PEARL: Evaluating Clinical Effects of a Spray-Type Bio-absorbable Adhesion Barrier System in Paediatric Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
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Study objective To investigate the effect of a novel spray-type, novel dextrin hydrogel adhesion barrier (AdSpray™; Terumo Corporation, Tokyo, Japan) on postsurgical adhesions.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Arm Application of AdSpray™ over all organs under the laparotomy incision at the end of operation |
Device: Adspray
Application of AdSpray™ over all organs under the laparotomy incision at the end of operation
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| Placebo Comparator: Control Arm Spray with saline would be applied to organs under incision |
Procedure: Placebo-control
Spray with saline would be applied to organs under incision
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Outcome Measures
Primary Outcome Measures
- Incidence of adhesion [6 months]
The number of participants developed adhesion during the study period at the second operation assessment
- Extent of adhesion [6 months]
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
- Severity of adhesion [6 months]
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
Secondary Outcome Measures
- Adverse events [6 months]
Intestinal obstruction, abscess, peritonitis, surgical wound infection, malfunction of device, etc.
Eligibility Criteria
Criteria
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:
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A history of hypersensitivity to substances derived from corn starch
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A history of surgery in the abdominal cavity or pelvic cavity accompanied by a laparotomy scar
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Patients with peritonitis
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Laparoscopic assessment of adhesions may not be performed safely at the second-look surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Surgery, University of Hong Kong | Hong Kong | Hong Kong | 0000 |
Sponsors and Collaborators
- The University of Hong Kong
Investigators
- Principal Investigator: Adrian Chi Heng Fung, MBBS, The University of Hong Kong
Study Documents (Full-Text)
None provided.More Information
Publications
- Cezar C, Korell M, Tchartchian G, Ziegler N, Senshu K, Herrmann A, Larbig A, De Wilde RL. How to avoid risks for patients in minimal-access trials: Avoiding complications in clinical first-in-human studies by example of the ADBEE study. Best Pract Res Clin Obstet Gynaecol. 2016 Aug;35:84-96. doi: 10.1016/j.bpobgyn.2015.11.004. Epub 2015 Nov 14.
- Foster DS, Marshall CD, Gulati GS, Chinta MS, Nguyen A, Salhotra A, Jones RE, Burcham A, Lerbs T, Cui L, King ME, Titan AL, Ransom RC, Manjunath A, Hu MS, Blackshear CP, Mascharak S, Moore AL, Norton JA, Kin CJ, Shelton AA, Januszyk M, Gurtner GC, Wernig G, Longaker MT. Elucidating the fundamental fibrotic processes driving abdominal adhesion formation. Nat Commun. 2020 Aug 13;11(1):4061. doi: 10.1038/s41467-020-17883-1.
- Inoue M, Uchida K, Otake K, Nagano Y, Ide S, Hashimoto K, Matsushita K, Koike Y, Mohri Y, Kusunoki M. Efficacy of Seprafilm for preventing adhesive bowel obstruction and cost-benefit analysis in pediatric patients undergoing laparotomy. J Pediatr Surg. 2013 Jul;48(7):1528-34. doi: 10.1016/j.jpedsurg.2013.01.028.
- Kai M, Maeda K, Tasaki M, Kira S, Nakamura S, Chino N, Hagiwara H, Nishida H, Kawanishi T. Evaluation of a Spray-type, Novel Dextrin Hydrogel Adhesion Barrier Under Laparoscopic Conditions in a Porcine Uterine Horn Adhesion Model. J Minim Invasive Gynecol. 2018 Mar - Apr;25(3):447-454. doi: 10.1016/j.jmig.2017.09.023. Epub 2017 Oct 10.
- Lakshminarayanan B, Hughes-Thomas AO, Grant HW. Epidemiology of adhesions in infants and children following open surgery. Semin Pediatr Surg. 2014 Dec;23(6):344-8. doi: 10.1053/j.sempedsurg.2014.06.005. Epub 2014 Jun 4. Review.
- Nguyen ATM, Holland AJA. Paediatric adhesive bowel obstruction: a systematic review. Pediatr Surg Int. 2021 Jun;37(6):755-763. doi: 10.1007/s00383-021-04867-5. Epub 2021 Apr 19.
- Suto T, Watanabe M, Endo T, Komori K, Ohue M, Kanemitsu Y, Itou M, Takii Y, Yatsuoka T, Shiozawa M, Kinugasa T, Ueno H, Takayama T, Masaki T, Masuko H, Horie H, Inomata M. The Primary Result of Prospective Randomized Multicenter Trial of New Spray-Type Bio-absorbable Adhesion Barrier System (TCD-11091) Against Postoperative Adhesion Formation. J Gastrointest Surg. 2017 Oct;21(10):1683-1691. doi: 10.1007/s11605-017-3503-1. Epub 2017 Jul 25.
- Thakur M, Rambhatla A, Qadri F, Chatzicharalampous C, Awonuga M, Saed G, Diamond MP, Awonuga AO. Is There a Genetic Predisposition to Postoperative Adhesion Development? Reprod Sci. 2021 Aug;28(8):2076-2086. doi: 10.1007/s43032-020-00356-7. Epub 2020 Oct 22. Review.
- PEARLTrial