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

U

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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