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

Not Applicable

• Conditions: Adnexal Benign Pathology
• Interventions: Procedure: Low pression pneumoperitoneum; Procedure: Standard Pression Pneumoperitoneum; Procedure: Single Port Access Laparoscopy

• 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

Study Timeline

• Status Verified: 2015-12
• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2015-12-08
• Last Update Submitted: 2015-12-08
• Study First Posted: 2015-12-09
• Last Update Posted: 2015-12-09
• Study Start: 2016-01
• Primary Completion: 2017-10
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low pression pneumoperitoneum	Low pression pneumoperitoneum	Patients undergoing Single Port Access Laparoscopy for benign adnexal pathology with use of Low Pression Pneumoperitoneum (8 mm Hg)
Low pression pneumoperitoneum	Single Port Access Laparoscopy	Patients undergoing Single Port Access Laparoscopy for benign adnexal pathology with use of Low Pression Pneumoperitoneum (8 mm Hg)
Standard pression pneumoperitoneum	Standard Pression Pneumoperitoneum	Patients undergoing Single Port Access Laparoscopy for benign adnexal pathology with use of Standard Pression Pneumoperitoneum (12 mm Hg)
Standard pression pneumoperitoneum	Single Port Access Laparoscopy	Patients undergoing Single Port Access Laparoscopy for benign adnexal pathology with use of Standard Pression Pneumoperitoneum (12 mm Hg)

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
Postoperative pain measured on a VAS scale	24 hours	Experienced pain over the last 24 hours measured on a VAS scale.
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.