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

Hysterectomy Clinical Trial

— HOT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01830738
• Other study ID #: LOCAL/2012/VL-03
• Secondary ID: 2012-A01054-36
• Status: Terminated
• Phase: N/A
• First received: April 10, 2013
• Last updated: October 21, 2015
• Start date: February 2014
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Procedure:
• Single-port, peri-umbilical hysterectomy
Patients in this arm have a hysterectomy via a single-port peri-umbilical laparoscopic surgical technique.
• Multi-port hysterectomy
Patients in this arm have a hysterectomy via a conventional multi-port laparoscopic surgical technique.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay in hours		Maximum 1 month (usually 3 to 5 days)	No
Secondary	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	No
Secondary	Bleeding/fluid loss: Difference between lavage fluids and aspiration fluids		Day 0 (during surgery)	Yes
Secondary	Change in hemoglobin measure		Day 3 versus baseline	Yes
Secondary	Change in hematocrit measure		Day 3 versus baseline	Yes
Secondary	Surgical time, from first incision to closing		Day 0 (during surgery)	Yes
Secondary	Visual analog scale for pain		2 hours after end of surgery (Day 0)	Yes
Secondary	Visual analog scale for pain		3 times per day during hospitalisation (expected maximum of 3 to 5 days)	Yes
Secondary	Questionnaire SF 36	Quality of Life	baseline	No
Secondary	Questionnaire SF 36	Quality of Life	4 weeks	No
Secondary	Complication rate	Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation	Day 1	Yes
Secondary	Complication rate	Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation	4 weeks	Yes
Secondary	Complication rate	Includes: hematomas around trocar sites; localized care for trocar infection or hematoma; surgery for trocar site herniation	12 months	Yes
Secondary	Re-intervention/hospitalisation rate		12 months	Yes
Secondary	Surgical conversion rate		Day 0 (during surgery)	Yes
Secondary	Trocar site infection rate		4 weeks	Yes
Secondary	Presence/absence of complications according to Clavien scale		Day 1	Yes
Secondary	Presence/absence of complications according to Clavien scale		12 months	Yes
Secondary	Inventory of reusable material in the operating room and related costs.		Day 0 (after surgery)	No
Secondary	Estimatin of indirect costs		4 weeks	No
Secondary	Estimation of direct costs		12 months	No
Secondary	Questionnaire SF 36	Quality of Life	12 months	No