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

Not Applicable

Terminated

• Conditions: Hysterectomy

• Registration Number: NCT01830738
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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

Study Timeline

• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-12
• Study Start: 2014-02
• Primary Completion: 2014-08
• Study Completion: 2015-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-21
• Last Update Posted: 2015-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Length of hospital stay in hours	Maximum 1 month (usually 3 to 5 days)

Secondary Outcome Measures

Name	Time	Method
Change in hemoglobin measure	Day 3 versus baseline
Change in hematocrit measure	Day 3 versus baseline
Difference in hours between real discharge time and theoretical discharge time	4 weeks	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
Surgical conversion rate	Day 0 (during surgery)
Estimatin of indirect costs	4 weeks
Bleeding/fluid loss: Difference between lavage fluids and aspiration fluids	Day 0 (during surgery)
Surgical time, from first incision to closing	Day 0 (during surgery)
Visual analog scale for pain	3 times per day during hospitalisation (expected maximum of 3 to 5 days)
Presence/absence of complications according to Clavien scale	12 months
Complication rate	12 months	Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation
Re-intervention/hospitalisation rate	12 months
Inventory of reusable material in the operating room and related costs.	Day 0 (after surgery)
Estimation of direct costs	12 months
Questionnaire SF 36	12 months	Quality of Life
Trocar site infection rate	4 weeks

Trial Locations

Locations (3)

APHM - Hôpital de la Conception; 🇫🇷 Marseille, France

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France

CHU de Saint Etienne - Hôpital Nord; 🇫🇷 Saint-Priest en Jarez, France