Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy

Osama Mohammad Ali ElDamshety

Status: Completed

Conditions: Cervical Cancer

Treatments: Procedure: laparoscopic nerve-sparing radical hysterectomy-type III/C1; Procedure: laparoscopic radical hysterectomy (type III/C2).

Study type: Interventional

Funder types: Other

Identifiers

NCT02524756

LNS-RH

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Group (A)

Active Comparator group

Description:

laparoscopic nerve sparing radical hysterectomy type III/C1

Treatment:

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

Group (B)

Active Comparator group

Description:

laparoscopic radical hysterectomy type III/C2

Treatment:

Procedure: laparoscopic radical hysterectomy (type III/C2).