Evaluating Clinical Effects of a Spray-Type Bio-absorbable Adhesion Barrier System in Paediatric Patients

Study Overview
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Brief Summary
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This is a prospective randomized single-blind study where a placebo group served the control, to confirm the efficacy and safety of AdSpray™ as an inhibitory effect of postoperative adhesion formation in paediatric patients who underwent laparotomy with stoma.

Detailed Description
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Postoperative adhesions are fibrovascular bands connecting the parietal peritoneum to the visceral peritoneum of intra-abdominal organs, or connecting intra-abdominal organs to one another, which developed unavoidably following virtually all body cavity surgeries. Adhesions affect up to 80-93% of patients following abdominal surgery. Being the leading cause of postoperative small bowel obstruction, it could potentially cause other enormous clinical problems including difficulty in subsequent operations, infertility, and chronic pain. The incidence of adhesion-related morbidity is estimated to be 2.2% to 19.5% in the pediatric population, among which large proportion of patients required subsequent surgical intervention. A variety of techniques and products (e.g. bioresorbable physical barrier agents, pharmacological adjuncts, etc) have been advocated for preventing postoperative adhesion formation. However, to date, no single treatment is proven to be effective and adhesions still remain a significant, unresolved postoperative complication both in adults and paediatric populations. To reduce postoperative adhesions, Terumo Corporation (Tokyo, Japan) has developed an adhesion barrier system (AdSpray™; Terumo Corporation, Tokyo, Japan) which is easy to use at the treatment site in various surgical procedures. Its ability of adhesion prevention had been demonstrated in porcine model study. Cezar et al and Suto et al subsequently published two human prospective randomized controlled trials on the use of this barrier system in adult patients undergoing gynaecological and gastrointestinal operations, which confirmed its safety and efficacy. However, to date, studies on the use of anti-adhesion agents in children are scarce and there is no study on this novel barrier system (AdSpray™) in children. In view of this, we plan to conduct a prospective randomized single-blind study where a placebo group served the control, to confirm the efficacy and safety of AdSpray™ as an inhibitory effect of postoperative adhesion formation in paediatric patients who underwent laparotomy with stoma. B. Study objective To investigate the effect of a novel spray-type, novel dextrin hydrogel adhesion barrier (AdSpray™; Terumo Corporation, Tokyo, Japan) on postsurgical adhesions. C. Study design and methods This is a prospective, single center, single-blinded randomized controlled trial using a parallel arm design and placebo group as the control. Patient enrollment will start in March 2022 and expected to end in 2023.

Official Title
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A Prospective Single-blind Randomised Controlled Trial Evaluating Clinical Effects of a Novel Spray-Type Bio-absorbable Adhesion Barrier System (AdSpray™) in Paediatric Patients Requiring Laparotomy

Conditions
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Surgical Adhesions

Intervention / Treatment
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* Device: Adspray
* Procedure: Placebo-control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring laparotomy and staged operation with closure of stoma as second operation e.g. Necrotising Enterocolitis, Anorectal malformation, Hirschsprung's disease, etc. Exclusion Criteria: A history of hypersensitivity to substances derived from corn starch A history of surgery in the abdominal cavity or pelvic cavity accompanied by a laparotomy scar Patients with peritonitis Laparoscopic assessment of adhesions may not be performed safely at the second-look surgery.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible subjects will be identified, and parents will be approached for patient recruitment. Once consent to participation is signed, the patients will be randomised into either treatment group (AdSpray™) or placebo-controlled group in 1:1 ratio using simple randomization. The adhesion-assessment team will be blinded to the group allocated. The spray will be prepared according to the group allocated by a dedicated scrub nurse. For treatment group, AdSpray™ will be instilled into the drug chamber; for placebo group, saline will be instilled instead.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Application of AdSpray™ over all organs under the laparotomy incision at the end of operation | Device: Adspray<br>* Application of AdSpray™ over all organs under the laparotomy incision at the end of operation<br>|
| Placebo Comparator: Control Arm<br>Spray with saline would be applied to organs under incision | Procedure: Placebo-control<br>* Spray with saline would be applied to organs under incision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adhesion | The number of participants developed adhesion during the study period at the second operation assessment | 6 months | 
| Extent of adhesion | Extent of adhesion is classified into 4 grade: Grade 0 - none, Grade 1 - adhesion less than 1/3 the length of incision, Grade 2 - adhesions between 1/3 and <2/3 the length of the incision, Grade 3 - Adhesion great or equal than 2/3 the length of the incision | 6 months | 
| Severity of adhesion | Severity of adhesion is classified into 4 grade: Grade 0 - none, Grade 1 - film-like with no neovascularisation, Grade 2 - moderately thick with partial neovascularisation, Grade 3 - thick, solid adhesion with neovascularisation | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Intestinal obstruction, abscess, peritonitis, surgical wound infection, malfunction of device, etc. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paediatric surgery, surgical adhesions, medical device, biodegradable anti-adhesive agent