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Transumbilical Versus Transvaginal Specimen Retrieval at Minilaparoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01418807
First Posted: August 17, 2011
Last Update Posted: February 24, 2012
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.
Information provided by (Responsible Party):
Fabio Ghezzi, Università degli Studi dell'Insubria
  Purpose
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 Intervention Phase
Postoperative Pain Patients Satisfaction Intraoperative Complications Postoperative Complications Procedure: TRANSVAGINAL SPECIMEN EXTRACTION Procedure: TRANSUMBILICAL SPECIMEN EXTRACTION Phase 2 Phase 3

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

Further study details as provided by Fabio Ghezzi, Università degli Studi dell'Insubria:

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

Enrollment: 56
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRANSVAGINAL EXTRACTION Procedure: TRANSVAGINAL SPECIMEN EXTRACTION
Transvaginal specimen retrieval following posterior colpotomy
Active Comparator: TRANSUMBILICAL EXTRACTION Procedure: TRANSUMBILICAL SPECIMEN EXTRACTION
Transumbilical specimen retrieval following enlargement of the umbilical port

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Adnexal Mass
  • Benign Gynecologic Condition
  • Laparoscopicb Surgery

Exclusion Criteria:

  • Obliteration Of The Douglas Pouch
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01418807


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

Responsible Party: Fabio Ghezzi, Professor, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT01418807     History of Changes
Other Study ID Numbers: mini-LPS Specimen extraction
First Submitted: August 16, 2011
First Posted: August 17, 2011
Last Update Posted: February 24, 2012
Last Verified: February 2012

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