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Differences in Peritoneal Stem Cells in Women With and Without Adhesions After Gynaecological Surgery

Primary Purpose

Peritoneal Adhesions

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
Tissue sample donation
Sponsored by
Pius-Hospital Oldenburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Peritoneal Adhesions focused on measuring Peritoneal adhesions, Stem cells, MSC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Woman equal to and above 18 years of age.
  2. Woman with a negative pregnancy test at the time of recruitment, and sufficient contraception from time of
  3. Woman with any gynecological pathology requiring scheduled pelvic gynecological surgery, either laparotomy or laparoscopy.
  4. Woman without primary peritoneal disease.

Exclusion Criteria:

  1. Woman with a primary peritoneal pathology.
  2. Emergency surgery
  3. Patients under systemic immunosuppressive therapy in the previous 6 months
  4. Patients with current intra-abdominal or pelvic abscess or systemic infection
  5. Pregnant woman
  6. Simultaneous participation in another clinical trail

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Arm Label

    No previous surgery, adhesions present.

    No previous surgery, no adhesions present.

    Previous surgery, adhesions present.

    Previous surgery, no adhesions present.

    Arm Description

    Patients have had no previous abdominal surgery. Inspection shows peritoneal adhesions.

    Patients have had no previous abdominal surgery. Inspection shows no peritoneal adhesions.

    Patients have had previous abdominal surgery. Inspection shows peritoneal adhesions.

    Patients have had previous abdominal surgery. Inspection shows no peritoneal adhesions.

    Outcomes

    Primary Outcome Measures

    Pluripotency markers (Sox2, Nanog, Klf 4, Oct 3/4)
    days since previous surgery

    Secondary Outcome Measures

    Full Information

    First Posted
    July 25, 2016
    Last Updated
    July 25, 2016
    Sponsor
    Pius-Hospital Oldenburg
    Collaborators
    University of Leipzig, University of Oldenburg
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02847676
    Brief Title
    Differences in Peritoneal Stem Cells in Women With and Without Adhesions After Gynaecological Surgery
    Official Title
    Differences in Peritoneal Stem Cells in Women With and Without Adhesions After Gynaecological Surgery
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    January 2017 (Anticipated)
    Study Completion Date
    August 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pius-Hospital Oldenburg
    Collaborators
    University of Leipzig, University of Oldenburg

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Our study aims to characterise a possible pluripotent cell population in the abdomen responsible for peritoneal adhesions. We therefore want to take samples from women undergoing planned laparoscopic surgery with and without adhesions, isolate the cells and characterise them for markers of pluripotency.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peritoneal Adhesions
    Keywords
    Peritoneal adhesions, Stem cells, MSC

    7. Study Design

    Enrollment
    40 (Anticipated)
    Biospecimen Retention
    Samples With DNA
    Biospecimen Description
    Peritoneal tissue samples taken from Adhesions, Peritoneal lining and omentum.
    Target Follow-Up Duration
    1 Day

    8. Arms, Groups, and Interventions

    Arm Title
    No previous surgery, adhesions present.
    Arm Description
    Patients have had no previous abdominal surgery. Inspection shows peritoneal adhesions.
    Arm Title
    No previous surgery, no adhesions present.
    Arm Description
    Patients have had no previous abdominal surgery. Inspection shows no peritoneal adhesions.
    Arm Title
    Previous surgery, adhesions present.
    Arm Description
    Patients have had previous abdominal surgery. Inspection shows peritoneal adhesions.
    Arm Title
    Previous surgery, no adhesions present.
    Arm Description
    Patients have had previous abdominal surgery. Inspection shows no peritoneal adhesions.
    Intervention Type
    Procedure
    Intervention Name(s)
    Tissue sample donation
    Intervention Description
    Patients undergo planned gynaecological surgery. Tissue samples, which are routinely taken, are donated.
    Primary Outcome Measure Information:
    Title
    Pluripotency markers (Sox2, Nanog, Klf 4, Oct 3/4)
    Description
    days since previous surgery
    Time Frame
    at least 10

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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 Population Description
    All patients undergoing scheduled pelvic gynecological surgical treatment, at the Gynecology Department of Pius Hospital, Oldenburg.
    Sampling Method
    Non-Probability Sample
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rudy Leon De Wilde, Prof. dr. dr. med
    Phone
    0441 2291501
    Email
    gyn-sekretariat@pius-hospital.de

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Differences in Peritoneal Stem Cells in Women With and Without Adhesions After Gynaecological Surgery

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