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Is the Anterior Superior Iliac Spine a Useful Landmark at Laparoscopy?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Royal Free Hampstead NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal Free Hampstead NHS Trust
ClinicalTrials.gov Identifier:
NCT01093430
First received: March 23, 2010
Last updated: March 24, 2010
Last verified: March 2010

March 23, 2010
March 24, 2010
September 2009
September 2011   (final data collection date for primary outcome measure)
Symmetry of lateral laparoscopic ports [ Time Frame: On the completion of laparoscopy and before the general anaesthetic is reversed ] [ Designated as safety issue: No ]
The precise location in the horizontal and vertical planes of the right and left lateral port sites will be measured to assess port symmetry.
Same as current
Complete list of historical versions of study NCT01093430 on ClinicalTrials.gov Archive Site
Neuropathy [ Time Frame: Before, immediately after and 2 weeks after gynaecological surgery ] [ Designated as safety issue: No ]
Evidence of ilio-hypogastric and ilio-inguinal neuropathy will be sought at the above time frames.
Same as current
Not Provided
Not Provided
 
Is the Anterior Superior Iliac Spine a Useful Landmark at Laparoscopy?
Anterior Superior Iliac Spine - A Useful Surface Anatomical Landmark for Safe and Symmetric Accessory Laparoscopic Port Entry

The purpose of this study is to study port symmetry and the incidence of anterior abdominal wall neuropathy associated with gynaecological surgery.

We plan to study patients undergoing gynaecological laparoscopy. Patients will be randomized to two techniques for determining where to position the right and left lateral laparoscopic ports, and port symmetry will be assessed at the end of surgery. We also plan to study patients undergoing any type of gynaecological surgery to determine the incidence of sensory neuropathy involving the lower abdomen according to the route of surgery.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Surgical Techniques
  • Laparoscopy
  • Procedure: Anterior superior iliac spine
    The position of the right and left laparoscopic port sites will be determined by palpation of the nearby anterior superior iliac spine of the pelvic bone.
    Other Name: Bony landmark
  • Procedure: Control
    The position of the right and left laparoscopic port sites will be determined by visual inspection of the anterior abdominal wall.
    Other Name: Visual
  • Experimental: Anterior superior iliac spine
    The position of the right and left laparoscopic port sites will be determined by palpation of the nearby anterior superior iliac spine of the pelvic bone.
    Intervention: Procedure: Anterior superior iliac spine
  • Active Comparator: Control
    The position of the right and left laparoscopic port sites will be determined by visual inspection of the anterior abdominal wall.
    Intervention: Procedure: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Due to undergo elective gynaecological surgery, including laparoscopy

Exclusion Criteria:

  • Previous laparoscopy
  • Junior intern as primary surgeon
Female
20 Years to 55 Years
No
Contact: Adam Magos, MD FRCOG 020 7794 0500 ext 33863 a.magos@medsch.ucl.ac.uk
United Kingdom
 
NCT01093430
AM2009/1
No
Dr. Adam Magos,. Consultant Gynaecologist/Honorary Senior Lecturer, Royal Free Hospital, Hampstead, London NW3 2QG, UK
Royal Free Hampstead NHS Trust
Not Provided
Principal Investigator: Adam Magos, MD FRCOG Royal Free Hamsptead NHS Trust
Royal Free Hampstead NHS Trust
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP