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Phase 3
65 Years
N/A
Not Enrolling
Both
Surgery, Perioperative Care, Immunization, Abdominal Neoplasms

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Trial Information


Perioperative fluid administration is a common therapy in clinical practice, and recent
regime has a history about 50 years. Recently, clinicians found that traditional regime had
some disadvantages, for example, pulmonary edema, increased cardiac load, increased body
weight. And thus, perioperative fluid restriction regimen has been suggested and proved
could reduce cardiopulmonary complications and mortality rates after major elective
gastrointestinal surgery.

Patients were divided into two groups randomly and underwent restricted fluid regimen or
traditional fluid regimen. We determined the complications and immunological function in two
groups, and analyzed the relationship between complications and immunological changes. Based
on this we decide the probable mechanism that perioperative fluid restriction effects on
complications.


Inclusion Criteria:



- All patients(age≧65y) who was admitted for gastrointestinal cancer surgery were
considered eligible if they had no life-threatening systemic disease (ASA groups 1~3)

Exclusion Criteria:

- lactation

- mental disorders

- language problems

- smoking within two weeks

- diabetes mellitus

- renal insufficiency

- disseminated cancer

- secondary cancers

- inflammatory bowel disease, or diseases hindering epidural analgesia

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

clinical perioperative complications

Outcome Time Frame:

30 days after surgery

Safety Issue:

Yes

Authority:

China: National Natural Science Foundation

Study ID:

2009NLY031

NCT ID:

NCT01399814

Start Date:

May 2009

Completion Date:

October 2010

Related Keywords:

  • Surgery
  • Perioperative Care
  • Immunization
  • Abdominal Neoplasms
  • Abdominal Neoplasms
  • Neoplasms

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