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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01640-53 | Registry Identifier | ID RCB |
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Airseal® is an insufflation management system for laparoscopic surgery which provides stable pneumoperitoneum, continuous smoke evacuation and valve-free access to the abdominal cavity. It allows an optimal exposure with a low-pression pneumoperitoneum, which is rarely possible with our standard insufflation system under a pneumoperitoneum of 12 millimetres of mercury(mmHg).
The objective of this study is to compare the use of Airseal® system with a low pression pneumoperitoneum and our standard insufflation system usually used in our center in term of postoperative abdominal pain after laparoscopic hysterectomy for benign disease.
This superiority prospective randomized trial is designed to include all patients > 18 years old referred for laparoscopic total hysterectomy for benign disease (with or without uni or bilateral annexectomy). Each patient would be randomized to one of this two following groups :
The primary end point is mean intensity of abdominal pain six hours after the end of surgery (H6), measured by simple numerical scale (ENS).
The secondary end points are:
It will be estimate that the use of Airseal® will reduce the mean abdominal pain at H6 post operative of 1 point on the simple numerical scale compared to our standard insufflation system, with a standard deviation of 1,5. Type 1 and 2 errors were set to the usual levels of 0,05 and 0,20 respectively (power of 80%). Assuming a 10% withdrawal rate, the sample size would be 80 patients (40 patients in each group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Airseal® | Experimental | Low pression laparoscopy with a 8 to 10 mmHg pneumoperitoneum. |
|
| Standard insufflator | Active Comparator | laparoscopy realised with our usual insufflation system and a 12 to 15 mmHg pneumoperitoneum. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airseal® | Device | Total laparoscopic hysterectomy: Approach according to the Open-Laparoscopy technique and use of the insufflation system. |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pain by simple numerical scale | The primary end point is mean intensity of abdominal pain measured by simple numerical scale. a score of 0 to 10 best describes the importance of the patient's pain. The score 0 corresponds to "no pain". Note 10 is the maximum "pain" imaginable | six hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Olivier ARNAUD, Director | Assistance Publique Hôpitaux de Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Marseille | Marseille | 13354 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35569811 | Result | Delecourt C, Tourette C, Crochet P, Pivano A, Hamouda I, Agostini A. Benefits of AirSeal System in Laparoscopic Hysterectomy for Benign Condition: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2022 Aug;29(8):1003-1010. doi: 10.1016/j.jmig.2022.05.005. Epub 2022 May 13. |
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| Standard insufflator | Device | Standard insufflator |
|