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

NCT01830738 | Terminated

• 2 other identifiers: LOCAL/2012/VL-032012-A01054-36
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

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.

Conditions

Hysterectomy

Keywords

laparoscopy; hysterectomy; single-port trocar; surgical technique; trocar

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay in hours

  Maximum 1 month (usually 3 to 5 days)

Secondary Outcomes (21)

• Difference in hours between real discharge time and theoretical discharge time

  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)

Study Arms (2)

Peri-umbilical single-port

EXPERIMENTAL

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

Multi-port

ACTIVE COMPARATOR

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

Procedure: Multi-port hysterectomy

Interventions

Single-port, peri-umbilical hysterectomy PROCEDURE

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

Peri-umbilical single-port

Multi-port hysterectomy PROCEDURE

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

Multi-port

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is not available for 12 months of follow-up
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (3)

APHM - Hôpital de la Conception

Marseille, 13385, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

CHU de Saint Etienne - Hôpital Nord

Saint-Priest-en-Jarez, 42270, France

Location

Study Officials

• Vincent Letouzey, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: April 12, 2013
• Study Start: February 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: April 1, 2015
• Last Updated: October 22, 2015

Record last verified: 2015-10

Locations

FR (3)