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

University of Cagliari40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adnexal Benign Pathology

Interventions

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.

Standard Pression PneumoperitoneumPROCEDURE

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.

Single Port Access LaparoscopyPROCEDURE

Laparoscopy surgery with use of only one incision of 2 cm in the umbilicus in order to threat benign adnexal pathology

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Postoperative pain measured on a VAS scale

Experienced pain over the last six hours measured on a VAS scale

Time frame: 6 hours

Secondary Outcomes

Operation time

Operating time in minutes.

Time frame: 0 hours after the operation

Blood loss in ml

Estimated blood loss in ml.

Time frame: 0 hours after the operation

Complications

Complications during surgery and late complications.

Time frame: Two months

Shoulder tip pain measured on a VAS scale

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

Time frame: 24 hours

Postoperative pain measured on a VAS scale

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

Time frame: 24 hours

Data from ClinicalTrials.gov

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