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

NCT ID: NCT01093430

Last Updated: 2010-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Surgical Techniques Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Anterior superior iliac spine

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Control

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

Intervention Type PROCEDURE

Other Intervention Names

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Bony landmark Visual

Eligibility Criteria

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Inclusion Criteria

* Due to undergo elective gynaecological surgery, including laparoscopy

Exclusion Criteria

* Previous laparoscopy
* Junior intern as primary surgeon
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Royal Free Hampstead NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Royal Free Hospital, Hampstead, London NW3 2QG, UK

Principal Investigators

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Adam Magos, MD FRCOG

Role: PRINCIPAL_INVESTIGATOR

Royal Free Hamsptead NHS Trust

Locations

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Royal Free Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Adam Magos, MD FRCOG

Role: CONTACT

020 7794 0500 ext. 33863

Facility Contacts

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Adam Magos, MD FRCOG

Role: primary

+44 20 7794 0500 ext. 33863

Other Identifiers

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AM2009/1

Identifier Type: -

Identifier Source: org_study_id

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