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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01830738
First received: April 10, 2013
Last updated: May 9, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Hysterectomy
Procedure: Single-port, peri-umbilical hysterectomy
Procedure: Multi-port hysterectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Length of hospital stay in hours [ Time Frame: Maximum 1 month (usually 3 to 5 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in hours between real discharge time and theoretical discharge time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    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

  • Bleeding/fluid loss: Difference between lavage fluids and aspiration fluids [ Time Frame: Day 0 (during surgery) ] [ Designated as safety issue: Yes ]
  • Change in hemoglobin measure [ Time Frame: Day 3 versus baseline ] [ Designated as safety issue: Yes ]
  • Change in hematocrit measure [ Time Frame: Day 3 versus baseline ] [ Designated as safety issue: Yes ]
  • Surgical time, from first incision to closing [ Time Frame: Day 0 (during surgery) ] [ Designated as safety issue: Yes ]
  • Visual analog scale for pain [ Time Frame: 2 hours after end of surgery (Day 0) ] [ Designated as safety issue: Yes ]
  • Visual analog scale for pain [ Time Frame: 3 times per day during hospitalisation (expected maximum of 3 to 5 days) ] [ Designated as safety issue: Yes ]
  • Questionnaire SF 36 [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Quality of Life

  • Questionnaire SF 36 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Quality of Life

  • Complication rate [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation

  • Complication rate [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation

  • Complication rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation

  • Re-intervention/hospitalisation rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Surgical conversion rate [ Time Frame: Day 0 (during surgery) ] [ Designated as safety issue: Yes ]
  • Trocar site infection rate [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Presence/absence of complications according to Clavien scale [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Presence/absence of complications according to Clavien scale [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Inventory of reusable material in the operating room and related costs. [ Time Frame: Day 0 (after surgery) ] [ Designated as safety issue: No ]
  • Estimatin of indirect costs [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Estimation of direct costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Questionnaire SF 36 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Quality of Life


Estimated Enrollment: 140
Study Start Date: February 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01830738

Contacts
Contact: Vincent Letouzey, MD +33.(0)4.66.68.32.16 vincent.letouzey@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 9, France, 30029
Principal Investigator: Vincent Letouzey, MD         
Sub-Investigator: Olivier Pouget, MD         
Sub-Investigator: Florent Masia, MD         
Sub-Investigator: Renaud de Tayrac, MD, PhD         
Sub-Investigator: Pierre Marès, MD, PhD         
Sub-Investigator: Mélanie Cayrac, MD         
Principal Investigator: Céline Chauleur, MD, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Vincent Letouzey, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01830738     History of Changes
Other Study ID Numbers: LOCAL/2012/VL-03, 2012-A01054-36
Study First Received: April 10, 2013
Last Updated: May 9, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
laparoscopy
hysterectomy
single-port trocar
surgical technique
trocar

ClinicalTrials.gov processed this record on October 19, 2014