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
  Purpose

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


Condition Intervention
Surgical Techniques
Laparoscopy
Procedure: Anterior superior iliac spine
Procedure: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anterior Superior Iliac Spine - A Useful Surface Anatomical Landmark for Safe and Symmetric Accessory Laparoscopic Port Entry

Further study details as provided by Royal Free Hampstead NHS Trust:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 160
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: March 23, 2010
Last Updated: March 24, 2010
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on October 21, 2014