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 : * Comparing the evolution of specific pains after laparoscopic surgery, between study groups * Description of postoperative antalgics consumption in each group * Evaluating the safety of the evaluated procedure * Evaluating the impact of the evaluated procedure on hospitalisation duration ( for patients with ambulatory surgery initially planned)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
202
A 10 mm suction drain is placed through a trocar in the right hypochondrium (liver).
Exsufflation through the trocar opening.
Fabrice NARDUCCI
Lille, France
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).
Time frame: During the 24 hours after surgery
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).
Time frame: 24 hours after surgery
Assess pain at trocar holes comparatively in the two groups
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).
Time frame: 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).
Time frame: 7 days after surgery
Antalgics consumption
Qualitative description through patient notebook.
Time frame: 24 hours and 7 days after surgery
Antalgics consumption
Quantitative description through patient notebook.
Time frame: 24 hours and 7 days after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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).
Time frame: 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.
Time frame: Through the study patient participation, an average of 2 months