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Transumbilical Versus Transvaginal Specimen Retrieval at Minilaparoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fabio Ghezzi, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT01418807
First received: August 16, 2011
Last updated: February 23, 2012
Last verified: February 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment

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

Primary Outcome Measures:
  • Postoperative Pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418807

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

No publications provided

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
Study First Received: August 16, 2011
Last Updated: February 23, 2012
Health Authority: Ethics Committee: Comitato Etico dell'Ospedale di Circolo

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

ClinicalTrials.gov processed this record on June 17, 2013