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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Fei Li, Sixth Affiliated Hospital, Sun Yat-sen University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Fei Li, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01832337
First received: March 16, 2013
Last updated: April 11, 2013
Last verified: April 2013
  Purpose
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.

Condition Intervention
Laparoscopic Colorectal Surgery Procedure: Limb remote ischemic preconditioning (LRIP)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention

Further study details as provided by Fei Li, Sixth Affiliated Hospital, Sun Yat-sen University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: precondition 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.

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832337

Contacts
Contact: Fei Li 86-13580374947 lifei2006mz@126.com

Locations
China, Guangdong
the Sixth Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Fei Li    13580374947      
Sponsors and Collaborators
Fei Li
  More Information

Responsible Party: Fei Li, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01832337     History of Changes
Other Study ID Numbers: 伦研批第E201215号
Study First Received: March 16, 2013
Last Updated: April 11, 2013

ClinicalTrials.gov processed this record on June 23, 2017