Seal-G/ Seal-G MIST Long-Term Follow-up PMCF (Continue) Study
ConditionColon Anastomosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorAdvanced Medical Solutions Ltd.
About this trial
Postoperative complications following colon anastomosis surgery, such as adhesions, stenosis, stricture and obstruction, can significantly impact patient outcomes. The use of surgical sealants has been proposed as a means to mitigate anastomotic complications by providing a protective barrier over the anastomosis site, reducing the risk or the severity of anastomotic leak. The previous post-market clinical follow-up (PMCF) study assessed the short-term safety and performance of SEAL-G surgical sealants in preventing anastomotic leaks and early post-operative complications. However, long-term data are needed to establish its sustained safety and effectiveness.
This continuation study aims to evaluate the long-term impact of the SEAL-G/MIST surgical sealant on post-operative complications over 12+ months after surgery. The study will compare complication rates in patients treated with the surgical sealant to a retrospective comparable control group who underwent similar procedures without the sealant.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Treatment Group: Patients participated and completed all visits in the previous PMCF study (treatment group; #DLG-072-06)
Control Group: comparable retrospective subjects that meet the same inclusion criteria specified in #DLG-072-06.
Disqualifiers
Patients with missing or incomplete medical records that prevent retrospective comparison.
Patients that during the original surgery received any treatment on the anastomosis (sealant/glue) except for the anastomosis closure technique (sutures/staple).
Original surgery included stoma creation.
Trial population
For the Retrospective Treatment Group, 3 out of the 8 sites participated in the previous PMCF study (#DLG-072-06), will be included with a total of 104 patients who received the Seal-G / Seal-G MIST surgical sealant during colon anastomosis surgery 2-4 years ago (during 2021-2023). The following sites were selected due to relatively large number of participants in the previous study and according to their ability to comply with the current study procedures. For the Retrospective Control group, screening will be performed at each site, for a matching number of subjects from a comparable population (i.e age; BMI; surgery procedure (2-4 years ago); etc.) that did not receive the sealant treatment.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
long-term follow up visit
Other interventionPhone call questionnaire- retrospective treatment arm Phone call questionnaire- retrospective control arm
Treatment groups
208 Participants
are divided into 2 treatment groupsGroup A: Retrospective Treatment Group1 intervention
Group B: Retrospective Control Group1 intervention
Trial outcomes
Primary outcomes
1
Rate of reoperation due to anastomotic complications
Time frame
1 year post-surgery2
Assessment of long-term anastomotic complications (i.e. adhesions, stenosis, stricture, and obstruction)
At least one complication within the 1 year interval
Time frame
1 year post-surgerySecondary outcomes
1
The incidence of anastomotic complications (i.e. adhesions, stenosis, stricture, and obstruction)
Time frame
1-4 years post-surgery2
The incidence of hospitalization due to anastomotic complications
Time frame
1-4 years post-surgery3
The incidence of reoperation due to anastomotic complications
Time frame
1-4 years post surgery4
The incidence of anastomotic leaks (Clinical/sub-clinical)
Time frame
30 day post surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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