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

NCT ID: NCT02625025

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-01-31

Brief Summary

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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

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Conditions

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Adnexal Benign Pathology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low pression pneumoperitoneum

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

Group Type EXPERIMENTAL

Low pression pneumoperitoneum

Intervention Type PROCEDURE

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.

Single Port Access Laparoscopy

Intervention Type PROCEDURE

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

Standard pression pneumoperitoneum

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

Group Type EXPERIMENTAL

Standard Pression Pneumoperitoneum

Intervention Type PROCEDURE

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 Laparoscopy

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Cagliari

OTHER

Sponsor Role lead

Responsible Party

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Stefano Angioni

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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SPALPression

Identifier Type: -

Identifier Source: org_study_id