2D Versus 3D Radical Laparoscopic Hysterectomy for Cervical Cancer: a Prospective Randomized Trial

NCT02320578 | Completed DMC

• 1 other identifier: 3D vs 2D Cervix
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective randomized pilot study is to verify if the operative time of a Radical abdominal hysterectomy (LRH) with pelvic lymphadenectomy for early stage cervical cancer (FIGO stages IA2-IB1-IIA\<2cm) and for advanced stage cervical cancer (FIGO stages IB2-IIA\>2cm-IIB) submitted to neoadjuvant chemotherapy (NACT) with complete clinical response could be further reduced using 3D Laparoscopy (Olympus Medical Systems Corp) versus standard laparoscopy

Conditions

Uterine Cervical Neoplasms; Laparoscopic Surgical Procedures

Keywords

Neoadjuvant Chemoptherapy; Laparoscopy 3D; Cervical cancer

Outcome Measures

Primary Outcomes (1)

• Operative time for laparoscopic radical hysterectomy with pelvic lymphadenectomy

  Operative time will be calculated from the entrance in the abdominal cavity to the closure of the skin trocar accesses

  Intraoperative

Secondary Outcomes (1)

• Number of participants with intra or post operative complications

  two years

Study Arms (2)

3D Laparoscopy

EXPERIMENTAL

Laparoscopic radical hysterectomy with pelvic lymphadenectomy are performed with 3D Laparoscopic technology. A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° high-definition 3D telescope. Two additional 5 mm ports are placed under direct visualization. One more 5- mm trocar is inserted in the right mid abdomen at the level of the umbilicus. The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system.

Procedure: 3D Laparoscopy

Standard Laparoscopy

ACTIVE COMPARATOR

Laparoscopic radical hysterectomy with pelvic lymphadenectomy are performed with standard laparoscopy technology. A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° high-definition telescope. Two additional 5 mm ports are placed under direct visualization. One more 5 mm trocar is inserted in the right mid abdomen at the level of the umbilicus. The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system.

Procedure: Standard Laparoscopy

Interventions

3D Laparoscopy PROCEDURE

3D Laparoscopy approach

3D Laparoscopy

Standard Laparoscopy PROCEDURE

Standard laparoscopy approach

Standard Laparoscopy

Eligibility Criteria

• Age: Up to 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

* Age ≤ 75 years * Patient's informed consent * American Society of Anesthesiologists: \< class III or IV * No actual pregnancies or P.I.D. * No previous major abdominal surgical procedures * Early stage cervical cancer (FIGO stages IA2-IB1-IIA\<2cm) and advanced stage cervical cancer (FIGO stages IB2-IIA\>2cm-IIB) submitted to NACT with complete clinical response * No previous radiotherapy on the pelvic field * No uterine size larger than conform 10 weeks gestation

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead
• Fanfani, Francesco, M.D.: collaborator
• Fagotti, Anna, M.D.: collaborator

Study Sites (1)

Catholic University of the Sacred Heart

Rome, Italy, 00168, Italy

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Dip per la Tutela della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 19, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

IT (1)