Teleassisted Surgery for Gynecological Disease in Obese Patients

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-02-29

Brief Summary

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Phase II prospective single-institutional study.

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Detailed Description

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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.

Conditions

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Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telelap ALF-X in obese patients with gynecological disease

Group Type EXPERIMENTAL

Telelap ALF-X

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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ALF-X teleassisted surgery

Eligibility Criteria

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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