Feasibility and Functional Outcome of Laparoscopic Nerve Sparing Radical Hysterectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 46
- Locations
- 2
- Primary Endpoint
- Functional outcome of laparoscopic nerve sparing radical hysterectomy type III/C1
Study Overview
Brief Summary
The aim of this study is to assess:
- Evaluation of the feasibility of laparoscopic nerve sparing radical hysterectomy type III/C1 as regard surgical technique, blood loss and operative time.
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •Bladder dysfunction detected prior to surgery.
- •Previous pelvic lymphadenectomy.
- •Tumour recurrence
- •Incomplete surgery, unresectable lesion.
Arms & Interventions
Group (A)
laparoscopic nerve sparing radical hysterectomy type III/C1
Intervention: laparoscopic nerve-sparing radical hysterectomy-type III/C1 (Procedure)
Group (B)
laparoscopic radical hysterectomy type III/C2
Intervention: laparoscopic radical hysterectomy (type III/C2). (Procedure)
Outcomes
Primary 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(During Surgery)
- Operative time(Day of surgery)
- Late postoperative complication(more than 30 days postoperative)
- Bladder training exercise(1 month)
- Blood loss(Day of surgery)
- Early postoperative complication(30 days)
Investigators
Osama Mohammad Ali ElDamshety
surgical oncology
Mansoura University