Transumbilical Versus Transvaginal Specimen Retrieval at Minilaparoscopy

Postoperative Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418807
• Other study ID #: mini-LPS Specimen extraction
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 16, 2011
• Last updated: February 23, 2012
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics Committee: Comitato Etico dell'Ospedale di Circolo
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Adnexal Mass

• Benign Gynecologic Condition

• Laparoscopicb Surgery

Exclusion Criteria:

• Obliteration Of The Douglas Pouch

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraoperative Complications
• Pain, Postoperative
• Patients Satisfaction
• Postoperative Complications
• Postoperative Pain

Intervention

Procedure:
• TRANSVAGINAL SPECIMEN EXTRACTION
Transvaginal specimen retrieval following posterior colpotomy
• TRANSUMBILICAL SPECIMEN EXTRACTION
Transumbilical specimen retrieval following enlargement of the umbilical port

Locations

Country	Name	City	State
Italy	Department of Obstetrics and Gynecology Universita' Dell'Insubria	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain		3 months	No