Clinical trial NCT03216759: Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications
Official title: Effects of Comprehensive Intestinal Protection Strategy on Postoperative Intestinal Complications in Patients Undergoing Laparotomy With General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intestinal Complications
Laparotomy
Keywords: Comprehensive intestinal protection strategy
Intestinal complications
laparotomy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate the morbidity of intestinal injury after open surgery and observe the effect of comprehensive intestinal protection strategy on postoperative intestinal complications in patients undergoing laparotomy with general anesthesia.

Detailed description: Perioperative intestinal injury is one of the common tissues and organs injury in surgical practice. However, there is a lack of effective means of prevention and treatment.The investigators previously found that ischemic preconditioning, IPC, and dexmedetomidine has protective effects on intestinal mucosal injury.

However, the combined effect of various factors has not been clinically validated. To explore the effect of comprehensive intestinal protection strategy on postoperative intestinal complications in patients undergoing laparotomy with general anesthesia,the investigators select the patients undergoing open surgery under general anesthesia as the study subjects and the concentration of intestinal fatty acid binding protein (I-FABP) as well as the incidence of digestive system complications in one week after operation are the main observation indexes.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 70 years;
* Elective abdominal surgery under general anesthesia, operation time \> 2h;
* ASA Ⅰ \~ Ⅲ;
* Patient informed and consent to accept the test.

Exclusion Criteria:

* persons under the age of 18 or over 70 years old;
* pregnant or lactating women;
* combined with lung, liver, kidney, cardiovascular and hematopoietic system disease and other serious primary disease;
* preoperative Hb \<7g / l;
* oral sulfa drugs or nicorandil antihypertensive drugs;
* lower extremity amputees;
* with peripheral vascular disease;
* patients with mental illness or severe neurosis;
* can not express the subjective symptoms;
* nearly 3 months to participate in other drug clinical trials;
* within 3 months of receiving other surgical treatment.

Primary outcomes:
measure: The incidence of digestive system complications after operation
timeFrame: 12 hours to one week after surgery
measure: The concentration of intestinal fatty acid-binding protein (I-FABP)
timeFrame: 12 h after operation
Secondary outcomes:
measure: Postoperative heart and respiratory complications within one week
timeFrame: 12 hours to one week after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Nanfang Hospital, the Southern Medical University
name: Ke-Xuan Liu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walsh SR, Sadat U, Boyle JR, Tang TY, Lapsley M, Norden AG, Gaunt ME. Remote ischemic preconditioning for renal protection during elective open infrarenal abdominal aortic aneurysm repair: randomized controlled trial. Vasc Endovascular Surg. 2010 Jul;44(5):334-40. doi: 10.1177/1538574410370788. Epub 2010 May 18.
citation: Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. doi: 10.1016/S0140-6736(07)61296-3.