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

Primary Purpose

Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis

Status

Unknown status

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Telelap ALF-X

About this trial

This is an interventional treatment trial for Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis focused on measuring Robotic Surgery, Telelap-ALFX, Gynecological disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Catholic University of Sacred Heart Rome,

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telelap ALF-X in obese patients with gynecological disease

Arm Description

Outcomes

Primary Outcome Measures

intraoperative complication rate

Operative time, conversion rate, estimated blood loss, visceral injury

Secondary Outcome Measures

postoperative complication rate

Ileus, bleeding, infection/sepsi, thrombosis, rehospitalization, death

Full Information

NCT ID

NCT02338505

First Posted

January 12, 2015

Last Updated

January 13, 2015

Sponsor

Catholic University of the Sacred Heart

Collaborators

SOFAR S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT02338505

Brief Title

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

Acronym

OB-ALFX

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Unknown status

Study Start Date

February 2015 (undefined)

Primary Completion Date

February 2016 (Anticipated)

Study Completion Date

February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Catholic University of the Sacred Heart

Collaborators

SOFAR S.p.A.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Phase II prospective single-institutional study.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis

Keywords

Robotic Surgery, Telelap-ALFX, Gynecological disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Telelap ALF-X in obese patients with gynecological disease

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Telelap ALF-X

Other Intervention Name(s)

ALF-X teleassisted surgery

Intervention Description

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.

Primary Outcome Measure Information:

Title

intraoperative complication rate

Description

Operative time, conversion rate, estimated blood loss, visceral injury

Time Frame

intraoperative

Secondary Outcome Measure Information:

Title

postoperative complication rate

Description

Ileus, bleeding, infection/sepsi, thrombosis, rehospitalization, death

Time Frame

30 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Salvatore Gueli Alletti, MD

gueliallettis@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Salvatore Gueli Alletti, MD

Facility Information:

Facility Name

Catholic University of Sacred Heart Rome,

City

Rome,

State/Province

Rome

ZIP/Postal Code

00168

Country

Italy

Facility Contact: