Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological Surgery (ADBEE)
|ClinicalTrials.gov Identifier: NCT01745432|
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : July 6, 2016
Adhesions are the most frequent complication of abdominopelvic surgery. They are internal scar tissues which form as a result of surgery which may abnormally join together what were once separate tissues and organs.
This study will assess the safety and usability of anti-adhesion agent (gel) when used after laparoscopic surgery.
The study will enroll 30 patients, (randomised 2:1) with safety primary endpoint (adverse events in ADBLOCK and surgery only group) assessed at 28 days
|Condition or disease||Intervention/treatment||Phase|
|UTERINE MYOMAS||Device: ADBLOCK||Phase 1|
Title: Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological surgery
Design: Randomised controlled study to assess the safety, manageability and usability of ADBLOCK when used as an adjunct to laparoscopic surgery for the primary removal of ('virgin') myomas in women wishing to improve pregnancy outcomes.
Use of ADBLOCK will be assessed against laparoscopic surgery alone in 30 patients (randomised 2:1 ADBLOCK/surgery) with a pneumoperitoneum ≤90minutes.
Clinical Site Locations:
- Oldenburg, Germany
- Neuss, Germany
- Berlin, Germany
Patient Population: Women who have not completed their family planning and who are undergoing primary ('virgin') laparoscopic myomectomy with an aim to improve pregnancy outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological Surgery|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||September 2015|
Experimental: ADBLOCK +laparoscopic surgery
Adhesion Barrier System is site-specific sprayable adhesion barrier gel administered on the surgical field to reduce risk of adhesion formation.
Other Name: Adhesion Barrier System
No Intervention: laparoscopic surgery
Laparoscopic surgery only without use of adhesion barrier
- Safety as evaluated by assessment of adverse events in ADBLOCK and surgery only group [ Time Frame: up to 28 days ]The rate of adverse events will be compared in treatment arm and control arm
- Postoperative recovery [ Time Frame: up to 28 days ]
- Safety as evaluated by assessment of adverse events in ADBLOCK and surgery only group [ Time Frame: up to 24 months ]
- Pain [ Time Frame: before discharge, 7d, 14d, 1mo, 3mo, 6mo, 12mo, 24mo ]
- Unanticipated device-related adverse events [ Time Frame: before discharge, 7d, 14d, 1mo, 3mo, 6mo, 12mo, 24mo ]
- Pregnancy (in women seeking to become pregnant) [ Time Frame: 3mo, 6mo, 12mo, 24mo ]
- Menstrual Cycle [ Time Frame: 1m, 3mo, 6mo, 12mo, 24mo ]
- Miscarriage [ Time Frame: 1mo, 3mo, 6mo, 12mo, 24mo ]
- Procedure related hospital readmission [ Time Frame: 7d,14d, 1mo, 3mo, 6mo, 12mo, 24mo ]
- Impact of covariates / Including length of pneumoperitoneum [ Time Frame: before discharge, 7d,14d, 1mo, 3mo, 6mo, 12mo, 24mo ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745432
|Klinik für Minimal Invasive Chirurgie|
|Berlin, Germany, 14129|
|Johanna Etienne Krankenhaus Neuss|
|Neuss, Germany, 41462|
|Pius Krankenhaus Oldenburg|
|Oldenburg, Germany, 26121|
|Principal Investigator:||Rudy-Leon De Wilde, MD PhD||Pius Krankenhaus Oldenburg|