Surgical AdhesionsPEARLNCT05255081
Evaluating Clinical Effects of a Spray-Type Bio-absorbable Adhesion Barrier System in Paediatric Patients
A study testing Adspray in people with Surgical Adhesions, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Surgical Adhesions
- What is being tested?
- Adspray
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients requiring laparotomy and staged operation with closure of stoma as second operation e.g. Necrotising Enterocolitis, Anorectal malformation, Hirschsprung's disease, etc.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Surgery, University of Hong Kong
Hong Kong, 0000
About this study
Official title: 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
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.
Read the 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.
- Study objective To investigate the effect of a novel spray-type, novel dextrin hydrogel adhesion barrier (AdSpray™; Terumo Corporation, Tokyo, Japan) on postsurgical adhesions.
- 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.
- Conditions
- Surgical Adhesions
- Being tested
- Adspray, Placebo-control
- Keywords
- Paediatric surgery, surgical adhesions, medical device, biodegradable anti-adhesive agent
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdsprayDevice
Application of AdSpray™ over all organs under the laparotomy incision at the end of operation
Placebo-controlProcedure or surgery
Spray with saline would be applied to organs under incision
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Application of AdSpray™ over all organs under the laparotomy incision at the end of operation Receives: Device: Adspray |
| Control Arm | Placebo comparator | Spray with saline would be applied to organs under incision Receives: Procedure: Placebo-control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adhesion
The number of participants developed adhesion during the study period at the second operation assessment
Measured: 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
Measured: 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
Measured: 6 months
Secondary outcomes (1)
Adverse events
Intestinal obstruction, abscess, peritonitis, surgical wound infection, malfunction of device, etc.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Mar 2022
- Primary completion1 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Surgical AdhesionsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian Chi Heng Fung, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255081
- Sponsor's protocol ID
- PEARLTrial
- Acronym
- PEARL
- Status last verified
- May 2023
- First submitted
- 4 Feb 2022
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33090376Foster 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.
PubMed 32792541Lakshminarayanan 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.
PubMed 25459439Nguyen 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.
PubMed 33876300Inoue 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.
PubMed 23895967Kai 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.
PubMed 29030291Suto 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.
PubMed 28744742Cezar 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.
PubMed 26707194
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05255081
- Acronym / sponsor ID
- PEARL / PEARLTrial
- Conditions
- Surgical Adhesions
- Keywords
- Paediatric surgery, surgical adhesions, medical device, biodegradable anti-adhesive agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
- Study objective To investigate the effect of a novel spray-type, novel dextrin hydrogel adhesion barrier (AdSpray™; Terumo Corporation, Tokyo, Japan) on postsurgical adhesions.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: AdsprayApplication of AdSpray™ over all organs under the laparotomy incision at the end of operation |
| Control Arm | Placebo comparator | Procedure: Placebo-controlSpray with saline would be applied to organs under incision |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients requiring laparotomy and staged operation with closure of stoma as second operation e.g. Necrotising Enterocolitis, Anorectal malformation, Hirschsprung's disease, etc.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdsprayApplication of AdSpray™ over all organs under the laparotomy incision at the end of operation | Device | Treatment Arm |
| Placebo-controlSpray with saline would be applied to organs under incision | Procedure or surgery | Control Arm |
Primary outcome
Incidence of adhesion
Time frame: 6 months
The number of participants developed adhesion during the study period at the second operation assessment
Extent of adhesion
Time frame: 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
Time frame: 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
1 secondary outcome
Adverse events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 33090376Thakur 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.
- Background: PubMed 32792541Foster 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.
- Background: PubMed 25459439Lakshminarayanan 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.
- Background: PubMed 33876300Nguyen 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.
- Background: PubMed 23895967Inoue 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.
- Background: PubMed 29030291Kai 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.
- Background: PubMed 28744742Suto 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.
- Background: PubMed 26707194Cezar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Chi Heng Fung, MBBS principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adspray in people with Surgical Adhesions, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adhesion (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05255081, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.