NCT01093430

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

March 25, 2010

Status Verified

March 1, 2010

Enrollment Period

2 years

First QC Date

March 23, 2010

Last Update Submit

March 24, 2010

Conditions

Surgical TechniquesLaparoscopy

Keywords

Gynecological surgerylaparoscopic portsneuropathy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Neuropathy

    Before, immediately after and 2 weeks after gynaecological surgery

Study Arms (2)

Anterior superior iliac spine

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Procedure: Control

Interventions

Anterior superior iliac spinePROCEDURE

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.

Also known as: Bony landmark
Anterior superior iliac spine
ControlPROCEDURE

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

Also known as: Visual
Control

Eligibility Criteria

Age20 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Due to undergo elective gynaecological surgery, including laparoscopy

You may not qualify if:

  • Previous laparoscopy
  • Junior intern as primary surgeon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Free Hospital

London, NW3 2QG, United Kingdom

RECRUITING

Study Officials

  • Adam Magos, MD FRCOG

    Royal Free Hamsptead NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Magos, MD FRCOG

CONTACT

020 7794 0500a.magos@medsch.ucl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 25, 2010

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

March 25, 2010

Record last verified: 2010-03

Locations

GB(1)