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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00602-39 | Other Identifier | ANSM |
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This is a phase III, monocenter and randomized study, which evaluates the effectiveness of peritoneal gas drainage on postoperative pain in laparoscopic or robotic laparoscopic gynaecological surgery. This study aim is to assess the efficacy of active gas extraction with a drain (arm A) in comparison to manual evacuation (arm B,) in terms of pain incidence reduction linked to laparoscopic or robotic laparoscopic surgery.
The primary objective is to assess the efficacy of active gas aspiration compared to simple manual gas evacuation to reduce the incidence of specific laparoscopic surgery pain.
Secondary objectives of this study include :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A :Aspiration of peritoneal gas through a drain | Experimental | Patients in experimental arm will receive surgery (either laparoscopic or robotised laparoscopic surgery). The exsufflation will be carrying out by a drain. Then, patients will be followed-up during 7 days after surgery. |
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| Arm B : Manual evacuation of the peritoneal gas, via the trocar | Active Comparator | Laparoscopic or robotised laparoscopic surgery + Trocar Patient in this experimental arm will receive surgery (either laparoscopic or robotised laparoscopic surgery). The exsufflation will be carrying out carried out manually using the trocar (standard of care).Then, patient will be followed-up during 7 days after surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drain | Procedure | A 10 mm suction drain is placed through a trocar in the right hypochondrium (liver). |
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| Measure | Description | Time Frame |
|---|---|---|
| Specific pain (shoulders and/or subcostal areas) related to the laparoscopic surgery (Day 0), measured with a numerical pain assessment scale (score from 0 to 10) | Comparison on portion of patients with significative early pain linked to the laparoscopic surgery, between the two groups (Chi-2 tests). | During the 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal score pain, measured with a numerical pain assessment scale (score from 0 to 10) | The maximum score pain will be evaluated by the mean difference between each group (Student or Mann-Whitney tests). | 24 hours after surgery |
| Assess pain at trocar holes comparatively in the two groups |
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Inclusion Criteria:
Per-operatory eligibility criterion :
Exclusion Criteria:
Non eligibility criterion known during the operation :
Gynaecological cancer
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| Name | Affiliation | Role |
|---|---|---|
| Fabrice NARDUCCI, PhD | Centre Oscar Lambret | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fabrice NARDUCCI | Lille | 59020 | France |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D004322 | Drainage |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Patient will be pre-selected before medical operation. During the surgery, if the surgeon performs only the laparoscopy, the patient will be randomized. Then, the allocated procedure (with or without drain) will be carried out.
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| Manual exsufflation | Procedure | Exsufflation through the trocar opening. |
|
The site of pain will be reported to describe pain overall, but also specifically in the shoulders and/or subcostal areas and pain at trocar holes. Pain will be measured with the numerical pain assessment scale (score from 0 to 10). |
| 24 hours after surgery |
| Laparoscopic surgery specific pains, measured with a numerical pain assessment scale (score from 0 to 10) | A notebook filled in by the patient at home with a daily assessment of pain according to the numerical pain assessment scale, with a phone call from the nurse on day 7 (considering that the day of the surgery is day 0). | 7 days after surgery |
| Antalgics consumption | Qualitative description through patient notebook. | 24 hours and 7 days after surgery |
| Antalgics consumption | Quantitative description through patient notebook. | 24 hours and 7 days after surgery |
| Adverse events (AE) (grade ≥III Clavien-Dindo classification) | Safety procedure will be describe through adverse events notification potentially related to the procedure and their grade (total amount of AE, maximal grade of AE per patient). | 30 days after surgery |
| Evaluate the impact of the evaluated procedure on the hospitalisation duration | Impact of the peritoneal gas aspiration technique on the hospitalisation duration for patient with ambulatory surgery. | Through the study patient participation, an average of 2 months |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |