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

December 8, 2015 updated by: Stefano Angioni, University of Cagliari
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low pression pneumoperitoneum
Patients undergoing Single Port Access Laparoscopy for benign adnexal pathology with use of Low Pression Pneumoperitoneum (8 mm Hg)
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: 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
Experimental: Standard pression pneumoperitoneum
Patients undergoing Single Port Access Laparoscopy for benign adnexal pathology with use of Standard Pression Pneumoperitoneum (12 mm Hg)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain measured on a VAS scale
Time Frame: 6 hours
Experienced pain over the last six hours measured on a VAS scale
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: 0 hours after the operation
Operating time in minutes.
0 hours after the operation
Complications
Time Frame: Two months
Complications during surgery and late complications.
Two months
Blood loss in ml
Time Frame: 0 hours after the operation
Estimated blood loss in ml.
0 hours after the operation
Shoulder tip pain measured on a VAS scale
Time Frame: 24 hours
Experienced shoulder tip pain over the last 24 hours measured on a VAS scale.
24 hours
Postoperative pain measured on a VAS scale
Time Frame: 24 hours
Experienced pain over the last 24 hours measured on a VAS scale.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cagliari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

December 4, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Estimate)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 8, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • SPALPression

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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