NCT02462564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

7 months

First QC Date

January 30, 2015

Last Update Submit

August 16, 2015

Conditions

Postoperative Cognitive Dysfunction

Keywords

peritoneal surface malignanciesPost operative cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (1)

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

    12 months

Study Arms (2)

postoperative cognitive dysfunction

Z score\>1.96

non-postoperative cognitive dysfunction

Z score\<1.96

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital in Wuhan University

Wuhan, Hubei, 430074, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood sample

MeSH Terms

Conditions

Postoperative Cognitive ComplicationsPeritoneal Neoplasms

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental DisordersAbdominal NeoplasmsNeoplasms by SiteNeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal Diseases

Study Officials

  • Mian Peng, Doctor

    Zhongnan Hospital in Wuhan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 30, 2015

First Posted

June 4, 2015

Study Start

June 1, 2014

Primary Completion

January 1, 2015

Study Completion

June 1, 2015

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations

CN(1)