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Clinical Trials/NCT01418807
NCT01418807CompletedPhase 2

Transumbilical Versus Transvaginal Specimen Retrieval at Minilaparoscopy

Università degli Studi dell'Insubria2 sites in 1 country56 target enrollmentStarted: July 1, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
56
Locations
2
Primary Endpoint
Postoperative Pain
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

We hypothesise that pain at minilaparoscopy for gynecologic disease is reduced when transvaginal rather than transumbilical specimen extraction is accomplished. This would be due to the avoidance of a 10-mm port in the umbilicus. Visual analogue scale score of post-operative pain will be obtained and patients satisfaction will be asked at the 2-month postoperative visit.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adnexal Mass
  • •Benign Gynecologic Condition
  • •Laparoscopicb Surgery

Exclusion Criteria

  • •Obliteration Of The Douglas Pouch

Outcomes

Primary Outcomes

Postoperative Pain

Time Frame: 3 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Università degli Studi dell'Insubria
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fabio Ghezzi

Professor

Università degli Studi dell'Insubria

Study Sites (2)

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