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Clinical Trials/ACTRN12621000070831
ACTRN12621000070831
Recruiting
Phase 2

A four arm, multi-centered, randomized, blinded, placebo-controlled phase 2 study in gynaecological patients undergoing a total laparoscopic hysterectomy comparing Pulmonary RecruItment Maneuver with closed Drainage vs. closed drainage vs. pulmonary recruitment vs. placebo in reducing shoulder tip pain.

St John of God Subiaco Hospital WA0 sites264 target enrollmentJanuary 28, 2021

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
St John of God Subiaco Hospital WA
Enrollment
264
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 28, 2021
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
St John of God Subiaco Hospital WA

Eligibility Criteria

Inclusion Criteria

  • 1\. All women aged 18 years and over undergoing total laparoscopic hysterectomy
  • 2\. American Society of Anesthesilogists (ASA) Score 1 or 2
  • 3\. Undergoing a total laparascopic hysterectomy for one of the following conditions:\-
  • 1\. Abnormal uterine bleeding.
  • 2\.Early stage uterine cancer
  • 3\.Atypical hyperplasia
  • 4\. Uterine fibroids where the uterine size should not exceed 10cm.
  • 5\. Risk reducing surgery

Exclusion Criteria

  • 1\.Pregnancy
  • 2\.Endometriosis
  • 3\.Severe lung disorder
  • 4\.Pre\-operative shoulder or neck pain
  • 5\.Chronic pelvic pain
  • 6\.Severe Cardiovascular disease
  • 7\.History of high intracranial pressure
  • 8\.Not proficient in English

Outcomes

Primary Outcomes

Not specified

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