- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07522931
Systematic Anatomical Description of the Female Pelvic Retroperitoneum in Cadavers (RETRO-PELVIS)
Systematic Anatomical Description of the Female Pelvic Retroperitoneum in Cadavers: A Descriptive Study for Gynecologic Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
This is an observational, descriptive cadaveric study designed to characterize the main anatomical relationships of the female pelvic retroperitoneum with direct application to gynecologic surgery.
The study will be conducted using adult female cadavers obtained from an institutional body donation program. Approximately 20 cadavers will be included, depending on availability, providing a total of 40 hemipelves. Each hemipelvis will be considered an independent unit of analysis.
Standardized anatomical dissections of the pelvic retroperitoneum will be performed following a predefined protocol. The main anatomical structures relevant to gynecologic surgery will be identified, including the pelvic ureter, iliac vessels and their branches, obturator nerve, and other predefined anatomical landmarks.
Each hemipelvis will be evaluated using a standardized 10-item anatomical checklist. For every item, the reference anatomical pattern will be classified as present ("Yes"), absent ("No"), or not evaluable ("Not evaluable"). Anatomical variability will be calculated as the proportion of anatomical variants among all evaluable hemipelves for each item.
Standardized photographic documentation will be obtained throughout the dissections. Anatomical variants will be qualitatively described and illustrated whenever possible.
Statistical analysis will be descriptive. Categorical variables will be presented as absolute frequencies and percentages. Anatomical variability will be reported for each checklist item, excluding non-evaluable observations from the denominator.
This study does not involve living human participants, clinical interventions, or identifiable personal data. All procedures will be conducted in accordance with institutional and ethical standards governing the use of donated human bodies for research and education.
The expected outcome is a systematic description of the principal anatomical relationships of the female pelvic retroperitoneum and their anatomical variability, together with the development of a photographic anatomical atlas to support surgical training and gynecologic education.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jorge Garcia Fernandez Principal Investigator, Gynecologist
- Phone Number: +34622595644
- Email: jorgarciafernan@gmail.com
Study Locations
-
-
-
Barcelona, Spain, 08028
- Not yet recruiting
- Universitat de Barcelona - Department of Anatomy and Human Embryology
-
Contact:
- Josep Maria de Anta Vinyals Chief of Department Anatomy and Embriology, Anatomist
- Email: janta@ub.edu
-
-
Barcelona
-
Barcelona, Barcelona, Spain, 08007
- Recruiting
- Universitat de Barcelona - Department of Anatomy and Human Embryology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female cadavers from an institutional body donation program
- Age ≥ 18 years at time of death
- Adequate preservation of pelvic and abdominal retroperitoneal structures
- Anatomical integrity allowing identification of the pelvic ureter, iliac vessels and their main branches, obturator nerve, and other structures included in the anatomical checklist.
- Availability of both hemipelves for comparative analysis
- Authorization for research use according to institutional body donation regulations
Exclusion Criteria:
- Male cadavers
- Prior major pelvic or abdominal surgery significantly altering retroperitoneal anatomy (e.g., hysterectomy, lymphadenectomy, vascular surgery)
- History of pelvic or abdominal radiotherapy
- Advanced pelvic or abdominal malignancy with retroperitoneal involvement
- Severe trauma affecting pelvic or abdominal anatomy
- Poor preservation or significant tissue degradation
- Absence of one or both hemipelves
- Advanced pregnancy at time of death
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cadaveric Specimens
Adult female cadavers obtained from an institutional body donation program.
Specimens will undergo standardized pelvic retroperitoneal dissection, completion of a predefined 10-item anatomical checklist, and photographic documentation.
|
Standardized pelvic retroperitoneal dissection with completion of a 10-item anatomical checklist, observations and photographic documentation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of anatomical variation
Time Frame: Baseline
|
Percentage of anatomical variation for each of the ten predefined anatomical relationships evaluated using a standardized anatomical checklist.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Development of an anatomical atlas
Time Frame: Baseline
|
Standardized photographic documentation of anatomical structures and variants for educational purposes.
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Development of an Applied Anatomical Atlas
Time Frame: through study completion, an average of 1 year
|
Integration of morphometric measurements and standardized photographic documentation to develop a clinically oriented anatomical atlas of the female pelvic and lower abdominal retroperitoneum for educational and surgical applications.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jorge García Fernández, Gynecologist, Hospital Universitari de Bellvitge
Publications and helpful links
General Publications
- Cibula D, Abu-Rustum NR. Pelvic lymphadenectomy in cervical cancer--surgical anatomy and proposal for a new classification system. Gynecol Oncol. 2010 Jan;116(1):33-7. doi: 10.1016/j.ygyno.2009.09.003. Epub 2009 Oct 17.
- Sanna B, Henry BM, Vikse J, Skinningsrud B, Pekala JR, Walocha JA, Cirocchi R, Tomaszewski KA. The prevalence and morphology of the corona mortis (Crown of death): A meta-analysis with implications in abdominal wall and pelvic surgery. Injury. 2018 Feb;49(2):302-308. doi: 10.1016/j.injury.2017.12.007. Epub 2017 Dec 9.
- Sienkiewicz-Zawilinska J, Zawilinski J, Kaythampilla LN, Jankiel M, Urbaniak J, Bereza T, Kowalski W, Loukas M, Walocha J. Autonomic nervous system of the pelvis - general overview. Folia Med Cracov. 2018;58(2):21-44. doi: 10.24425/fmc.2018.124656.
- Ripperda CM, Jackson LA, Phelan JN, Carrick KS, Corton MM. Anatomic relationships of the pelvic autonomic nervous system in female cadavers: clinical applications to pelvic surgery. Am J Obstet Gynecol. 2017 Apr;216(4):388.e1-388.e7. doi: 10.1016/j.ajog.2016.12.002. Epub 2016 Dec 9.
- Kostov S, Slavchev S, Dzhenkov D, Mitev D, Yordanov A. Avascular Spaces of the Female Pelvis-Clinical Applications in Obstetrics and Gynecology. J Clin Med. 2020 May 13;9(5):1460. doi: 10.3390/jcm9051460.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UB-RETROPERITONEO-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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