Low vs Standard Pneumoperitoneum Pressure During Single Port Access Laparoscopic for Adnexal Pathology
- Conditions
- Adnexal Benign Pathology
- Registration Number
- NCT02625025
- Lead Sponsor
- University of Cagliari
- Brief Summary
During laparoscopy pneumoperitoneum creates the necessary space in which to perform the operation. Growing evidence in general surgery has shown that reduction of intra-abdominal pressure during laparoscopy is related to improved postoperative outcomes, decreased pain perception, length of hospital stay, and analgesic rescue dosage in patients undergoing minimally invasive procedures using low pneumoperitoneum pressure (LPP) compared with standard pneumoperitoneum pressure (SPP). Aim of the study is to demonstrate the safety and feasibility of LPP during performance of Single Port Access Laparoscopy for benign adnexal pathologies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 40
- patients 18- 45 years old
- elective laparoscopic operation
- informed consent
- BMI > 30 kg/cm2
- pregnancy
- converting to laparotomy
- malignant disease
- unable or unwilling to give written consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Postoperative pain measured on a VAS scale 6 hours Experienced pain over the last six hours measured on a VAS scale
- Secondary Outcome Measures
Name Time Method Operation time 0 hours after the operation Operating time in minutes.
Blood loss in ml 0 hours after the operation Estimated blood loss in ml.
Complications Two months Complications during surgery and late complications.
Shoulder tip pain measured on a VAS scale 24 hours Experienced shoulder tip pain over the last 24 hours measured on a VAS scale.
Postoperative pain measured on a VAS scale 24 hours Experienced pain over the last 24 hours measured on a VAS scale.