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OpenTrials
Completed

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Al Mansurah, Dakahlia Governorate, Egypt

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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 nerve-sparing radical hysterectomy-type III/C1

Procedure

laparoscopic radical hysterectomy (type III/C2).

Procedure

Primary outcomes

  1. 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

  1. Intraoperative complications

    Time frame: During Surgery

    intraoperative complications

  2. Blood loss

    Time frame: Day of surgery

    Amount of blood intraoperative blood loss in ml. units

  3. Operative time

    Time frame: Day of surgery

    Minutes for the surgical intervention

  4. Early postoperative complication

    Time frame: 30 days

    Occurence of early postoperative complication within 30 days of operation

  5. Late postoperative complication

    Time frame: more than 30 days postoperative

    complications related to surgery more than 30 days postoperative

  6. 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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