We conducted a prospective randomized single blind – subject study in the University Clinic of Gynecology of Pius-Hospital Oldenburg. The primary objective of the ADBEE study was to assess the safety and manageability of ADBLOCK when used as an adjunct to laparoscopic surgery for the primary of myomas in women wishing to improve pregnancy outcomes.
The study population included 32 women aged between 18–45 years, in good general health condition, who have not completed their family planning and who are undergoing primary (‘virgin’) laparoscopic myomectomy with an aim to improve pregnancy outcomes. The patients were randomized in 2 groups, ADBLOCK arm with 21 patients and surgery only arm with 11 patients. The study was single blind – subject and the investigators were blinded to treatment group assignment until completion of uterine suturing and prior to removal of the endoscope. A vigorous follow-up of subjects was organized, focusing on its two critical characteristics: completeness and duration. Completeness represented the percentage of subjects who returned to every planed follow – up appointments. The patients were evaluated in a specific period of time, which defined the duration of follow-up. Safety of the ADBLOCK was estimated after analyzing and documentation of any adverse events occurred, clinical and physical examination of patients as well as evaluation of laboratory measures.
There were 25 adverse events reported in ADBLOCK treatment group and 12 events in NO-ADBLOCK group over the 24-months treatment. All adverse events in both treatment arms were not anticipated, with all events in the ADBLOCK group being resolved.
At 28 days, there was no significant difference in proportion of events between the two treatments (p = 0.440). Overall, the number of events reported was low and the severity of events was generally mild with an unlikely or no relationship to treatment.
There were no unanticipated device related adverse events seen in both treatment groups over the immediate post-operative period or during the 24 months follow up period.
By 12 weeks all patients reported their wound as healing well or healed and at 6 months all wounds were reported as healed. There were no differences between both treatment groups regarding the use of painkillers over 24 months follow up period.
This clinical first – in – human study, sustained by a rigorous follow-up of the subjects has demonstrated that ADBLOCK is a safe product, presenting no additional safety risk or burden to the patients over surgery alone. The device was relatively easy to use, with a low device failure rate that had no impact on the surgical procedures.
Highlights
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We conducted a prospective, randomized, single-blind ADBEE study, sustained by a rigorous follow up care of the subjects.
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The long follow up was focused on its two critical characteristics: completeness and duration.
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In terms of safety, the follow up allowed to monitor the postoperative recovery as well as to diagnose and manage any possible adverse events.
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First – in – human clinical study for ADBEE provided evidence of safety and good manageability of ADBLOCK.
Introduction
Adhesions are the most frequent complication of abdominopelvic surgery . They are an almost inevitable consequence of abdominopelvic surgery, the healthcare burden being considerable . Despite advances in surgery including laparoscopy, the burden has not changed and the risk of admission to hospital for adhesion – related complications following gynaecological procedures is similar whether they are undertaken by laparotomy or laparoscopy .
The postoperative adhesions have a substantial impact on healthcare resources due to many related complications such as intestinal obstruction, infertility, chronic pelvic pain and also due to considerable increase of economic costs .
The amplitude and the gravity of adhesions have been underestimated by most of the surgeons since the occurrence of adhesions is unpredictable . Recurrent complications are often treated by physicians or specialists other than the initial surgeon and many years after the initial operation. Even if the adhesions can be present they may be asymptomatic, in which case they remain undiagnosed in most of the cases . Moreover, the efforts to prevent adhesions remain unsuccessful, because of the biochemical complexities and still incompletely understood aetiology of the adhesions formation and due to the lack of good predictive animal models . Also, there has been a long track record of failure or limited use of traditional prevention strategies, until the recent introduction of newer agents . The two major strategies for the prevention of adhesions are a meticulous surgical technique and applying adjuvants . A careful surgical technique that all surgeons should apply includes a gentle tissue handling, minimizing the surgical trauma, rigorous haemostasis, cautious cauterization to prevent ischaemia, irrigation to minimize serosal drying, avoiding intraperitoneal infection and also avoiding the introduction of foreign material such as glove powder . While optimal surgical technique following the principles of microsurgery in open and laparoscopic procedures is a fundamental step in reducing adhesions , surgery alone is not enough to prevent adhesions formation . The use of safe and effective anti-adhesion agents as part of the strategy to reduce the formation of adhesions has become mandatory . Following the efforts of different authoritative organizations and groups of expert surgeons, there is a strong recommendation for research of new, safe and effective anti-adhesion agents which can be used in laparoscopic and open surgery to reduce de novo adhesions formation, as well as those that reform following adhesiolysis .
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