Trial document




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  DRKS00014720

Trial Description

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Title

Adhesion prevention in endometriosis surgery using 4DryField® PH

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to demonstrate the reduction of postoperative adhesions by using the medical device 4DryField® PH. Adhesions are bands of scar tissue that form predominantly as a result of surgery. They cause internal organs to stick together or to the abdominal wall and occur in up to 93% of patients after surgery in the abdominal and pelvic region. Their prevention is an important issue, particularly due to the possible severe consequences, including chronic pain, secondary female infertility and intestinal obstruction.
4DryField® PH is a purely plant-based medical device, approved for adhesion prevention, which showed excellent tolerability and efficacy in adhesion prevention in various independent studies. It does not contain any components of animal or human origin and is:

- biocompatible, i.e. has no negative impact on the treated tissue or its metabolism
- pyrogen-free, i.e. it does not contain any ingredients that might induce fever
- hypoallergenic, i.e. has a very low allergenic potential.

The main objective of this study is to find out if the use of 4DryField® PH leads to a reduction of adhesions after endometriosis surgery. In addition, it will be determined if this treatment can also be used to reduce possible surgical consequences such as pain, infections, abscesses or wound healing disturbances and increase the rate of pregnancies.

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Brief Summary in Scientific Language

The purpose of this study is to demonstrate the reduction of postoperative adhesions by using the CE certified medical device 4DryField® PH. Adhesions were detected in more than 90% of patients after extensive abdominal operations and in 55-100% of patients after pelvic operations. In about 10-20% of patients adhesions lead to severe health impairments, including chronic pain, intestinal obstruction and secondary female infertility. Adhesions are even the most common cause of secondary female infertility. Furthermore, adhesions lead to a high incidence of re-admissions and re-operations. Due to the high incidence of postoperative adhesions a surgical intervention should be performed as atraumatically as possible. Nevertheless, even the most thorough, microsurgical surgical technique is not able to prevent the formation of adhesions. Therefore, a routine prophylaxis against postoperative adhesions is meaningful and recommended, particularly in abdominal and pelvic interventions.
4DryField® PH is a medical device made from purified, modified starch, approved for adhesion prevention, which showed excellent tolerability and efficacy in adhesion prevention in various independent studies. It does not contain any components of animal or human origin and is sterile, pyrogen-free, biocompatible and hypoallergenic.
The main objective of this study is to find out if the use of 4DryField® PH leads to a reduction of adhesions after endometriosis surgery. In addition, it will be determined if this treatment can also be used to reduce possible surgical consequences such as pain, infections, abscesses or wound healing disturbances and increase the rate of pregnancies.

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Organizational Data

  •   DRKS00014720
  •   2018/05/09
  •   [---]*
  •   no
  •   Approved
  •   217/2018BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  •   U1111-1213-4142 
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Health Condition or Problem studied

  •   N80 -  Endometriosis
  •   K66.0 -  Peritoneal adhesions
  •   N73.6 -  Female pelvic peritoneal adhesions
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Interventions/Observational Groups

  •   Adhesion prevention during surgery is carried out using 4DryField® PH
  •   No adhesion prevention with an additional special barrier is carried out, but the standard flushing with saline solution is conducted
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Other
  •   Prevention
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

At the time of the second laparascopy the adhesion score (which considers incidence, extent, and severity of adhesions) of patients treated with 4DryField® PH is lower than that of the patients treated with saline solution.
The primary endpoint is a direct measure of the test product’s ability to prevent adhesions.
Firstly, predilection sites of adhesions (and their extent) are determined using a scoring system based on the scores of the American Fertiliy Society (AFS scores). In the second operation the resulting adhesions are evaluated individually for each area with regard to their severity and extent, also modified from the AFS scores. Finally, quotients are calculated from the extent of the adhesion and the degree of the corresponding predilection site (the maximum value is one as adhesions only form at predilection sites). The quotients are then multiplied by factor 4 to achieve scores in the order of the AFS scores. After product formation with the respective severity score, the obtained products of all organs are added up. The sum is then divided by the number of predilection sites, resulting in the total score. Accordingly, this score has a minimum value of 0 and a maximum value of 16. The entire calculation can be described with the equation under 'Further study documents'.

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Secondary Outcome

1. Patients treated with 4DryField® PH have a lower postoperative pain score than patients treated with sodium chloride solution.
2. In patients treated with 4DryField® PH, postoperative wound healing disturbances are less common.
3. In patients treated with 4DryField® PH, infections are less common postpoperatively.
4. In patients treated with 4DryField® PH, abscesses are less common postoperatively.
5. In patients treated with 4DryField® PH, reduced adhesion formation lowers the need for reoperations for adhesiolysis.
6. Patients treated with 4DryField® PH less frequently have to undergo surgery-related reoperations (not including adhesiolysis).
7. In women with wish to conceive and treated with 4DryField® PH, the reduced postoperative adhesion formation leads to an increased frequency of pregnancies.

The secondary endpoints regarding frequency of adhesiolysis surgeries and pregnancies are indirect measures for the test product’s capability to prevent adhesions. The secondary endpoint “postoperative pain” also is an indirect measure as adhesion formation is a possible cause of postoperative pain. However, this endpoint does not necessarily correlate directly and can only be determined less robustly. The secondary endpoints regarding incidence of postoperative infections, abscesses, reoperations (other than adhesiolysis), and wound healing disturbances include an expanded issue of the added benefit of the test product and are indirect measures of its supportive effect on wound healing.
For the secondary hypotheses data are collected during hospitalization and follow-up. During the hospitalization, abscesses, wound healing disturbances, infections and necessary reoperations are documented. After the second operation patients are interviewed daily regarding cycle-independent pelvic pain (based on a pain score). As part of the follow-up, patients are interviewed by telephone after 1, 6 and 12 months. It is determined if reoperation for adhesiolysis was recommended by a postdischarge doctor, how the pain develops (divided into cycle-independent pelvic pain, pain during menstruation (dysmenorrhea), pain during intercourse (dyspareunia), pain during defecation (dyschezia) and pain during urination (dysuria)), and (at the last interview date), if a pregnancy has occurred in women with (maintained) wish to conceive.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/07/25
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Deep infiltrating endometriosis (DIE) or extensive peritoneal and/ or ovarian endometriosis with indication for second laparoscopy.
Consent of treatment with conventional surgical procedure after separate information and written consent to participate in the study.

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Exclusion Criteria

Pregnant patients, breastfeeding patients, patients with known incompatibility of starch-containing substances, patients that do not undergo resection of endometrial tissue during the first laparoscopy and, therefore, do not require any adhesion prevention treatment.

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Addresses

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    • PlantTec Medical GmbH
    • Bleckeder Landstrasse 22
    • 21337  Lueneburg
    • Germany
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    • Stv. Ärztlicher Direktor Gynäkologie, Department für Frauengesundheit
    • Mr.  Prof. Dr.  Bernhard  Krämer 
    • Calwerstrasse 7
    • 72076  Tuebingen
    • Germany
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    • Stv. Ärztlicher Direktor Gynäkologie, Department für Frauengesundheit
    • Mr.  Prof. Dr.  Bernhard  Krämer 
    • Calwerstrasse 7
    • 72076  Tuebingen
    • Germany
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Sources of Monetary or Material Support

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    • PlantTec Medical GmbH
    • Bleckeder Landstrasse 22
    • 21337  Lueneburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Formel
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* This entry means the parameter is not applicable or has not been set.