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

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Hysterectomy

Treatments: Procedure: Single-port, peri-umbilical hysterectomy; Procedure: Multi-port hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01830738

LOCAL/2012/VL-03

2012-A01054-36 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 7 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7 participants in 2 patient groups

Peri-umbilical single-port

Experimental group

Description:

Patients in this arm have a hysterectomy via a single-port peri-umbilical laparoscopic surgical technique. Intervention: Single-port, peri-umbilical hysterectomy

Treatment:

Procedure: Single-port, peri-umbilical hysterectomy

Multi-port

Active Comparator group

Description:

Patients in this arm have a hysterectomy via a conventional multi-port laparoscopic surgical technique. Intervention: Multi-port hysterectomy

Treatment:

Procedure: Multi-port hysterectomy