Teleassisted Surgery for Gynecological Disease in Obese Patients - OB-ALFX
Phase 2
- Conditions
- Benign, Premalignant and Malignant Gynecological Disease Confined to the Pelvis
- Interventions
- Device: Telelap ALF-X
- Registration Number
- NCT02338505
- Lead Sponsor
- Catholic University of the Sacred Heart
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 50
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Telelap ALF-X in obese patients with gynecological disease Telelap ALF-X -
- Primary Outcome Measures
Name Time Method intraoperative complication rate intraoperative Operative time, conversion rate, estimated blood loss, visceral injury
- Secondary Outcome Measures
Name Time Method postoperative complication rate 30 days Ileus, bleeding, infection/sepsi, thrombosis, rehospitalization, death
Trial Locations
- Locations (1)
Catholic University of Sacred Heart Rome,
🇮🇹Rome,, Rome, Italy