Seal-G/ Seal-G MIST Long-Term Follow-up PMCF (Continue) Study

Официальное название

Long-Term Safety and Efficacy Evaluation of Seal-G and Seal-G MIST Surgical Sealants for Anastomosis Protection in Colon Surgery [PMCF Study Continuation]

Обзор

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.

Подробное описание

The study is designed as an observational, retrospective-controlled, long-term follow-up, multi-center post-market clinical follow-up (PMCF) study.

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. Phone Questionnaire: Long-term follow-up visit should be performed via Phone call Questionnaire. Patients will be contacted (including Oral informed consent) to assess long-term outcomes relating to the colon anastomosis surgery they underwent 2-4 years ago.

* Incidence of adhesions, stenosis, and obstruction (reported during the Physician questionnaire and confirmed by medical records review where possible). * Need for reoperation due to complications. * Use of additional treatments relating to anastomosis complications (e.g., anti-adhesion therapy, bowel obstruction management).

Вмешательства

• Другое long-term follow up visit
  Phone call questionnaire- retrospective treatment arm Phone call questionnaire- retrospective control arm

Первичные конечные точки

• Rate of reoperation due to anastomotic complications [Срок оценки: 1 year post-surgery]
• Assessment of long-term anastomotic complications (i.e. adhesions, stenosis, stricture, and obstruction) [Срок оценки: 1 year post-surgery]

Вторичные конечные точки (4)

• The incidence of anastomotic complications (i.e. adhesions, stenosis, stricture, and obstruction) [Срок оценки: 1-4 years post-surgery]
• The incidence of hospitalization due to anastomotic complications [Срок оценки: 1-4 years post-surgery]
• The incidence of reoperation due to anastomotic complications [Срок оценки: 1-4 years post surgery]
• The incidence of anastomotic leaks (Clinical/sub-clinical) [Срок оценки: 30 day post surgery]

Критерии участия

Критерии включения

• 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.
• Both Treatment \& Control group:

Willing to comply with long-term follow-up assessment (including oral consent).

Критерии исключения

• Both Treatment \& Control group:

Patients who are unable or unwilling to complete the phone questionnaire.

\- Control group: Subjects that would have been excluded according to the previous PMCF study #DLG-072-06 exclusion criteria.

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07100886 · DLG-072-13

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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