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OpenTrials
Completed

NCT Number: NCT06622746

Endoscopic Hand Suturing After Advanced Endoscopic Resections.

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.

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Key information

Conditions

Endoscopic Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jagiellonian University

Krakow, Lesser Poland Voivodeship, 31007, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all individuals who underwent advanced endoscopic procedures followed by EHS from March 2023 to June 2024.

Exclusion criteria

  • none

Treatment and study plan

Endoscopic Hand Suturing

Procedure

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.

Primary outcomes

  1. Suturing time

    Time frame: From 1st of March 2023 to 30th of July 2024.

    The time between delivering and retrieving the needle, in minutes.

  2. Suturing speed

    Time frame: From 1st of March 2023 to 30th of July 2024.

    Calculated by dividing the longitudinal length of the defect in millimeters by the suturing time in minutes.

Secondary outcomes

  1. Postprocedural bleeding rate

    Time frame: From 1st of March 2023 to 30th of July 2024.

    The prevalence of the symptoms of gastrointestinal bleeding.

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

Endoscopic Hand Suturing After Advanced Endoscopic Resections - Early Outcomes of 31 Cases in Upper and Lower GI Tract.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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