Limb Remote Ischemic Preconditioning for Heart and Intestinal Protection During Laparoscopic Colorectal Surgery

Laparoscopic Colorectal Surgery Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01832337
• Other study ID #: ????E201215?
• Status: Recruiting
• Phase: N/A
• First received: March 16, 2013
• Last updated: April 11, 2013
• Start date: October 2012

Study information

• Verified date: April 2013
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Fei Li
• Phone: 86-13580374947
• Email: lifei2006mz[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• age >40 years old

• ASA I-II

• receive elective laparoscopic colorectal surgery

• written informed consent can be obtained

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Laparoscopic Colorectal Surgery

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	the Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes