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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01218-33 | Other Identifier | 2021-A01218-33 |
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During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. The surgeon will randomize the patient using RedCap computer software. The patient will then be referred either to the vNOTES group or to the laparoscopy group. The surgery will be performed by surgeons called "expert" in one of the ways first. For this, it will be necessary to have performed at least 25 hysterectomies by laparoscopy or vNOTES. The surgery will take place using the usual techniques. Per and postoperative complications will be studied and noted up to six months postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopy | Placebo Comparator | In this Arm, patient will have the traditional hysterectomy by laparoscopy. This is the type of surgery that we realize everyday. |
|
| vNOTES | Active Comparator | In this Arm, patient will have the hysterectomy by vNOTES (vaginal natural orifices Transluminal surgery). It's the new type of surgery that we want prove the no-inferiority. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopy | Procedure | The hysterectomy is performed by laparoscopy as described in the EMC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complications per or post Operative | Appearance of a per or post operative complication: bleeding, digestive or urinary sore or infection | one month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of pain | Quantification of postoperative pain: 6 hours, 24 hours, day 2, 5, 7, 14 and at one month | Until one month |
| Duration of operation | From skin opening to skin or vaginal closure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra CURINIER | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU clermont-ferrand | Clermont-Ferrand | France | ||||
| CH d'Issoire |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37642285 | Derived | Pickett CM, Seeratan DD, Mol BWJ, Nieboer TE, Johnson N, Bonestroo T, Aarts JW. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2023 Aug 29;8(8):CD003677. doi: 10.1002/14651858.CD003677.pub6. |
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| vNOTES | Procedure | The hysterectomy is performed by vNOTES as described Dr BAEKELANDT and this team. |
|
| one day |
| Assessment of quality of life | Respond to SF-36 questionnaire to assess and compare quality of life before and after surgery | Six month |
| Assessment of satisfaction | Respond to FSFI questionnaire to assess and compare sexuality before and after surgery | Six month |
| Duration of work stoppage | Patients will inquire if they needed to prolong the sick leave. | one month |
| Issoire |
| France |
| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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