Symptoms and General Pathology

All Conditions

Nervous System Diseases

Pain, Postoperative

Pain

Postoperative Complications

Neurologic Manifestations

Hematinics

All Drugs and Chemicals

Liver Extracts

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.

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.

A 10 mm suction drain is placed through a trocar in the right hypochondrium (liver).

Drain

Manual exsufflation

Fabrice NARDUCCI, PhD

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)

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.

Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery

Drain-Exsu: Phase III Trial Assessing the Effect of Peritoneal Gas Drain on Postoperative Pain in Gynecologic Minimally Invasive Surgery

Comparison on portion of patients with significative early pain linked to the laparoscopic surgery, between the two groups (Chi-2 tests).

The maximum score pain will be evaluated by the mean difference between each group (Student or Mann-Whitney tests).

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).

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).

Qualitative description through patient notebook.

Quantitative description through patient notebook.

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).

Impact of the peritoneal gas aspiration technique on the hospitalisation duration for patient with ambulatory surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery	NCT04974125	Gynaecologic Ca...	Drain Manual exsuffla...	18 Years -	Centre Oscar Lambret
Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery	NCT04974125	Gynaecologic Ca...	Drain Manual exsuffla...	18 Years -	Centre Oscar Lambret

Spots Global Cancer Trial Database for manual exsufflation