Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy

Cervical Cancer Clinical Trial

Official title:

Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524756
• Other study ID #: LNS-RH
• Status: Completed
• Phase: N/A
• First received: August 12, 2015
• Last updated: March 2, 2018
• Start date: November 2014
• Est. completion date: November 2016

Study information

• Verified date: March 2018
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess:

1. Evaluation of the feasibility of laparoscopic nerve sparing radical hysterectomy type III/C1 as regard surgical technique, blood loss and operative time.

2. Evaluate patients' outcome as regard bladder function.

in order to preserve the function of the bladder and the rectum, it is necessary to modify the traditional procedures, so as to identify the precise anatomical information directing the technique for optimal preservation of bladder function at the time of radical hysterectomy.

The laparoscopic technique offers several well-known advantages. Under the magnified view of the laparoscope, the anatomy can be clearly visualized to allow for the meticulous and precise dissection of the para-cervical structures and areolar tissue, including the blood vessels and the nerves.

Laparoscopic identification (neurolysis) of the inferior hypogastric nerve and inferior hypogastric plexus is a feasible procedure for trained laparoscopic surgeons who have a good knowledge not only of the retroperitoneal anatomy but also of the pelvic neuro-anatomy as this qualification could prohibit long-term bladder and voiding dysfunction during nerve-sparing radical hysterectomy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age > 18 years.

2. Karnofsky > 80, or American Society of anaethesiology (ASA) I-II

3. Stage IA2-IB1-IB2-IIA1-IIA2-IIB cervical cancer according to FIGO (International Federation of Gynecology and Obstetrics) staging.

4. Stage II, III endometrial cancer

Exclusion Criteria:

1. Non Invasive Cancer

2. Pregnancy

3. Bladder dysfunction detected prior to surgery.

4. Previous pelvic lymphadenectomy.

5. Tumour recurrence

6. Incomplete surgery, unresectable lesion.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• laparoscopic nerve-sparing radical hysterectomy-type III/C1

• laparoscopic radical hysterectomy (type III/C2).

Locations

Country	Name	City	State
Italy	Largo Agostino Gemelli	Roma	RM

Sponsors (2)

Lead Sponsor	Collaborator
Osama Mohammad Ali ElDamshety	Catholic University of the Sacred Heart

Countries where clinical trial is conducted

Egypt,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome of laparoscopic nerve sparing radical hysterectomy type III/C1	Duration of postoperative catheterization untill PVR urine volume is less than 100 ml	1 month
Secondary	Intraoperative complications	intraoperative complications	During Surgery
Secondary	Blood loss	Amount of blood intraoperative blood loss in ml. units	Day of surgery
Secondary	Operative time	Minutes for the surgical intervention	Day of surgery
Secondary	Early postoperative complication	Occurence of early postoperative complication within 30 days of operation	30 days
Secondary	Late postoperative complication	complications related to surgery more than 30 days postoperative	more than 30 days postoperative
Secondary	Bladder training exercise	Removal of urinary catheter on the 3rd day postoperative without prior bladder training exercise and measurement of PVR urine volume	1 month