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

• Sponsor: Royal Free Hampstead NHS Trust (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01093430
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Sep 1, 2009
• Anticipated Primary Completion Date: Sep 1, 2011
• Anticipated Study Completion Date: Sep 1, 2011

Arms and Interventions

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 Names: 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 Names: Visual

Outcome Measures

Primary Outcome Measures

1. Symmetry of lateral laparoscopic ports [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Due to undergo elective gynaecological surgery, including laparoscopy

Exclusion Criteria:

• Previous laparoscopy

• Junior intern as primary surgeon

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Free Hospital	London		United Kingdom	NW3 2QG

Sponsors and Collaborators

• Royal Free Hampstead NHS Trust

Investigators

• Principal Investigator: Adam Magos, MD FRCOG, Royal Free Hamsptead NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01093430
• Other Study ID Numbers: AM2009/1
• First Posted: Mar 25, 2010
• Last Update Posted: Mar 25, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: Gynecological surgery; laparoscopic ports; neuropathy

Study Results

No Results Posted as of Mar 25, 2010