Limb Remote Ischemic Preconditioning for Heart and Intestinal Protection During Laparoscopic Colorectal Surgery
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 16, 2013
CompletedFirst Posted
Study publicly available on registry
April 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedApril 16, 2013
April 1, 2013
7 months
March 16, 2013
April 11, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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.
within the first 7 days after surgery
Study Arms (1)
precondition
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- age \>40 years old
- ASA I-II
- receive elective laparoscopic colorectal surgery
- written informed consent can be obtained
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fei Lilead
Study Sites (1)
the Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sixth Affiliated Hospital, Sun Yat-sen University
Study Record Dates
First Submitted
March 16, 2013
First Posted
April 16, 2013
Study Start
October 1, 2012
Primary Completion
May 1, 2013
Last Updated
April 16, 2013
Record last verified: 2013-04