Fabrice NARDUCCI
Lille, 59020, France
NCT Number: NCT04974125
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Lille, 59020, France
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 :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Per-operatory eligibility criterion :
Exclusion criteria
Non eligibility criterion known during the operation :
A 10 mm suction drain is placed through a trocar in the right hypochondrium (liver).
Exsufflation through the trocar opening.
Time frame: During the 24 hours after surgery
Comparison on portion of patients with significative early pain linked to the laparoscopic surgery, between the two groups (Chi-2 tests).
Time frame: 24 hours after surgery
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
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: 7 days after surgery
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: 24 hours and 7 days after surgery
Qualitative description through patient notebook.
Time frame: 24 hours and 7 days after surgery
Quantitative description through patient notebook.
Time frame: 30 days after surgery
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: Through the study patient participation, an average of 2 months
Impact of the peritoneal gas aspiration technique on the hospitalisation duration for patient with ambulatory surgery.
Centre Oscar Lambret
Other
Drain-Exsu: Phase III Trial Assessing the Effect of Peritoneal Gas Drain on Postoperative Pain in Gynecologic Minimally Invasive Surgery
Acronym: DRAIN-EXSU
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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