Teleassisted Surgery for Gynecological Disease in Obese Patients - OB-ALFX (OB-ALFX)

January 13, 2015 updated by: Prof. Giovanni Scambia, Catholic University of the Sacred Heart
Phase II prospective single-institutional study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of this Phase II prospective single-institutional study is to assess feasibility and early complications rate of Telelap ALF-X surgical treatment in obese patients affected by gynecological disease.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Rome
      • Rome,, Rome, Italy, 00168
        • Catholic University of Sacred Heart Rome,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • informed consent
  • 30 ≤ BMI < 40
  • ASA < III
  • Ovarian Cyst
  • Prophylactic bilateral salpingo-oophorectomy
  • Ectopic Pregnancy
  • Pelvic Inflammatory Disease
  • Sterility/Infertility
  • Benign uterine disease (fibromatosis, adenomyosis)
  • Endometrial hiperplasia
  • Early-stage Endometrial Cancer
  • Preneoplastic lesions of the cervix
  • IA1 Cervical Cancer
  • Pelvic endometriosis

Exclusion Criteria:

  • Pregnancy
  • Liver disease
  • Coagulopathies
  • Clinical conditions contraindicating laparoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telelap ALF-X in obese patients with gynecological disease
Device: Telelap ALF-X

Patients placed in the dorsal lithotomic position with both legs supported in Allen stirrups with a Trendelenburg tilt. After achieving pneumoperitoneum (12mmHg) through a trans umbilical open access technique, intra-abdominal visualization was obtained with a 10mm 0° HD 3D telescope. During the trocar placement the operative room nurses supported the surgeon in the docking procedures approaching the robotic arms to the operative table, in places established for pelvic surgery. The cockpit is located in one corner of our square shape room; the operative table is surrounded by the three robotic arms unit.

Through the teleassisted operative ports we could make use of several type of instruments. Movements of both instruments and optic were completely carried out by the surgeon from the cockpit according to the needs of the procedure.

Other Names:
  • ALF-X teleassisted surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative complication rate
Time Frame: intraoperative
Operative time, conversion rate, estimated blood loss, visceral injury
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complication rate
Time Frame: 30 days
Ileus, bleeding, infection/sepsi, thrombosis, rehospitalization, death
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Collaborators

SOFAR S.p.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 14, 2015

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21264/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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