Differences in Peritoneal Stem Cells in Women With and Without Adhesions After Gynaecological Surgery
1 other identifier
observational
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2016
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2016
CompletedFirst Posted
Study publicly available on registry
July 28, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedJuly 28, 2016
July 1, 2016
5 months
July 25, 2016
July 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pluripotency markers (Sox2, Nanog, Klf 4, Oct 3/4)
days since previous surgery
at least 10
Study Arms (4)
No previous surgery, adhesions present.
Patients have had no previous abdominal surgery. Inspection shows peritoneal adhesions.
No previous surgery, no adhesions present.
Patients have had no previous abdominal surgery. Inspection shows no peritoneal adhesions.
Previous surgery, adhesions present.
Patients have had previous abdominal surgery. Inspection shows peritoneal adhesions.
Previous surgery, no adhesions present.
Patients have had previous abdominal surgery. Inspection shows no peritoneal adhesions.
Interventions
Patients undergo planned gynaecological surgery. Tissue samples, which are routinely taken, are donated.
Eligibility Criteria
All patients undergoing scheduled pelvic gynecological surgical treatment, at the Gynecology Department of Pius Hospital, Oldenburg.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pius-Hospital Oldenburglead
- University of Leipzigcollaborator
- University of Oldenburgcollaborator
Biospecimen
Peritoneal tissue samples taken from Adhesions, Peritoneal lining and omentum.
Central Study Contacts
Study Design
- Study Type
- observational
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Dr. med
Study Record Dates
First Submitted
July 25, 2016
First Posted
July 28, 2016
Study Start
August 1, 2016
Primary Completion
January 1, 2017
Study Completion
August 1, 2017
Last Updated
July 28, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share