Results of CRS and Debulking in PMP Patients | NCT01427101

Studies
Results of CRS and Debulking in PMP Patients

NCT01427101

Sponsor

Uppsala University

Status

Unknown status

Last Update Posted

Sep 1, 2011Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Pseudomyxoma Peritonei

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1993

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 31, 2011

First Submission Date that Met QC Criteria

Aug 31, 2011

First Posted Date

Sep 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2011

Last Update Posted Date

Sep 1, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study was to compare debulking surgery and cytoreductive surgery in patients with Pseudomyxoma Peritonei with respect to efficacy and safety.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Not provided

Description

Enrollment

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	from treatment and forward

Secondary Outcomes

Measure	Description	Time Frame
morbidity and mortality	mortality is messured during the first 90 postoperative days and morbidity during hospital stay.	90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with radiology histopathology finding of Pseudomyxoma Peritonei

Exclusion Criteria:

Preformance status WHO >2 and histopathology shows other origin then Pseudomyxoma Peritonei

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Pseudomyxoma Peritonei, sceduled for surgical treatment at Uppsala University Hospital.

Sampling Method

Probability Sample

Name	Affiliation	Role
Haile Mahteme, MD, PhD	Uppsala University	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D011553	Pseudomyxoma Peritonei

Ancestor Terms

ID	Term
D002288	Adenocarcinoma, Mucinous
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial

Browse Leaves

Not provided

Browse Branches

Not provided

Patients treated from 1993 are included and during these years treatment strategy has changed. The different strategies are compared but its juts one cohort of patients. No completion date are set due to that reports from other centres show that there are longtime survivers in both treatment groups.