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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
7
Patients in this arm have a hysterectomy via a single-port peri-umbilical laparoscopic surgical technique.
Patients in this arm have a hysterectomy via a conventional multi-port laparoscopic surgical technique.
APHM - Hôpital de la Conception
Marseille, France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
CHU de Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, France
Length of hospital stay in hours
Time frame: Maximum 1 month (usually 3 to 5 days)
Difference in hours between real discharge time and theoretical discharge time
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
Time frame: 4 weeks
Bleeding/fluid loss: Difference between lavage fluids and aspiration fluids
Time frame: Day 0 (during surgery)
Change in hemoglobin measure
Time frame: Day 3 versus baseline
Change in hematocrit measure
Time frame: Day 3 versus baseline
Surgical time, from first incision to closing
Time frame: Day 0 (during surgery)
Visual analog scale for pain
Time frame: 2 hours after end of surgery (Day 0)
Visual analog scale for pain
Time frame: 3 times per day during hospitalisation (expected maximum of 3 to 5 days)
Questionnaire SF 36
Quality of Life
Time frame: baseline
Questionnaire SF 36
Quality of Life
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 4 weeks
Complication rate
Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation
Time frame: Day 1
Complication rate
Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation
Time frame: 4 weeks
Complication rate
Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation
Time frame: 12 months
Re-intervention/hospitalisation rate
Time frame: 12 months
Surgical conversion rate
Time frame: Day 0 (during surgery)
Trocar site infection rate
Time frame: 4 weeks
Presence/absence of complications according to Clavien scale
Time frame: Day 1
Presence/absence of complications according to Clavien scale
Time frame: 12 months
Inventory of reusable material in the operating room and related costs.
Time frame: Day 0 (after surgery)
Estimatin of indirect costs
Time frame: 4 weeks
Estimation of direct costs
Time frame: 12 months
Questionnaire SF 36
Quality of Life
Time frame: 12 months