Clinical trial NCT02524756: Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy
Official title: Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: nerve sparing radical hysterectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
First posted: 2015-08-17
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Functional outcome of laparoscopic nerve sparing radical hysterectomy type III/C1
timeFrame: 1 month
Secondary outcomes:
measure: Intraoperative complications
timeFrame: During Surgery
measure: Blood loss
timeFrame: Day of surgery
measure: Operative time
timeFrame: Day of surgery
measure: Early postoperative complication
timeFrame: 30 days
measure: Late postoperative complication
timeFrame: more than 30 days postoperative
measure: Bladder training exercise
timeFrame: 1 month
Other outcomes:
Locations:
city: Mansourah
country: Egypt
state: Dakahlia
city: Roma
country: Italy
facility: Largo Agostino Gemelli
state: RM
Study officials:
affiliation: Assistant Lecturer of surgical oncology, Mansoura universitry
name: Khaled Gaballa, MS.c.
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of surgical oncology department, Mansoura oncology centre, Mansoura university
name: Adel Taha Denewar, M.D., Ph.D
role: STUDY_CHAIR
affiliation: Head of the Department for Woman and Unborn Life Health Care- Catholic University of the Sacred Heart- Rome, Italy
name: Giovanni Scambia, M.D.,Ph.D
role: STUDY_DIRECTOR
affiliation: Department of Gynecologic Oncology,Catholic University of the Sacred Heart,Rome,Italy
name: Valerio Gallotta, M.D.
role: STUDY_DIRECTOR
References: