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

NCT02625025 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-12-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Cagliari

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-10-31
Completion
2018-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02625025 on ClinicalTrials.gov