospital of Sun Yat-sen University.
Who may be able to join
- 1. Patient underwent elective laparoscopic or laparotomic colorectal resection for cancer treatment; 2. Patient baseline characteristics and surgical information were available; 3. Patients with complete follow-up data.
Who cannot join
- 1. Emergency surgery for causes including bowel obstruction, bleeding, or perforation; 2. Multiple primary malignancies; 3. Failure to follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
Third Affiliated Hospital of Sun-Yat sen University
Guangzhou, Guangdong, 86510000
About this study
Official title: Safety and Effectiveness of Laparoscopic Colorectal Resection in Elderly Patients With Colorectal Cancer
This is a nested cohort study of OAMBP-01. Patients over 70 years old were enrolled into the data-analysis.
The purpose of this study was to examine the feasibility and safety of laparoscopic colorectal resection in elderly patients from a single center, and to explore if there are advantages in laparoscopic surgery.
Read the detailed description
Surgical resection remains the primary treatment for CRC. Despite advancements in surgical techniques, treating elderly cancer patients remains challenging for surgeons. Perioperative risk increases as elderly patients are susceptible to cardiovascular and respiratory diseases. In addition, it has been demonstrated that elderly individuals come with more locally advanced tumor and are more likely to have obstructive or disseminated disease at the time of presentation. In addition, aging diminishes a person's physiological capacity to withstand a major operation. Therefore, surgeons preferred to choose laparotomic colorectal resection to reduce surgical duration and morbidity..
The benefits of laparoscopic colorectal resections over laparotomic surgery have been clearly demonstrated in the general population. However, previous clinical trials comparing surgical approach between laparoscopy and laparotomy restricted the patient's age <75 years, we have limited information on short- and long-term safety and efficacy of elderly patients underwent laparoscopic colorectal resection.
The purpose of this study was to examine the feasibility and safety of laparoscopic colorectal resection in elderly patients from a single center, and to explore if there are advantages in laparoscopic surgery.
This is a nested cohort study of OAMBP-01. Patients over 70 years old were enrolled into the data-analysis.
- Conditions
- Colorectal Cancer
- Being tested
- laparoscopic surgery
- Keywords
- laparoscopy, laparotomy, elderly
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic surgeryProcedure or surgery
Patients over 70 years old underwent laparoscopic or laparotomic colorectal resection were enrolled.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic surgery | Patients over 70 years old underwent laparoscopic colorectal resection were enrolled. Receives: Procedure: laparoscopic surgery | |
| laparotomic surgery | Patients over 70 years old underwent laparotomic colorectal resection were enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
perioperative complications
include anastomotic leakage, surgical site infection, postoperative ileus, respiratory/urinary tract infection, and deep vein thrombosis (DVT)
Measured: 42 days after surgery
Secondary outcomes (2)
overall survival
long term prognosis
Measured: 5 years
disease free survival
long term prognosis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start20 Jan 2015
- Primary completion20 Dec 2019
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongbo Wei, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Purun Lei, M.D., Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563441
- Sponsor's protocol ID
- OAMBP-03
- Status last verified
- Apr 2023
- First submitted
- 29 Sep 2022
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Laparoscopic Colorectal Resection in Elderly Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05563441
- Acronym / sponsor ID
- OAMBP-03
- Conditions
- Colorectal Cancer
- Keywords
- laparoscopy, laparotomy, elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 20 Jan 2015 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 3 Oct 2022 (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.
This is a nested cohort study of OAMBP-01. Patients over 70 years old were enrolled into the data-analysis.
The purpose of this study was to examine the feasibility and safety of laparoscopic colorectal resection in elderly patients from a single center, and to explore if there are advantages in laparoscopic surgery.
Detailed description
Surgical resection remains the primary treatment for CRC. Despite advancements in surgical techniques, treating elderly cancer patients remains challenging for surgeons. Perioperative risk increases as elderly patients are susceptible to cardiovascular and respiratory diseases. In addition, it has been demonstrated that elderly individuals come with more locally advanced tumor and are more likely to have obstructive or disseminated disease at the time of presentation. In addition, aging diminishes a person's physiological capacity to withstand a major operation. Therefore, surgeons preferred to choose laparotomic colorectal resection to reduce surgical duration and morbidity..
The benefits of laparoscopic colorectal resections over laparotomic surgery have been clearly demonstrated in the general population. However, previous clinical trials comparing surgical approach between laparoscopy and laparotomy restricted the patient's age <75 years, we have limited information on short- and long-term safety and efficacy of elderly patients underwent laparoscopic colorectal resection.
The purpose of this study was to examine the feasibility and safety of laparoscopic colorectal resection in elderly patients from a single center, and to explore if there are advantages in laparoscopic surgery.
This is a nested cohort study of OAMBP-01. Patients over 70 years old were enrolled into the data-analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic surgery | – | Procedure: laparoscopic surgeryPatients over 70 years old underwent laparoscopic colorectal resection were enrolled. |
| laparotomic surgery | – | –Patients over 70 years old underwent laparotomic colorectal resection were enrolled. |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This is a nested cohort study of OAMBP-01, patients over 70 years old underwent laparotomic surgery were enrolled into the data analysis, compared with the laparotomic colorectal resection in the same time period. All eligible patients were identified by searching the database of the Gastrointestinal Surgery Centre, Third Affiliated Hospital of Sun Yat-sen University.
Key inclusion criteria (1 listed)
- 1. Patient underwent elective laparoscopic or laparotomic colorectal resection for cancer treatment; 2. Patient baseline characteristics and surgical information were available; 3. Patients with complete follow-up data.
Key exclusion criteria (1 listed)
- 1. Emergency surgery for causes including bowel obstruction, bleeding, or perforation; 2. Multiple primary malignancies; 3. Failure to follow-up.
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 |
|---|---|---|
| laparoscopic surgeryPatients over 70 years old underwent laparoscopic or laparotomic colorectal resection were enrolled. | Procedure or surgery | laparoscopic surgery |
Primary outcome
perioperative complications
Time frame: 42 days after surgery
include anastomotic leakage, surgical site infection, postoperative ileus, respiratory/urinary tract infection, and deep vein thrombosis (DVT)
2 secondary outcomes
overall survival
Time frame: 5 years
disease free survival
Time frame: 5 years
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 5 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Purun Lei, M.D. principal investigator
Third Affiliated Hospital, Sun Yat-Sen University
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 Cancer, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 1 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 5 Apr 2023. 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 China. 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?
perioperative complications (time frame: 42 days after surgery). 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 5 Apr 2023.