Risk Factors for Early POCD in the Patients With PSM Undergoing CRS-HIPEC

Completed

• Conditions: Postoperative Cognitive Dysfunction

• Registration Number: NCT02462564
• Lead Sponsor: Wuhan University

Brief Summary

Objectives to investigate the incidence and associated factors for early postoperative cognitive dysfunction in the patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy(CRS-HIPEC).Methods fifty patients aged 18-65 yr were included in the research and were grouped base on the score of neuropsychological assessments which had done in the ward at 7 day before and after the surgery. The investigators monitored various indicators in the perioperative period, such as age, body weight, sex, education, duration of operation, intraoperative blood loss, cardiovascular events, amount of fluid infused per hour. Meanwhile, the concentration of serum amploid A (SAA),IL-1beta,TNF-alpha,HMGB1,S100b,cortisol and Abeta40 were measured at the various stage of the operation and 24 hours after the operation, and the differences of data between postoperative cognitive dysfunction(POCD) and Non-POCD groups were analyzed.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-01
• Study First Submitted: 2015-01-30
• Study Completion: 2015-06
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-04
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-16
• Last Update Posted: 2015-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• age < 65 years or >18 years
• The patients with peritoneal surface malignancies willing to undergo the cytoreductive surgery with hyperthermic intraperitoneal chemotherapy

Exclusion Criteria

• age < 18 years or >65 years
• several organ function severely abnormal and can not tolerate the surgery,such as suffering from severely anemia, liver and renal function disfunction, heart and cerebrovascular disease
• cognitive function was assessed by Mini-Mental State Examination (MMSE) at 1 day before operation and the score<23
• people with neurological and psychiatric disease, such as anxiety, senile dementia, stroke sequela, cerebral hemorrhage, etc
• psychiatric drug abusers
• patients reluctant to go along with the trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence for early postoperative cognitive dysfunction in the patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy	12 months

Secondary Outcome Measures

Name	Time	Method
Risk factor for early postoperative cognitive dysfunction in the patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy	12 months

Trial Locations

Locations (1)

Zhongnan Hospital in Wuhan University; 🇨🇳 Wuhan, Hubei, China