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

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.

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Key information

Conditions

Postoperative Cognitive Dysfunction Abdominal Neoplasms Cognition Disorders Cognitive Dysfunction Digestive System Diseases Digestive System Neoplasms Mental Disorders Neoplasms Neoplasms by Site Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Peritoneal Neoplasms Postoperative Cognitive Complications Postoperative Complications

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongnan Hospital in Wuhan University

Wuhan, Hubei, 430074, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 12 months

Secondary outcomes

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

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Wuhan University

Other

Registry information

Official study title

Risk Factors for Early POCD(Postoperative Cognitive Dysfunction) in the Patients With PSM(Peritoneal Surface Malignancies )Undergoing CRS(Cytoreductive Surgery) and HIPEC(Hyperthermic Intraperitoneal Chemo-therapy)

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jun 4, 2015
Registry last updated: Aug 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed