Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Procedure: laparoscopic nerve-sparing radical hysterectomy-type III/C1; Procedure: laparoscopic radical hysterectomy (type III/C2).

• Registration Number: NCT02524756
• Lead Sponsor: Osama Mohammad Ali ElDamshety

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-08-12
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-17
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-02
• Last Update Posted: 2018-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (A)	laparoscopic nerve-sparing radical hysterectomy-type III/C1	laparoscopic nerve sparing radical hysterectomy type III/C1
Group (B)	laparoscopic radical hysterectomy (type III/C2).	laparoscopic radical hysterectomy type III/C2

Primary Outcome Measures

Name	Time	Method
Functional outcome of laparoscopic nerve sparing radical hysterectomy type III/C1	1 month	Duration of postoperative catheterization untill PVR urine volume is less than 100 ml

Secondary Outcome Measures

Name	Time	Method
Intraoperative complications	During Surgery	intraoperative complications
Operative time	Day of surgery	Minutes for the surgical intervention
Late postoperative complication	more than 30 days postoperative	complications related to surgery more than 30 days postoperative
Bladder training exercise	1 month	Removal of urinary catheter on the 3rd day postoperative without prior bladder training exercise and measurement of PVR urine volume
Blood loss	Day of surgery	Amount of blood intraoperative blood loss in ml. units
Early postoperative complication	30 days	Occurence of early postoperative complication within 30 days of operation

Trial Locations

Locations (1)

Largo Agostino Gemelli; 🇮🇹 Roma, RM, Italy