Laparoscopic Hysterectomy Via a Single Port, Peri-umbilical Technique Versus a Conventional Laparoscopic Technique

Study Overview
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Brief Summary
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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.

Detailed Description
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The secondary objectives are to compare the following between the two arms of the study: the difference between the real discharge date and the theoretical discharge date measures related to intraoperative bleeding operating time postoperative pain quality of life abdominal wall complication rates rates of further surgery and rehospitalization use of material resources in the operating room average costs of hospital stay Costs of rehospitalization at 1 year Indirect costs

Official Title
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Laparoscopic Hysterectomy Via a Single Port, Peri-umbilical Technique Versus a Conventional Laparoscopic Technique : a Prospective, Randomized, Multicenter Study Evaluating the Length of Hospital Stay

Conditions
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Hysterectomy

Intervention / Treatment
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* Procedure: Single-port, peri-umbilical hysterectomy
* Procedure: Multi-port hysterectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peri-umbilical single-port<br>Patients in this arm have a hysterectomy via a single-port peri-umbilical laparoscopic surgical technique. Intervention: Single-port, peri-umbilical hysterectomy | Procedure: Single-port, peri-umbilical hysterectomy<br>* Patients in this arm have a hysterectomy via a single-port peri-umbilical laparoscopic surgical technique.<br>|
| Active Comparator: Multi-port<br>Patients in this arm have a hysterectomy via a conventional multi-port laparoscopic surgical technique. Intervention: Multi-port hysterectomy | Procedure: Multi-port hysterectomy<br>* Patients in this arm have a hysterectomy via a conventional multi-port laparoscopic surgical technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay in hours |  | Maximum 1 month (usually 3 to 5 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy, hysterectomy, single-port trocar, surgical technique, trocar