Gynaecologic Cancer Clinical Trial
— DRAIN-EXSUOfficial title:
Drain-Exsu: Phase III Trial Assessing the Effect of Peritoneal Gas Drain on Postoperative Pain in Gynecologic Minimally Invasive Surgery
| Verified date | December 2023 |
| Source | Centre Oscar Lambret |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 202 |
| Est. completion date | December 11, 2023 |
| Est. primary completion date | December 11, 2023 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Age = 18 ans ; - Woman who underwent laparoscopic or robotised laparoscopic surgery in peritoneal cavity (benign or malignant gynaecological affection) ; - Planned ambulatory surgery - Patient willing and able to be treated and followed according the protocol during the trial ; - Patient covered by the French "Social Security" regime ; - Effective contraception for reproductive age patients ; - Signed written informed consent before surgery Per-operatory eligibility criterion : - No conversion from laparoscopic surgery to laparotomy surgery Exclusion Criteria: - Extra-peritoneal surgery scheduled ( example : aortic dissection) ; - Upper-abdomen surgery (example : liver, gall bladder) ; - History of shoulders pains prior to surgery (the assessment must be carried out within a period of 30 days before the surgery) ; - Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons) - Person under guardianship - Pregnant or breastfeeding woman Non eligibility criterion known during the operation : - Conversion from laparoscopic surgery to laparotomy surgery |
| Country | Name | City | State |
|---|---|---|---|
| France | Fabrice NARDUCCI | Lille |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Oscar Lambret |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | 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). |
24 hours after surgery | |
| Secondary | 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 | |
| Secondary | Antalgics consumption | Qualitative description through patient notebook. | 24 hours and 7 days after surgery | |
| Secondary | Antalgics consumption | Quantitative description through patient notebook. | 24 hours and 7 days after surgery | |
| Secondary | 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 | |
| Secondary | 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 |