The PLUG Study – A Feasibility Study Investigating the Prevention of Post-operative Gastro-oesophageal Anastomotic Leaks with the use of a Surgical Adhesive, BioGlue

Feasibility study investigating the Prevention of post-operative gastro-oesophageal anastomotic Leaks with the Use of a surgical adhesive, BioGlue – the PLUG study: a single-arm study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN26729280

Enrollment

Registered

2020-06-30

Start date

2020-03-01

Completion date

Unknown

Last updated

2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-oesophageal surgery Surgery

Interventions

SUMMARY OF STUDY DESIGN This is a feasibility study to assess the ease of use and safety of a surgical adhesive (BioGlue) to reinforce the surgical join (anastomosis) between stomach a

and we expect recruitment to be completed within 12 months. Participants will all have been booked for a minimally invasive oesophagectomy and meet inclusion/exclusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. NHS patients undergoing elective minimally invasive oesophagectomy for cancer 2. Aged 18 years and above 3. Able to provide informed consent

Exclusion criteria

Exclusion criteria: Previous adverse reaction to BioGlue or one of its constituent ingredients

Design outcomes

Primary

Measure	Time frame
The primary outcome is to assess whether it is technically feasible to apply BioGlue to the gastro-oesophageal anastomosis during oesophagectomy. This will be assessed using qualitative measures by the Operating Surgeon applying the BioGlue. These will include an overall rating describing the ease of application and a structured questionnaire addressing potential problems with the use of application of the BioGlue or laparoscopic applicator tips. Any further issues raised by the Surgeon will also be documented.	—

Measure

Time frame

The primary outcome is to assess whether it is technically feasible to apply BioGlue to the gastro-oesophageal anastomosis during oesophagectomy. This will be assessed using qualitative measures by the Operating Surgeon applying the BioGlue. These will include an overall rating describing the ease of application and a structured questionnaire addressing potential problems with the use of application of the BioGlue or laparoscopic applicator tips. Any further issues raised by the Surgeon will also be documented.

—

Secondary

Measure	Time frame
Measured at least once daily with clinical review by the surgical team up until the day of discharge, unless otherwise stated: 1. Post-operative complications up to six weeks, graded with the Clavien-Dindo scale 2. Anastomotic leak rate 3. All-cause mortality up to 6 weeks follow up 4. Operative duration 5. Time to discharge from hospital 6. Unplanned return to ITU up to 6 weeks follow up 7. Unplanned return to theatre up to 6 weeks follow up 8. Unplanned return to surgical high care unit up to 6 weeks follow up 9. Acceptability of the product to the surgeons and the theatre team (assessed using qualitative methods) 10. Number of CT scans 11. Use of antibiotics (duration, indication and type)	—

Measure

Time frame

Measured at least once daily with clinical review by the surgical team up until the day of discharge, unless otherwise stated: 1. Post-operative complications up to six weeks, graded with the Clavien-Dindo scale 2. Anastomotic leak rate 3. All-cause mortality up to 6 weeks follow up 4. Operative duration 5. Time to discharge from hospital 6. Unplanned return to ITU up to 6 weeks follow up 7. Unplanned return to theatre up to 6 weeks follow up 8. Unplanned return to surgical high care unit up to 6 weeks follow up 9. Acceptability of the product to the surgeons and the theatre team (assessed using qualitative methods) 10. Number of CT scans 11. Use of antibiotics (duration, indication and type)

—

Countries

England, United Kingdom

Contacts

Public ContactIan Gedge

ian.gedge@porthosp.nhs.uk+44 (0)2392 826 236

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026