Micro-laparoscopy and Single-port Hysterectomy

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.

Conditions

• Pain, Postoperative

Interventions

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.

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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart

  lead OTHER

Principal Investigators

• Francesco Fanfani, MD · Catholic University of the Sacred Heart

• Anna Fagotti, PhD · Catholic University of the Sacred Heart

• Maria L Gagliardi, MD · Catholic University of the Sacred Heart

• Giorgia Monterossi, MD · Catholic University of the Sacred Heart

• Cristiano Rossitto, MD · Catholic University of the Sacred Heart

• Barbara Costantini, MD · Catholic University of the Sacred Heart

• Salvatore Gueli Alletti, MD · Catholic University of the Sacred Heart

• Giovanni Scambia, MD · Catholic University of the Sacred Heart

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2012-02-29

Completion

2012-05-31

Countries

• Italy

Study Locations