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

March 24, 2010 updated by: Royal Free Hampstead NHS Trust

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital
        • Contact:
        • Principal Investigator:
          • Adam Magos, MD FRCOG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Due to undergo elective gynaecological surgery, including laparoscopy

Exclusion Criteria:

  • Previous laparoscopy
  • Junior intern as primary surgeon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
On the completion of laparoscopy and before the general anaesthetic is reversed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before, immediately after and 2 weeks after gynaecological surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Free Hampstead NHS Trust

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

March 23, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 25, 2010

Study Record Updates

Last Update Posted (Estimate)

March 25, 2010

Last Update Submitted That Met QC Criteria

March 24, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AM2009/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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