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The goal of this clinical trial is to learn if low pressure pneumoperitoneum and small incisions (low impact laparoscopy, LIL) works to reduce pain and improve pulmonary function in patients underwent to bariatric surgery.
It will also learn about the safety and patients' satisfaction of the procedure. The main questions it aims to answer are:
Does LIL lower post surgical pain and improve pulmonary function? Is LIL safe for obese patients? Researchers will compare LIL to standard laparoscopy performing sleeve gastrectomy in patients with obesity.
Participants will:
be randomised to LIL group or standard laparoscopy. After the operation the researchers will evaluate the pain and the efficiency of lung ventilation at pre-established intervals. after 3 months the patients will complete a questionnaire on aesthetic satisfaction and overall satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Pneumoperitoneum Laparoscopy with microsurgery | Experimental |
| |
| standard laparoscopy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low pneumoperitoneum laparoscopy with microsurgery | Procedure | Use of low pressure for pneumoperitoneum (8-10 mmHg) and mini surgical access for bariatric procedure (sleeve gastrectomy). |
| Measure | Description | Time Frame |
|---|---|---|
| POST OPERATIVE PAIN | Post-operative pain (AS REST PAIN AND MOVIMENT PAIN) will be assessed using the Numeric Pain Rating Scale (NRS), which rates pain from 0 to 10. 0 is defined as no pain, while 10 represents the maximum pain. 0 is the best result, 10 the worst. The questionnaire will be administered in the PACU and at 6, 12, 24, and 36 hours after the end of the procedure. | FROM THE ENTER IN PACU TO 36 HOURS POST- SURGERY |
| Pulmonary performance | Efficiency of ventilation will be evaluated recording the values of Maximum Inspiratory Pressure (MIP), maximum expiratory pressure (MEP), Peak expiratory flow (PEF) | from surgery to 24 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| USE OF Analgesics | Comparison of analgesic use between the two groups during post-operative recovery | from surgery to 36 hours post-surgery |
| operative time | Comparison of opertive time between the two groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincenzo Bruni | Contact | +39 3484064965 | v.bruni@policlinicocampus.it | |
| Ida Francesca Gallo | Contact | +393926237399 | i.gallo@policlinicocampus.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Campus Bio-Medico | Recruiting | Rome | Italy | 00128 | Italy |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008866 | Microsurgery |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D008846 | Micromanipulation |
| D008919 | Investigative Techniques |
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| standard laparoscopy | Procedure | Standard laparoscopy (12-14 mmHg) and normal surgical access for bariatric procedures (sleeve gastrectomy). |
|
| from the surgical incision to the last skin stitch |
| Rate of conversion to standard laparoscopy | Record the number of cases in the operative group where conversion to a standard laparoscopic approach was necessary, with pressure values > 10 mmHg for more than 20% of the duration of the procedure. Also analyzing the results for BMI subgroups. | from the beginning of surgery to the end of surgery |
| Rate of laparotomy conversion | Number of cases in which the surgical procedure had to be converted from laparoscopy to an open approach. | from the beginning of surgery to the end of surgery |
| Ambulation Time | Comparison of mobilization time between the two groups | From the end of surgery up to 24 hours post-surgery |
| The time to first flatus | Compare the time to intestinal motility recovery between the two groups. | From the end of surgery up to 48 hours post-surgery |
| Liver Function | Comparison between the two groups of liver function tests that include alanine transaminase (ALT, Normal values 0-55 U/L) , aspartate transaminase (AST, normal values 5-34 U/L), alkaline phosphatase (ALP normal values 53-141 U/L) and gamma-glutamyl transferase (GGT, normal values 8-33 U/L). | first and second post-operative day |
| Post-operative hospital stay | Post-operative hospital stay | from the day of surgery up to 30 days |
| Postoperative complications | All postoperative complications | from surgery to 30 days after surgery |
| First Operator Comfort | Evaluate the comfort of the operating surgeon related to the adequate exposure of the surgical field during the procedure using a 5-point surgical rating scale for laparoscopic surgical workspace. The scale ranges from 1 to 5, where 1 corresponds to the worst possible outcome, while 5 represents the best possible outcome. | during surgery |
| Aesthetic satisfaction | Evaluate the degree of aesthetic and overall satisfaction of patients by administering to them, 3 months after the intervention, the Patient Scar Assessment Scale (PSAS), a validated tool for scar assessment, and the Ultimate Question (UQ), related to overall satisfaction. These tests are administered together and the patient, who responds to 8 different items, assigning a score from 1 to 10. The maximum test score is 80, indicating the highest satisfaction, while the minimum score is 8, corresponding to the worst possible outcome. | from surgery to 3-month post surgery |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |