Gynaecologic Cancer
Conditions
Keywords
Postoperative pain, Peritoneal gas drainage, Laparoscopic gynaecological surgery, Robotised laparoscopic gynaecological surgery
Brief summary
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.
Detailed description
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)
Interventions
PROCEDUREDrain
A 10 mm suction drain is placed through a trocar in the right hypochondrium (liver).
PROCEDUREManual exsufflation
Exsufflation through the trocar opening.
Sponsors
Centre Oscar Lambret
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal score pain, measured with a numerical pain assessment scale (score from 0 to 10) | 24 hours after surgery | The maximum score pain will be evaluated by the mean difference between each group (Student or Mann-Whitney tests). |
| Assess pain at trocar holes comparatively in the two groups | 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). |
| Laparoscopic surgery specific pains, measured with a numerical pain assessment scale (score from 0 to 10) | 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). |
| Antalgics consumption | 24 hours and 7 days after surgery | Qualitative description through patient notebook. |
| Adverse events (AE) (grade ≥III Clavien-Dindo classification) | 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). |
| Evaluate the impact of the evaluated procedure on the hospitalisation duration | 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. |
Countries
France
Contacts
STUDY_DIRECTORFabrice NARDUCCI, PhD
Centre Oscar Lambret
Outcome results
None listed