An observational study in Endoscopic Surgical Procedures, sponsored by Jagiellonian University. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by Jagiellonian University · Observational
Endoscopic hand-suturing (EHS) has emerged as a promising modality in gastrointestinal (GI) endoscopic procedures. The available reports regarding its effectiveness in clinical practice are limited due to the relatively recent expansion of this method. This study aims to describe the single-center experience of EHS and its outcomes.
Endoscopic hand-suturing (EHS) has emerged as a promising modality in gastrointestinal (GI) endoscopic procedures. The available reports regarding its effectiveness in clinical practice are limited due to the relatively recent expansion of this method. This study aims to describe the single-center experience of EHS and its outcomes. The retrospective single-center study included individuals that underwent advanced endoscopic procedures in upper and lower GI tract followed by EHS. Defined features (suturing time, suturing speed) and outcomes (postprocedural bleeding, abdominal pain) were assessed. Thirty-one patients were included in the analysis.
Jagiellonian University is the lead sponsor of 156 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This retrospective single-center study included all individuals who underwent advanced endoscopic procedures followed by EHS from March 2023 to June 2024. Procedures were conducted both in the upper and lower GI tract and included endoscopic intermuscular dissection (EID), endoscopic mucosal resection (EMR), ESD, EFTR, POEM, and STER. The EHS was performed to close a GI wall defect (after EMR, ESD, or EID) or the linear entry mucosal incision (after POEM or STER). The indications for additional suturing were high risk of bleeding following ESD in upper GI (based on patients' history of anticoagulant therapy and advanced age), closing the deep wall defect after EID in the rectum to improve recovery, closing the full-thickness defect after EFTR in cases of submucosal lesions, and concurrent treatment for perforation during ESD.
Exclusion Criteria:
All individuals who underwent advanced endoscopic procedures followed by EHS from March 2023 to June 2024
Procedure: Endoscopic Hand Suturing
Endoscopic Hand Suturing is a technique of the wound closure after advanced endoscopic third-space resections I the upper and lower gastrointestinal tract. In this technique, the needle is held on the opposite side from the tip with the needle holder. The needle is pierced perpendicularly into the tissue at the side of the wound with an appropriate margin, then driven through the tissue with rotation and grasped at the bottom of the defect. The same steps are repeated from the middle of the wound to create a symmetrical structure.
Suturing time
The time between delivering and retrieving the needle, in minutes.
Time frame: From 1st of March 2023 to 30th of July 2024.
Suturing speed
Calculated by dividing the longitudinal length of the defect in millimeters by the suturing time in minutes.
Time frame: From 1st of March 2023 to 30th of July 2024.
Postprocedural bleeding rate
The prevalence of the symptoms of gastrointestinal bleeding.
Time frame: From 1st of March 2023 to 30th of July 2024.
Plan to share: Undecided — We intend to share the encrypted data with other investigators after appropriate application and approval of the study chair.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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