Clinical trial NCT01830738: Laparoscopic Hysterectomy Via a Single Port, Peri-umbilical Technique Versus a Conventional Laparoscopic Technique
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hysterectomy
Keywords: laparoscopy
hysterectomy
single-port trocar
surgical technique
trocar
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-04-12
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Length of hospital stay in hours
timeFrame: Maximum 1 month (usually 3 to 5 days)
Secondary outcomes:
measure: Difference in hours between real discharge time and theoretical discharge time
timeFrame: 4 weeks
measure: Bleeding/fluid loss: Difference between lavage fluids and aspiration fluids
timeFrame: Day 0 (during surgery)
measure: Change in hemoglobin measure
timeFrame: Day 3 versus baseline
measure: Change in hematocrit measure
timeFrame: Day 3 versus baseline
measure: Surgical time, from first incision to closing
timeFrame: Day 0 (during surgery)
measure: Visual analog scale for pain
timeFrame: 2 hours after end of surgery (Day 0)
measure: Visual analog scale for pain
timeFrame: 3 times per day during hospitalisation (expected maximum of 3 to 5 days)
measure: Questionnaire SF 36
timeFrame: baseline
measure: Questionnaire SF 36
timeFrame: 4 weeks
measure: Complication rate
timeFrame: Day 1
measure: Complication rate
timeFrame: 4 weeks
measure: Complication rate
timeFrame: 12 months
measure: Re-intervention/hospitalisation rate
timeFrame: 12 months
measure: Surgical conversion rate
timeFrame: Day 0 (during surgery)
measure: Trocar site infection rate
timeFrame: 4 weeks
measure: Presence/absence of complications according to Clavien scale
timeFrame: Day 1
measure: Presence/absence of complications according to Clavien scale
timeFrame: 12 months
measure: Inventory of reusable material in the operating room and related costs.
timeFrame: Day 0 (after surgery)
measure: Estimatin of indirect costs
timeFrame: 4 weeks
measure: Estimation of direct costs
timeFrame: 12 months
measure: Questionnaire SF 36
timeFrame: 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: APHM - Hôpital de la Conception
city: Nîmes Cedex 9
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
city: Saint-Priest en Jarez
country: France
facility: CHU de Saint Etienne - Hôpital Nord
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Vincent Letouzey, MD
role: PRINCIPAL_INVESTIGATOR
References: