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Transumbilical Versus Transvaginal Specimen Retrieval at Minilaparoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01418807
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : February 24, 2012
Information provided by (Responsible Party):
Fabio Ghezzi, Università degli Studi dell'Insubria

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Patients Satisfaction Intraoperative Complications Postoperative Complications Procedure: TRANSVAGINAL SPECIMEN EXTRACTION Procedure: TRANSUMBILICAL SPECIMEN EXTRACTION Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Transvaginal specimen retrieval following posterior colpotomy

Transumbilical specimen retrieval following enlargement of the umbilical port

Primary Outcome Measures :
  1. Postoperative Pain [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adnexal Mass
  • Benign Gynecologic Condition
  • Laparoscopicb Surgery

Exclusion Criteria:

  • Obliteration Of The Douglas Pouch

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01418807

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Department of Obstetrics and Gynecology Universita' Dell'Insubria
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria

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Responsible Party: Fabio Ghezzi, Professor, Università degli Studi dell'Insubria Identifier: NCT01418807     History of Changes
Other Study ID Numbers: mini-LPS Specimen extraction
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: February 24, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Intraoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms