- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02847676
Differences in Peritoneal Stem Cells in Women With and Without Adhesions After Gynaecological Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Peritoneal adhesions are connective tissue bands between two normally separate anatomical structures within the abdominal or pelvic cavity. Those adhesions can occur after gynaecological or other surgeries involving the pelvis or abdomen. Adhesions have severe clinical as well as economical Consequences. There is substantial morbidity (from chronical pain to obstructions and infertility) and a higher surgical risk if additional surgery is needed, due to a higher intraoperative blood loss and a higher incidence of lacerations when peritoneal adhesions are present. In combination with a prolonged surgery duration, the economical impact is tremendous. A 2011 study estimated the cost of adhesion - related surgeries to be 2,3 billion US dollar exclusively in the USA. 46.3% of those surgeries had their origin or localisation in the gynaecological area. The genesis of adhesiolysis - obligatory peritoneal adhesions remains unclear to this date.
After all surgeries cytokine induced fibrotic bands appear within 72 hours. Usually those bands are eliminated by a fibrinolytic sequence within 10 days.
For Adhesions that persist afterwards the generally accepted assumption is, that there is a failure of the fibrinolytic sequence with unknown origin. Adhesions which persist for more than 10-14 days become thicker and vascularised. In those "adult" adhesions not only fibrin is found but also fat tissue, smooth muscles and myelinised and un - myelinised axons.
In developmental biology those tissues differentiate from different germ layers, namely mesoderm and ectoderm. Finding cells from multiple germ layers points towards a pluri -, multi-, or stem cell like precursor cell from which those adhesions develop. Such a cellpopulation has not been characterised in the abdomen to the date of writing, though Studies have shown evidence (ranging from mesothelial - to - mesenchymal shift to Clusters of differentiation from multiple germ layers) which made multiple researchers postulate a pluripotent precursor cell located in the submesothelium.
In our research we will therefore take peritoneal samples from adhesions, peritoneal wall lining and omentum in subjects with and without peritoneal adhesions in subjects undergoing indicated laparoscopic surgery at the gynaecological ward at the Pius hospital in Oldenburg.
The samples are routinely taken as part of the procedure and usually discarded. At least 24 hours prior to surgery, the subjects will have a chance to give their informed consent to donate those samples for our study. The study is thus designed in a way that subjects won't undergo additional risk by participating in the study. Taking part or the refusal hereof won't have any effect on the treatment or surgical outcome for the subjects. Also, taking part in our study won't have any benefits or additional risks for the subjects.
The samples will then be taken to the university of Leipzig, where we will culture, isolate and characterise the cells. Characterisation will mostly be the application of pluripotency markers, cell sorting and immunoassays. Expression profiles will be used to further understand the mesothelial - to - mesenchymal shift. Depending on our findings the protocol for analysis will be adjusted in consultation with Prof. dr. dr. De Wilde and Prof. dr. Bader.
The study will approximately take 6 months, with an additional 6 months for writing and publication. The study is funded by the research funding pool of the university of Oldenburg.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Rudy Leon De Wilde, Prof. dr. dr. med
- Phone Number: 0441 2291501
- Email: gyn-sekretariat@pius-hospital.de
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Woman equal to and above 18 years of age.
- Woman with a negative pregnancy test at the time of recruitment, and sufficient contraception from time of
- Woman with any gynecological pathology requiring scheduled pelvic gynecological surgery, either laparotomy or laparoscopy.
- Woman without primary peritoneal disease.
Exclusion Criteria:
- Woman with a primary peritoneal pathology.
- Emergency surgery
- Patients under systemic immunosuppressive therapy in the previous 6 months
- Patients with current intra-abdominal or pelvic abscess or systemic infection
- Pregnant woman
- Simultaneous participation in another clinical trail
Study Plan
How is the study designed?
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
No previous surgery, adhesions present.
Patients have had no previous abdominal surgery.
Inspection shows peritoneal adhesions.
|
Patients undergo planned gynaecological surgery.
Tissue samples, which are routinely taken, are donated.
|
No previous surgery, no adhesions present.
Patients have had no previous abdominal surgery.
Inspection shows no peritoneal adhesions.
|
Patients undergo planned gynaecological surgery.
Tissue samples, which are routinely taken, are donated.
|
Previous surgery, adhesions present.
Patients have had previous abdominal surgery.
Inspection shows peritoneal adhesions.
|
Patients undergo planned gynaecological surgery.
Tissue samples, which are routinely taken, are donated.
|
Previous surgery, no adhesions present.
Patients have had previous abdominal surgery.
Inspection shows no peritoneal adhesions.
|
Patients undergo planned gynaecological surgery.
Tissue samples, which are routinely taken, are donated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pluripotency markers (Sox2, Nanog, Klf 4, Oct 3/4)
Time Frame: at least 10
|
days since previous surgery
|
at least 10
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
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
- PHDW-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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