NCT Number: NCT02524756
Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy
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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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Al Mansurah, Dakahlia Governorate, Egypt
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age > 18 years.
- Karnofsky > 80, or American Society of anaethesiology (ASA) I-II
- Stage IA2-IB1-IB2-IIA1-IIA2-IIB cervical cancer according to FIGO (International Federation of Gynecology and Obstetrics) staging.
- Stage II, III endometrial cancer
Exclusion criteria
- Non Invasive Cancer
- Pregnancy
- Bladder dysfunction detected prior to surgery.
- Previous pelvic lymphadenectomy.
- Tumour recurrence
- Incomplete surgery, unresectable lesion.
Treatment and study plan
laparoscopic radical hysterectomy (type III/C2).
ProcedurePrimary outcomes
-
Functional outcome of laparoscopic nerve sparing radical hysterectomy type III/C1
Time frame: 1 month
Duration of postoperative catheterization untill PVR urine volume is less than 100 ml
Secondary outcomes
-
Intraoperative complications
Time frame: During Surgery
intraoperative complications
-
Blood loss
Time frame: Day of surgery
Amount of blood intraoperative blood loss in ml. units
-
Operative time
Time frame: Day of surgery
Minutes for the surgical intervention
-
Early postoperative complication
Time frame: 30 days
Occurence of early postoperative complication within 30 days of operation
-
Late postoperative complication
Time frame: more than 30 days postoperative
complications related to surgery more than 30 days postoperative
-
Bladder training exercise
Time frame: 1 month
Removal of urinary catheter on the 3rd day postoperative without prior bladder training exercise and measurement of PVR urine volume
Sponsors and collaborators
Lead sponsor
Osama Mohammad Ali ElDamshety
Other
Collaborators
- Catholic University of the Sacred Heart
Registry information
Important dates
- Study start
- 2014
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Aug 17, 2015
- Registry last updated
- Mar 6, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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