Is the Anterior Superior Iliac Spine a Useful Landmark at Laparoscopy?
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Royal Free Hampstead NHS Trust.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Royal Free Hampstead NHS Trust
Information provided by:
Royal Free Hampstead NHS Trust
ClinicalTrials.gov Identifier:
NCT01093430
First received: March 23, 2010
Last updated: March 24, 2010
Last verified: March 2010
| Tracking Information | |||||
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| First Received Date ICMJE | March 23, 2010 | ||||
| Last Updated Date | March 24, 2010 | ||||
| Start Date ICMJE | September 2009 | ||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Symmetry of lateral laparoscopic ports [ Time Frame: On the completion of laparoscopy and before the general anaesthetic is reversed ] [ Designated as safety issue: No ] The precise location in the horizontal and vertical planes of the right and left lateral port sites will be measured to assess port symmetry. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01093430 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Neuropathy [ Time Frame: Before, immediately after and 2 weeks after gynaecological surgery ] [ Designated as safety issue: No ] Evidence of ilio-hypogastric and ilio-inguinal neuropathy will be sought at the above time frames. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Is the Anterior Superior Iliac Spine a Useful Landmark at Laparoscopy? | ||||
| Official Title ICMJE | Anterior Superior Iliac Spine - A Useful Surface Anatomical Landmark for Safe and Symmetric Accessory Laparoscopic Port Entry | ||||
| Brief Summary | The purpose of this study is to study port symmetry and the incidence of anterior abdominal wall neuropathy associated with gynaecological surgery. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 160 | ||||
| Estimated Completion Date | September 2011 | ||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 20 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01093430 | ||||
| Other Study ID Numbers ICMJE | AM2009/1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Adam Magos,. Consultant Gynaecologist/Honorary Senior Lecturer, Royal Free Hospital, Hampstead, London NW3 2QG, UK | ||||
| Study Sponsor ICMJE | Royal Free Hampstead NHS Trust | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Royal Free Hampstead NHS Trust | ||||
| Verification Date | March 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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