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Study to Compare Peritoneal Ablation by Excision Only and Excision With the Use of an Adhesion Barrier

Primary Purpose

Endometriosis

Status

Unknown status

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Excision plus hyaluronic acid gel

Excision only

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, Adhesions, Hyalobarrier®, Hyaluronic acid, Antiadhesion agent, Adhesionbarrier, Pregnancy rate

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women over 18 years with endometriosis-associated pain, like dysmenorrhea, dyspareunia, lower abdominal pain, low-back pain, rectal pain, defecation pain (only one criterion needs to be fulfilled for study inclusion);
Participants are in good general health except for endometriosis related problems;
Except for endometriosis, no existence of an obvious diseases which could cause chronic pain or which could cause abdominal pain;
The participant must have a desire to have children;
Participants must be able to give their consent and must understand the risks associated with a participation in the study;
There must be a signed and dated informed consent which was accepted by the local ethic committee

Exclusion Criteria:

Existent pregnancy including ectopic pregnancy;
Identification of other causes for the discomfort;
Chronic diseases, except endometriosis, which require continuous pain therapy;
Previous application of GnRH analogues 6 month prior to study;
Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation;
Planned additional general surgical procedures during the operation for removal of the endometriotic lesions;
Absence of endometriosis at laparoscopy;
Partial resection of the bowel or urinary bladder for removal of endometriosis

Sites / Locations

Pius-Hospital, Department of Gynecology, Obstetrics and Gynecological Oncology, Carl von Ossietzky UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Excision only

Excision plus hyaluronic acid gel

Arm Description

Laparoscopic excision of endometriotic lesions followed by 3 month of GnRH-Analogue administration

Standard Laparoscopic excision of endometriotic lesions plus application of 10 cc of a hyaluronic acid gel (Hyalobarrier® ), followed by 3 month of GnRH-analogue administration

Outcomes

Primary Outcome Measures

Pregnancy rate

Secondary Outcome Measures

Endometriosis-associated pain

Outcome measure is measured by visual analogue scale

Endometriosis-associated pain

Outcome measure is measured by visual analogue scale

Full Information

NCT ID

NCT02165917

First Posted

April 15, 2014

Last Updated

November 2, 2015

Sponsor

Pius-Hospital Oldenburg

1. Study Identification

Unique Protocol Identification Number

NCT02165917

Brief Title

Study to Compare Peritoneal Ablation by Excision Only and Excision With the Use of an Adhesion Barrier

Official Title

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 Use of an Adhesionbarrier

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

May 2015 (undefined)

Primary Completion Date

May 2017 (Anticipated)

Study Completion Date

May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pius-Hospital Oldenburg

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Endometriosis is a common disease of women in the reproductive age and is an important cause for female infertility. Endometriosis is often associated with the development of adhesions which further compromises the fertility of the affected women. The main purpose of this study is to investigate the pregnancy rate one year after excision of endometriosis and application of GnRH-analogues (Gonadotropin-releasing hormone) for 3 month. Half of the patients will receive traditional endometriosis treatment with the excision of the endometriotic lesions only. The other half will additionally receive a gel which can reduce adhesion formation (Hyalobarrier®). Further study objective is the investigation in the development of different types of endometriosis-associated pain over a period of one year. Potential study participants are women with endometriosis-associated pain and with a desire to have children. It will be investigated in the study if the use of Hyalobarrier® will result in a higher pregnancy rate due to reduced adhesion development.

Detailed Description

Design: Prospective, monocentric, comparative, randomized, semi-blind. There will be 30 subjects in each arm, who will be followed 15 months after surgery. Half of the patients will receive standard laparoscopic excision of the endometriotic lesions only. The other half, after the excision of the endometriosis foci, will receive 10 cc of an antiadhesion agent which contents hyaluronic acid gel (Hyalobarrier®).The subjects will be hospitalized after surgery for at least 2 days. A Vas-Scala will be given to the subjects to estimate the pain before, after surgery and one year after treatment. The participants will record the values each three months after surgery. All subjects will be asked by telephone for the VAS-scala values and for pregnancy (Date of Initiation, clinical evolution) The participation ist voluntary and an Informed consent must be signed before surgery. Subjects are free to withdraw their consent anytime.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometriosis

Keywords

Endometriosis, Adhesions, Hyalobarrier®, Hyaluronic acid, Antiadhesion agent, Adhesionbarrier, Pregnancy rate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Excision only

Arm Type

Placebo Comparator

Arm Description

Laparoscopic excision of endometriotic lesions followed by 3 month of GnRH-Analogue administration

Arm Title

Excision plus hyaluronic acid gel

Arm Type

Active Comparator

Arm Description

Standard Laparoscopic excision of endometriotic lesions plus application of 10 cc of a hyaluronic acid gel (Hyalobarrier® ), followed by 3 month of GnRH-analogue administration

Intervention Type

Procedure

Intervention Name(s)

Excision plus hyaluronic acid gel

Intervention Description

Excision of endometriosis foci by laparoscopic standard methods followed by an application of 10 cc Hyaluronic acid gel, in order to prevent postsurgical adhesions.

Intervention Type

Procedure

Intervention Name(s)

Excision only

Intervention Description

Excision of endometriosis foci by laparoscopic standard methods only.

Primary Outcome Measure Information:

Title

Pregnancy rate

Time Frame

One year after completion of endometriosis treatment (excision followed by 3 month of GnRH-analogues)

Secondary Outcome Measure Information:

Title

Endometriosis-associated pain

Description

Outcome measure is measured by visual analogue scale

Time Frame

The day before laparoscopy is performed

Title

Endometriosis-associated pain

Description

Outcome measure is measured by visual analogue scale

Time Frame

One year after completion of endometriosis treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women over 18 years with endometriosis-associated pain, like dysmenorrhea, dyspareunia, lower abdominal pain, low-back pain, rectal pain, defecation pain (only one criterion needs to be fulfilled for study inclusion); Participants are in good general health except for endometriosis related problems; Except for endometriosis, no existence of an obvious diseases which could cause chronic pain or which could cause abdominal pain; The participant must have a desire to have children; Participants must be able to give their consent and must understand the risks associated with a participation in the study; There must be a signed and dated informed consent which was accepted by the local ethic committee Exclusion Criteria: Existent pregnancy including ectopic pregnancy; Identification of other causes for the discomfort; Chronic diseases, except endometriosis, which require continuous pain therapy; Previous application of GnRH analogues 6 month prior to study; Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation; Planned additional general surgical procedures during the operation for removal of the endometriotic lesions; Absence of endometriosis at laparoscopy; Partial resection of the bowel or urinary bladder for removal of endometriosis

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rudy L De Wilde, Professor

Phone

+49 441 229 1501

gyn-sekretariat@pius-hospital.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rudy L De Wilde, Professor

Organizational Affiliation

Pius-Hospital Oldenburg, Department of Gynecology, Obstetrics and Gynecological Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pius-Hospital, Department of Gynecology, Obstetrics and Gynecological Oncology, Carl von Ossietzky University

City

Oldenburg

State/Province

Lower Saxony

ZIP/Postal Code

26121

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rudy L De Wilde, Professor

Phone

+49 441 229 1501

gyn-sekretariat@pius-hospital.de

First Name & Middle Initial & Last Name & Degree

Rudy L De Wilde, Professor

12. IPD Sharing Statement

Learn more about this trial

Study to Compare Peritoneal Ablation by Excision Only and Excision With the Use of an Adhesion Barrier

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