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Clinical Trials/DRKS00009511
DRKS00009511
Completed
Phase 4

Randomised, controlled clinical study with patients with endometriosis and the desire to have children – Comparison between peritoneal ablation by excision only and excision with the application of an adhesionbarrier

Pius-Hospital Universitätsklinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie0 sites58 target enrollmentOctober 13, 2015
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ConditionsN80.9N73.6Endometriosis, unspecifiedFemale pelvic peritoneal adhesions

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
N80.9
Sponsor
Pius-Hospital Universitätsklinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie
Enrollment
58
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

58 female patients were included in the analysis. The patients were 29.94 ± 5.05 years old and had a BMI of 26.0 ± 5.36 kg/m². 20% of the patients had at least one relative with endometriosis. 51% of patients had previously undergone surgery for endometriosis. 43% of patients had stage I endometriosis, 24% had stage II endometriosis, and the remaining patients were distributed among stages 0, IV, and V (mean 15.0 ± 27.25 points in the rASRM classification). Pre-existing adhesions were detected in 49% of patients (mean 10.06 ± 23.01 points in the rASRM adhesion score). No adverse events occurred. Further analysis on pain and pregnancy will be performed in the coming months.

Registry
who.int
Start Date
October 13, 2015
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Pius-Hospital Universitätsklinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie

Eligibility Criteria

Inclusion Criteria

  • •Preoperative inclusion criteria:
  • •\- Women aged \> 18 years with endometriosis\-associated symptoms such as dysmenorrhea, dyspareunia, pelvic pain, back pain, Rectal, Defecation pain (the presence of individual complaints are accepted as an inclusion criterion)
  • •\- Subjects are in a good general state of health
  • •\- Up to endometriosis can be no other obvious diseases associated with chronic pain or other cause of abdominal pain
  • •\- The subjects have reproductive desire
  • •\- Subjects understand the course of the study and agree to participate
  • •\- The subjects must be the capacity to consent, that is, they must understand the risks and benefits of the study and are free to agreement to participate in the study
  • •\- There is a written consent form, by hand filled and signed, which has been confirmed by the competent ethics committee before.
  • •Intraoperative inclusion criteria:
  • •\- Pelvic Endometriosis

Exclusion Criteria

  • •Preoperative exclusion criteria:
  • •\- Existing pregnancy, including an ectopic pregnancy
  • •\- In clinical examination there are findings of other causes of complaints
  • •\- Chronic diseases different of endometriosis which requires pain management
  • •\- Pre\-treatment with GnRH analogues in a period of 6 months prior to study entry
  • •\- Use of systemic corticosteroids or antineoplastic drugs and / or performing an irradiation
  • •\- Planned additional general surgeries during the same surgery for endometriosis
  • •Intraoperative exclusion criteria:
  • •\- no visible endometriosis foci at laparoscopy
  • •\- Evidence of an existing pregnancy, including a ectopic pregnancy

Outcomes

Primary Outcomes

Not specified

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