Micro-laparoscopy and Single-port Hysterectomy (MLPS/LESS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Giovanni Scambia, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01666483
First received: May 11, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

A total of 86 patients underwent total hysterectomy. Three of them refused randomization, 34 were randomly assigned to undergo to laparoendoscopic single-site surgery (LESS) and 34 to undergo micro-laparoscopy (M-LPS).Laparoscopic hysterectomy can be safely performed by M-LPS and LESS.


Condition Intervention
Pain, Postoperative
Procedure: micro-laparoscopy
Procedure: Laparoendoscopic single site surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Micro-laparoscopic Versus Single-port Total Hysterectomy: a Randomized Trial.

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Post-operative pain [ Time Frame: within 8 hours after surgery ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: micro-laparoscopy
M-LPS hysterectomy was performed through one optical trans-umbilical 5 mm trocar and three 3 mm sovra-pubic ancillary ports. A 5 mm 0° endoscope and 3 mm laparoscopic instruments were utilized, choosing among graspers, cold scissors, suction/irrigation and bipolar coagulator.
Procedure: micro-laparoscopy
M-LPS hysterectomy was performed through one optical trans-umbilical 5 mm trocar and three 3 mm sovra-pubic ancillary ports. A 5 mm 0° endoscope and 3 mm laparoscopic instruments were utilized, choosing among graspers, cold scissors, suction/irrigation and bipolar coagulator.
Active Comparator: laparoendoscopic single site surgery
LESS hysterectomy was performed through a multi-channel single trocar inserted in the umbilicus using an open technique (1.5-2 cm cutaneous incision), as previously reported. Intra-abdominal visualization was obtained with a 0° 5-mm telescope with a flexible tip.Working straight 5-mm instruments were inserted into the remaining 2 ports, choosing among graspers, cold scissors, suction/irrigation bipolar coagulator and a multifunctional versatile laparoscopic device, which grasps, coagulates and transects simultaneously. In order to prevent clashing between instruments and surgeon's hands and to facilitate surgical manoeuvres, the combination of one 33 cm-long instrument with a 43 cm-long instrument was adopted. The umbilical fascia was closed with a figure-of-eight 0-Vicryl.
Procedure: Laparoendoscopic single site surgery
LESS hysterectomy was performed through a multi-channel single trocar inserted in the umbilicus using an open technique (1.5-2 cm cutaneous incision), as previously reported. Intra-abdominal visualization was obtained with a 0° 5-mm telescope with a flexible tip. Working straight 5-mm instruments were inserted into the remaining 2 ports, choosing among graspers, cold scissors, suction/irrigation bipolar coagulator and a multifunctional versatile laparoscopic device, which grasps, coagulates and transects simultaneously. In order to prevent clashing between instruments and surgeon's hands and to facilitate surgical manoeuvres, the combination of one 33 cm-long instrument with a 43 cm-long instrument was adopted. The umbilical fascia was closed with a figure-of-eight 0-Vicryl.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • appropriate medical status for laparoscopic surgery;
  • uterine size < 12 weeks of pregnancy;
  • no previous longitudinal major abdominal surgery.

Exclusion Criteria:

  • pelvic organ prolapse greater than grade I
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01666483

Locations
Italy
Francesco Fanfani
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Francesco Fanfani, MD Catholic University of the Sacred Heart
Principal Investigator: Anna Fagotti, PhD Catholic University of the Sacred Heart
Principal Investigator: Maria L Gagliardi, MD Catholic University of the Sacred Heart
Principal Investigator: Giorgia Monterossi, MD Catholic University of the Sacred Heart
Principal Investigator: Cristiano Rossitto, MD Catholic University of the Sacred Heart
Principal Investigator: Barbara Costantini, MD Catholic University of the Sacred Heart
Principal Investigator: Salvatore Gueli Alletti, MD Catholic University of the Sacred Heart
Principal Investigator: Giovanni Scambia, MD Catholic University of the Sacred Heart
  More Information

No publications provided

Responsible Party: Prof. Giovanni Scambia, Clinical Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01666483     History of Changes
Other Study ID Numbers: P/473/CE/2011
Study First Received: May 11, 2012
Last Updated: August 14, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Catholic University of the Sacred Heart:
hysterectomy
single-port
micro-laparoscopy

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014