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

Laparoscopy Clinical Trial

Official title:

Anterior Superior Iliac Spine - A Useful Surface Anatomical Landmark for Safe and Symmetric Accessory Laparoscopic Port Entry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01093430
• Other study ID #: AM2009/1
• Status: Recruiting
• Phase: N/A
• First received: March 23, 2010
• Last updated: March 24, 2010
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: March 2010
• Source: Royal Free Hampstead NHS Trust
• Contact: Adam Magos, MD FRCOG
• Phone: 020 7794 0500
• Email: a.magos[@]medsch.ucl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Due to undergo elective gynaecological surgery, including laparoscopy

Exclusion Criteria:

• Previous laparoscopy

• Junior intern as primary surgeon

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparoscopy
• Surgical Techniques

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Royal Free Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Free Hampstead NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symmetry of lateral laparoscopic ports	The precise location in the horizontal and vertical planes of the right and left lateral port sites will be measured to assess port symmetry.	On the completion of laparoscopy and before the general anaesthetic is reversed	No
Secondary	Neuropathy	Evidence of ilio-hypogastric and ilio-inguinal neuropathy will be sought at the above time frames.	Before, immediately after and 2 weeks after gynaecological surgery	No