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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01054-36 | Other Identifier | RCB number |
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Inclusion curve too poor.
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peri-umbilical single-port | Experimental | Patients in this arm have a hysterectomy via a single-port peri-umbilical laparoscopic surgical technique. Intervention: Single-port, peri-umbilical hysterectomy |
|
| Multi-port | Active Comparator | Patients in this arm have a hysterectomy via a conventional multi-port laparoscopic surgical technique. Intervention: Multi-port hysterectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-port, peri-umbilical hysterectomy | Procedure | Patients in this arm have a hysterectomy via a single-port peri-umbilical laparoscopic surgical technique. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay in hours | Maximum 1 month (usually 3 to 5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in hours between real discharge time and theoretical discharge time | Criteria for theoretical hospital discharge:
| 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Letouzey, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHM - Hôpital de la Conception | Marseille | 13385 | France | |||
| CHU de Nîmes - Hôpital Universitaire Carémeau |
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| Multi-port hysterectomy | Procedure | Patients in this arm have a hysterectomy via a conventional multi-port laparoscopic surgical technique. |
|
| 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) |
| Visual analog scale for pain | 3 times per day during hospitalisation (expected maximum of 3 to 5 days) |
| Questionnaire SF 36 | Quality of Life | baseline |
| Questionnaire SF 36 | Quality of Life | 4 weeks |
| Complication rate | Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation | Day 1 |
| Complication rate | Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation | 4 weeks |
| Complication rate | Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation | 12 months |
| Re-intervention/hospitalisation rate | 12 months |
| Surgical conversion rate | Day 0 (during surgery) |
| Trocar site infection rate | 4 weeks |
| Presence/absence of complications according to Clavien scale | Day 1 |
| Presence/absence of complications according to Clavien scale | 12 months |
| 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 |
| Questionnaire SF 36 | Quality of Life | 12 months |
| Nîmes |
| 30029 |
| France |
| CHU de Saint Etienne - Hôpital Nord | Saint-Priest-en-Jarez | 42270 | France |