NCT01418807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for phase_2 postoperative-pain

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_2 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 24, 2012

Status Verified

February 1, 2012

Enrollment Period

5 months

First QC Date

August 16, 2011

Last Update Submit

February 23, 2012

Conditions

Postoperative PainPatients SatisfactionIntraoperative ComplicationsPostoperative Complications

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

    3 months

Study Arms (2)

TRANSVAGINAL EXTRACTION

EXPERIMENTAL
Procedure: TRANSVAGINAL SPECIMEN EXTRACTION

TRANSUMBILICAL EXTRACTION

ACTIVE COMPARATOR
Procedure: TRANSUMBILICAL SPECIMEN EXTRACTION

Interventions

TRANSVAGINAL SPECIMEN EXTRACTIONPROCEDURE

Transvaginal specimen retrieval following posterior colpotomy

TRANSVAGINAL EXTRACTION
TRANSUMBILICAL SPECIMEN EXTRACTIONPROCEDURE

Transumbilical specimen retrieval following enlargement of the umbilical port

TRANSUMBILICAL EXTRACTION

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adnexal Mass
  • Benign Gynecologic Condition
  • Laparoscopicb Surgery

You may not qualify if:

  • Obliteration Of The Douglas Pouch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology Universita' Dell'Insubria

Varese, 21100, Italy

Location

MeSH Terms

Conditions

Pain, PostoperativeIntraoperative ComplicationsPostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 16, 2011

First Posted

August 17, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 24, 2012

Record last verified: 2012-02

Locations

IT(1)