Adnexal Benign Pathology
Conditions
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.
Interventions
PROCEDURESingle Port Access Laparoscopy
Laparoscopy surgery with use of only one incision of 2 cm in the umbilicus in order to threat benign adnexal pathology
PROCEDURELow pression pneumoperitoneum
Pneumoperitoneum will be obtained by infusing carbon dioxide to distend the peritoneal cavity. Intra-abdominal pressure will be maintained at 8 mm Hg during pneumoperitoneum creation and insertion of trocars.
PROCEDUREStandard Pression Pneumoperitoneum
Pneumoperitoneum will be obtained by infusing carbon dioxide to distend the peritoneal cavity. Intra-abdominal pressure will be maintained at 12 mm Hg during pneumoperitoneum creation and insertion of trocars.
Sponsors
University of Cagliari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* patients 18- 45 years old * elective laparoscopic operation * informed consent
Exclusion criteria
* BMI \> 30 kg/cm2 * pregnancy * converting to laparotomy * malignant disease * unable or unwilling to give written consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain measured on a VAS scale | 6 hours | Experienced pain over the last six hours measured on a VAS scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed