Laparoscopic Colorectal SurgeryNCT01832337
Limb Remote Ischemic Preconditioning for Heart and Intestinal Protection During Laparoscopic Colorectal Surgery
A study testing Limb remote ischemic preconditioning (LRIP) in people with Laparoscopic Colorectal Surgery, run by Fei Li at 1 site in China.
Trial summary
Remote ischaemic preconditioning may confer the cytoprotection in critical organs. The investigators hypothesized that limb remote ischemic preconditioning (RIPC) would reduce heart and gastrointestinal function injury in middle-aged and elderly patients undergoing elective laparoscopic colorectal surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Laparoscopic Colorectal Surgery
- What is being tested?
- Limb remote ischemic preconditioning (LRIP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to May 2013
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >40 years old
- ASA I-II
- receive elective laparoscopic colorectal surgery
- written informed consent can be obtained
Who cannot join
- coagulation disorders
- patients with cardiac pacemaker
- patients with severe cardiac,or pulmonary,hepatic,renal disease ,or can not tolerate laparoscopic surgery
- patients with peripheral vascular disease affecting the upper limbs
- patients with mental,or hearing, vision disorder, who is not able to communicate with physicians
- difficult airways that can not receive rapid induction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Fei Li, 13580374947
About this study
Remote ischaemic preconditioning may confer the cytoprotection in critical organs. The investigators hypothesized that limb remote ischemic preconditioning (RIPC) would reduce heart and gastrointestinal function injury in middle-aged and elderly patients undergoing elective laparoscopic colorectal surgery.
- Conditions
- Laparoscopic Colorectal Surgery
- Being tested
- Limb remote ischemic preconditioning (LRIP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limb remote ischemic preconditioning (LRIP)Procedure or surgery
Limb remote ischemic preconditioning (LRIP) consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated.
| Study group | Role | What they receive |
|---|---|---|
| precondition | Experimental | Not described Receives: Procedure: Limb remote ischemic preconditioning (LRIP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb remote ischemic preconditioning may have effective protection of heart and intestinal in middle-aged and elderly patients undergoing elective laparoscopic colorectal surgery.
We hypothesized that limb remote ischemic preconditioning (RIPC) would reduce heart and intestinal injury in patients undergoing elective laparoscopic colorectal surgery.The primary outcomes included the biomarkers reflecting intestinal injury (serum intestinal fatty acid binding protein, endotoxin levels and),time (hours) from end of operation to first passage of stool or flatus,the biomarker reflecting heart injury (CTnI,serum heart fatty acid binding protein ).Perioperative electrocardiographic was also recorded. In addition, the severity of intestinal injury was assessed with pathological scoring methods. Markers of systemic inflammation (CRP) were measured as well.
Measured: within the first 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startOct 2012
- Primary completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Colorectal SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fei Li, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832337
- Sponsor's protocol ID
- 伦研批第E201215号
- Status last verified
- Apr 2013
- First submitted
- 16 Mar 2013
- Last updated
- 16 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limb Remote Ischemic Preconditioning for Heart and Intestinal Protection During Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01832337
- Acronym / sponsor ID
- 伦研批第E201215号
- Conditions
- Laparoscopic Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fei LiUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2013 (estimated)
- First posted
- 16 Apr 2013 (estimated)
- 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.
Remote ischaemic preconditioning may confer the cytoprotection in critical organs. The investigators hypothesized that limb remote ischemic preconditioning (RIPC) would reduce heart and gastrointestinal function injury in middle-aged and elderly patients undergoing elective laparoscopic colorectal surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| precondition | Experimental | Procedure: Limb remote ischemic preconditioning (LRIP) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age >40 years old
- ASA I-II
- receive elective laparoscopic colorectal surgery
- written informed consent can be obtained
Key exclusion criteria (6 listed)
- coagulation disorders
- patients with cardiac pacemaker
- patients with severe cardiac,or pulmonary,hepatic,renal disease ,or can not tolerate laparoscopic surgery
- patients with peripheral vascular disease affecting the upper limbs
- patients with mental,or hearing, vision disorder, who is not able to communicate with physicians
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 |
|---|---|---|
| Limb remote ischemic preconditioning (LRIP)Limb remote ischemic preconditioning (LRIP) consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated. | Procedure or surgery | precondition |
Primary outcome
Limb remote ischemic preconditioning may have effective protection of heart and intestinal in middle-aged and elderly patients undergoing elective laparoscopic colorectal surgery.
Time frame: within the first 7 days after surgery
We hypothesized that limb remote ischemic preconditioning (RIPC) would reduce heart and intestinal injury in patients undergoing elective laparoscopic colorectal surgery.The primary outcomes included the biomarkers reflecting intestinal injury (serum intestinal fatty acid binding protein, endotoxin levels and),time (hours) from end of operation to first passage of stool or flatus,the biomarker reflecting heart injury (CTnI,serum heart fatty acid binding protein ).Perioperative electrocardiographic was also recorded. In addition, the severity of intestinal injury was assessed with pathological scoring methods. Markers of systemic inflammation (CRP) were measured as well.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limb remote ischemic preconditioning (LRIP) in people with Laparoscopic Colorectal Surgery, run by Fei Li 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 4 inclusion and 6 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 16 Apr 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Li (86-13580374947, lifei2006mz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb remote ischemic preconditioning may have effective protection of heart and intestinal in middle-aged and elderly patients undergoing elective laparoscopic colorectal surgery. (time frame: within the first 7 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 16 Apr 2013.