Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group (A)

laparoscopic nerve sparing radical hysterectomy type III/C1

Group Type ACTIVE_COMPARATOR

laparoscopic nerve-sparing radical hysterectomy-type III/C1

Intervention Type PROCEDURE

Group (B)

laparoscopic radical hysterectomy type III/C2

Group Type ACTIVE_COMPARATOR

laparoscopic radical hysterectomy (type III/C2).

Intervention Type PROCEDURE

Interventions

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laparoscopic nerve-sparing radical hysterectomy-type III/C1

Intervention Type PROCEDURE

laparoscopic radical hysterectomy (type III/C2).

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No