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

University of Cagliari

Status: Unknown

Conditions: Adnexal Benign Pathology

Treatments: Procedure: Single Port Access Laparoscopy; Procedure: Low pression pneumoperitoneum; Procedure: Standard Pression Pneumoperitoneum

Study type: Interventional

Funder types: Other

Identifiers

NCT02625025

SPALPression

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Low pression pneumoperitoneum

Experimental group

Description:

Patients undergoing Single Port Access Laparoscopy for benign adnexal pathology with use of Low Pression Pneumoperitoneum (8 mm Hg)

Treatment:

Procedure: Single Port Access Laparoscopy

Procedure: Low pression pneumoperitoneum

Standard pression pneumoperitoneum

Experimental group

Description:

Patients undergoing Single Port Access Laparoscopy for benign adnexal pathology with use of Standard Pression Pneumoperitoneum (12 mm Hg)

Treatment:

Procedure: Standard Pression Pneumoperitoneum

Procedure: Single Port Access Laparoscopy