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

Study Overview
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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.

Conditions
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Adnexal Benign Pathology

Intervention / Treatment
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* Procedure: Low pression pneumoperitoneum
* Procedure: Standard Pression Pneumoperitoneum
* Procedure: Single Port Access Laparoscopy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low pression pneumoperitoneum<br>Patients undergoing Single Port Access Laparoscopy for benign adnexal pathology with use of Low Pression Pneumoperitoneum (8 mm Hg) | Procedure: Low pression pneumoperitoneum<br>* 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.<br>Procedure: Single Port Access Laparoscopy<br>* Laparoscopy surgery with use of only one incision of 2 cm in the umbilicus in order to threat benign adnexal pathology<br>|
| Experimental: Standard pression pneumoperitoneum<br>Patients undergoing Single Port Access Laparoscopy for benign adnexal pathology with use of Standard Pression Pneumoperitoneum (12 mm Hg) | Procedure: Standard Pression Pneumoperitoneum<br>* 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.<br>Procedure: Single Port Access Laparoscopy<br>* Laparoscopy surgery with use of only one incision of 2 cm in the umbilicus in order to threat benign adnexal pathology<br>|

What is the study measuring?
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Primary Outcome Measures

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