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

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ClinicalTrials.gov Identifier: NCT01666483
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : August 16, 2012
Sponsor:
Information provided by (Responsible Party):
Prof. Giovanni Scambia, Catholic University of the Sacred Heart

Brief Summary:
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 or disease Intervention/treatment Phase
Pain, Postoperative Procedure: micro-laparoscopy Procedure: Laparoendoscopic single site surgery Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Micro-laparoscopic Versus Single-port Total Hysterectomy: a Randomized Trial.
Study Start Date : May 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Post-operative pain [ Time Frame: within 8 hours after surgery ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: August 16, 2012
Last Verified: August 2012

Keywords provided by Prof. Giovanni Scambia, Catholic University of the Sacred Heart:
hysterectomy
single-port
micro-laparoscopy

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms