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Transumbilical Versus Transvaginal Specimen Retrieval at Minilaparoscopy

Primary Purpose

Postoperative Pain, Patients Satisfaction, Intraoperative Complications

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
TRANSVAGINAL SPECIMEN EXTRACTION
TRANSUMBILICAL SPECIMEN EXTRACTION
Sponsored by
Università degli Studi dell'Insubria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Adnexal Mass
  • Benign Gynecologic Condition
  • Laparoscopicb Surgery

Exclusion Criteria:

  • Obliteration Of The Douglas Pouch

Sites / Locations

  • Department of Obstetrics and Gynecology Universita' Dell'Insubria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TRANSVAGINAL EXTRACTION

TRANSUMBILICAL EXTRACTION

Arm Description

Outcomes

Primary Outcome Measures

Postoperative Pain

Secondary Outcome Measures

Full Information

First Posted
August 16, 2011
Last Updated
February 23, 2012
Sponsor
Università degli Studi dell'Insubria
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1. Study Identification

Unique Protocol Identification Number
NCT01418807
Brief Title
Transumbilical Versus Transvaginal Specimen Retrieval at Minilaparoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi dell'Insubria

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Patients Satisfaction, Intraoperative Complications, Postoperative Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRANSVAGINAL EXTRACTION
Arm Type
Experimental
Arm Title
TRANSUMBILICAL EXTRACTION
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
TRANSVAGINAL SPECIMEN EXTRACTION
Intervention Description
Transvaginal specimen retrieval following posterior colpotomy
Intervention Type
Procedure
Intervention Name(s)
TRANSUMBILICAL SPECIMEN EXTRACTION
Intervention Description
Transumbilical specimen retrieval following enlargement of the umbilical port
Primary Outcome Measure Information:
Title
Postoperative Pain
Time Frame
3 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adnexal Mass Benign Gynecologic Condition Laparoscopicb Surgery Exclusion Criteria: Obliteration Of The Douglas Pouch
Facility Information:
Facility Name
Department of Obstetrics and Gynecology Universita' Dell'Insubria
City
Varese
ZIP/Postal Code
21100
Country
Italy

12. IPD Sharing Statement

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Transumbilical Versus Transvaginal Specimen Retrieval at Minilaparoscopy

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