Effectiveness of full-thickness resection in the colon using the Pro-select Padlock clip

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON28053

Enrollment

Registered

2016-01-14

Start date

2015-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

full-thickness resection FTR recurrent fibrosed adenoma

Interventions

Endoscopic full-thickness resection with the ProSelect PadLock clip in the colon.

Eligibility

Inclusion criteria

Inclusion criteria: • ≥18 years old • informed consent • Indication for full-thickness resection: recurrent fibrosed adenoma, adenoma located in diverticula, SET of the colon, Rx/R1 endoscopic resection of a T1 CRC

Exclusion criteria

Exclusion criteria: • Target lesions > 20 mm

Design outcomes

Primary

Measure	Time frame
• R0-resection rate [Timepoint: 2 weeks] • Full-thickness resection rate [Timepoint: 2 weeks] • Complication rate [Timepoint: 30 days]	—

Secondary

Measure	Time frame
• Recurrence at 6 months follow-up [Timepoint: 6 months] • Patients experience 7 days after resection [Timepoint: 7 days] • Patients experience 30 days after resection [Timepoint: 30 days]	—

Contacts

Public ContactYara Backes

Divisie Interne Geneeskunde en Dermatologie, MDL, UMCU

Y.Backes@umcutrecht.n+31 88 75 507 22

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)