Transumbilical Versus Transvaginal Specimen Retrieval at Minilaparoscopy

NCT ID: NCT01418807

Last Updated: 2012-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain Patients Satisfaction Intraoperative Complications Postoperative Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TRANSVAGINAL EXTRACTION

Group Type EXPERIMENTAL

TRANSVAGINAL SPECIMEN EXTRACTION

Intervention Type PROCEDURE

Transvaginal specimen retrieval following posterior colpotomy

TRANSUMBILICAL EXTRACTION

Group Type ACTIVE_COMPARATOR

TRANSUMBILICAL SPECIMEN EXTRACTION

Intervention Type PROCEDURE

Transumbilical specimen retrieval following enlargement of the umbilical port

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TRANSVAGINAL SPECIMEN EXTRACTION

Transvaginal specimen retrieval following posterior colpotomy

Intervention Type PROCEDURE

TRANSUMBILICAL SPECIMEN EXTRACTION

Transumbilical specimen retrieval following enlargement of the umbilical port

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adnexal Mass
* Benign Gynecologic Condition
* Laparoscopicb Surgery

Exclusion Criteria

* Obliteration Of The Douglas Pouch
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Università degli Studi dell'Insubria

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fabio Ghezzi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Obstetrics and Gynecology Universita' Dell'Insubria

Varese, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

mini-LPS Specimen extraction

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.