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

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ClinicalTrials.gov Identifier: NCT01093430
Recruitment Status : Unknown
Verified March 2010 by Royal Free Hampstead NHS Trust.
Recruitment status was:  Recruiting
First Posted : March 25, 2010
Last Update Posted : March 25, 2010
Sponsor:
Information provided by:
Royal Free Hampstead NHS Trust

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

Condition or disease Intervention/treatment Phase
Surgical Techniques Laparoscopy Procedure: Anterior superior iliac spine Procedure: Control Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anterior Superior Iliac Spine - A Useful Surface Anatomical Landmark for Safe and Symmetric Accessory Laparoscopic Port Entry
Study Start Date : September 2009
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Arm Intervention/treatment
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.
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

Active Comparator: Control
The position of the right and left laparoscopic port sites will be determined by visual inspection of the anterior abdominal wall.
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




Primary Outcome Measures :
  1. Symmetry of lateral laparoscopic ports [ Time Frame: On the completion of laparoscopy and before the general anaesthetic is reversed ]
    The precise location in the horizontal and vertical planes of the right and left lateral port sites will be measured to assess port symmetry.


Secondary Outcome Measures :
  1. Neuropathy [ Time Frame: Before, immediately after and 2 weeks after gynaecological surgery ]
    Evidence of ilio-hypogastric and ilio-inguinal neuropathy will be sought at the above time frames.



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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Due to undergo elective gynaecological surgery, including laparoscopy

Exclusion Criteria:

  • Previous laparoscopy
  • Junior intern as primary surgeon

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093430


Contacts
Contact: Adam Magos, MD FRCOG 020 7794 0500 ext 33863 a.magos@medsch.ucl.ac.uk

Locations
United Kingdom
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
Contact: Adam Magos, MD FRCOG    +44 20 7794 0500 ext 33863    a.magos@medsch.ucl.ac.uk   
Principal Investigator: Adam Magos, MD FRCOG         
Sponsors and Collaborators
Royal Free Hampstead NHS Trust
Investigators
Principal Investigator: Adam Magos, MD FRCOG Royal Free Hamsptead NHS Trust

Responsible Party: Dr. Adam Magos,. Consultant Gynaecologist/Honorary Senior Lecturer, Royal Free Hospital, Hampstead, London NW3 2QG, UK
ClinicalTrials.gov Identifier: NCT01093430     History of Changes
Other Study ID Numbers: AM2009/1
First Posted: March 25, 2010    Key Record Dates
Last Update Posted: March 25, 2010
Last Verified: March 2010

Keywords provided by Royal Free Hampstead NHS Trust:
Gynecological surgery
laparoscopic ports
neuropathy