Hysterectomy
Conditions
Keywords
laparoscopy, hysterectomy, single-port trocar, surgical technique, trocar
Brief summary
The main objective of the study is the comparison of the effective duration of hospitalization following laparoscopic hysterectomy via a single-port peri-umbilical technique versus an conventional multi-port technique.
Detailed description
The secondary objectives are to compare the following between the two arms of the study: 1. the difference between the real discharge date and the theoretical discharge date 2. measures related to intraoperative bleeding 3. operating time 4. postoperative pain 5. quality of life 6. abdominal wall complication rates 7. rates of further surgery and rehospitalization 8. use of material resources in the operating room 9. average costs of hospital stay 10. Costs of rehospitalization at 1 year 11. Indirect costs
Interventions
PROCEDURESingle-port, peri-umbilical hysterectomy
Patients in this arm have a hysterectomy via a single-port peri-umbilical laparoscopic surgical technique.
PROCEDUREMulti-port hysterectomy
Patients in this arm have a hysterectomy via a conventional multi-port laparoscopic surgical technique.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must have given her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is available for 12 months of follow-up * The patient is declared fit by the anesthetist for an intervention by laparoscopy
Exclusion criteria
* The patient is not available for 12 months of follow-up * The patient is participating in another study or is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient is not insured or beneficiary of a health insurance plan * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient cannot read French * Patient with a history of pelvic radiotherapy * Patient with a history of pelvic surgery or serious risk of major adhesions * The patient is pregnant * Contraindications for anesthesia for either surgical technique * Promontofixation or lymphadenectomy * No associated procedure other than morcellation or vaginal suture for extracting the hysterectomy specimen, unilateral or bilateral oophorectomy * The patient has a known or suspected allergy to polyurethane * Extended hysterectomy for neoplastic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of hospital stay in hours | Maximum 1 month (usually 3 to 5 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding/fluid loss: Difference between lavage fluids and aspiration fluids | Day 0 (during surgery) | — |
| Change in hemoglobin measure | Day 3 versus baseline | — |
| Change in hematocrit measure | Day 3 versus baseline | — |
| Surgical time, from first incision to closing | Day 0 (during surgery) | — |
| Visual analog scale for pain | 2 hours after end of surgery (Day 0) | — |
| Questionnaire SF 36 | baseline | Quality of Life |
| Complication rate | Day 1 | Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation |
| Difference in hours between real discharge time and theoretical discharge time | 4 weeks | Criteria for theoretical hospital discharge: * Visual analog scale for pain \< 2 under stage 1 antalgics * No nausea, no vomiting * Resumption of transit, liquid and solid food * Capable of getting up, moving and going to the bathroom alone * Apyrexia |
| Surgical conversion rate | Day 0 (during surgery) | — |
| Trocar site infection rate | 4 weeks | — |
| Presence/absence of complications according to Clavien scale | Day 1 | — |
| Inventory of reusable material in the operating room and related costs. | Day 0 (after surgery) | — |
| Estimatin of indirect costs | 4 weeks | — |
| Estimation of direct costs | 12 months | — |
| Re-intervention/hospitalisation rate | 12 months | — |
Countries
France
Outcome results
None listed