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

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

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.

Study Overview

• Status: Terminated
• Conditions: Hysterectomy
• Intervention / Treatment: Procedure: Single-port, peri-umbilical hysterectomy; Procedure: Multi-port hysterectomy

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13385
    • APHM - Hôpital de la Conception
  • Nîmes Cedex 9, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau
  • Saint-Priest en Jarez, France, 42270
    • CHU de Saint Etienne - Hopital Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: April 10, 2013
• First Submitted That Met QC Criteria: April 11, 2013
• First Posted (Estimate): April 12, 2013

Study Record Updates

• Last Update Posted (Estimate): October 22, 2015
• Last Update Submitted That Met QC Criteria: October 21, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: laparoscopy; hysterectomy; surgical technique; trocar; single-port trocar
• Other Study ID Numbers: LOCAL/2012/VL-03; 2012-A01054-36 (Other Identifier: RCB number)