Micro-laparoscopy and Single-port Hysterectomy

NCT01666483 | Completed DMC

• 1 other identifier: P/473/CE/2011
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

hysterectomy; single-port; micro-laparoscopy

Outcome Measures

Primary Outcomes (1)

• Post-operative pain

  within 8 hours after surgery

Study Arms (2)

micro-laparoscopy

ACTIVE COMPARATOR

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

laparoendoscopic single site surgery

ACTIVE COMPARATOR

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

Interventions

micro-laparoscopy PROCEDURE

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.

micro-laparoscopy

Laparoendoscopic single site surgery PROCEDURE

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.

laparoendoscopic single site surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pelvic organ prolapse greater than grade I

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Francesco Fanfani

Rome, Rome, 00168, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: August 16, 2012
• Study Start: May 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 16, 2012

Record last verified: 2012-08

Locations

IT (1)