NCT02625025

Low vs Standard Pneumoperitoneum Pressure During Single Port Access Laparoscopic for Adnexal Pathology

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Cagliari · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Adnexal Benign Pathology

Interventions

Type	Name	Description
PROCEDURE	Low 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.
PROCEDURE	Standard 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.
PROCEDURE	Single Port Access Laparoscopy	Laparoscopy surgery with use of only one incision of 2 cm in the umbilicus in order to threat benign adnexal pathology

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-10-01
• Completion: 2018-01-01
• First posted: 2015-12-09
• Last updated: 2015-12-09