Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06187558
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2023-10-25
Brief Title:
Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery
Sponsor:
University of Cagliari
Organization:
University of Cagliari
Study Overview
Official Title:
Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this retrospective observational study is to evaluate the efficacy safety and practicality of an organ suspension technique with adjustable tension suture in facilitating minimally invasive gynecologic surgeries at the University Hospital of Cagliari Italy The main questions it aims to answer are
Is the organ suspension technique using adjustable tension suture both cost-effective and practical for minimally invasive gynecologic surgeries
How safe effective and feasible is this suspension technique when applied to patients with benign or malignant gynecological diseases undergoing laparoscopic surgery
Participants in this study underwent laparoscopic surgery involving the organ suspension technique which includes
The use of a modified Foley catheter and Polyglactin suture for organ suspension
The collection of preoperative and postoperative data such as operation times blood loss hospital stay duration and short-term postoperative complications
This study does not include a comparison group focusing instead on the direct outcomes and experiences of the participants who underwent the specified surgical technique
Is the organ suspension technique using adjustable tension suture both cost-effective and practical for minimally invasive gynecologic surgeries
How safe effective and feasible is this suspension technique when applied to patients with benign or malignant gynecological diseases undergoing laparoscopic surgery
Participants in this study underwent laparoscopic surgery involving the organ suspension technique which includes
The use of a modified Foley catheter and Polyglactin suture for organ suspension
The collection of preoperative and postoperative data such as operation times blood loss hospital stay duration and short-term postoperative complications
This study does not include a comparison group focusing instead on the direct outcomes and experiences of the participants who underwent the specified surgical technique
Detailed Description:
This retrospective observational study conducted at the University Hospital of Cagliari in Italy is focused on providing a comprehensive evaluation of an innovative organ suspension OS technique using an adjustable tension suture in minimally invasive gynecologic surgery The primary aim of the study is to determine the safety efficacy and feasibility of this technique especially in the context of both benign and malignant gynecological diseases
The OS technique is characterized by its unique use of a 2 cm segment of a 1 FrCh Foley catheter which is tied at the end of an absorbable 2-0 Polyglactin suture equipped with a straight needle This assembly is strategically inserted into the pelvic cavity through an ancillary port The primary function is to suspend critical organs such as the ovary posterior peritoneum vesico-uterine peritoneum or bowel facilitating better surgical access and maneuverability The suture once in place is retrieved and pulled through the abdominal wall positioning the Foley catheter such that it faces the surface of the suspended organ This setup is secured using a Kelly clamp without a knot allowing the surgeon to adjust the tension of the suspension as required during the surgery
The studys participants comprise patients who underwent laparoscopic surgery for various gynecological conditions including benign issues like endometriosis and pelvic prolapse as well as malignant diseases such as endometrial cancer The data collection for these participants is twofold preoperative and postoperative Preoperatively the study gathers information on age clinical history symptoms the location of the pathology operation times and blood loss Postoperatively the focus shifts to the number of days of hospital stay and the incidence of short-term postoperative complications defined as those occurring within 30 days of the surgery
By thoroughly analyzing this data the study aims to answer critical questions regarding the cost-effectiveness practicality safety and effectiveness of the OS technique This could potentially lead to significant advancements in the field of minimally invasive gynecologic surgery offering insights into more effective and patient-friendly surgical approaches
The OS technique is characterized by its unique use of a 2 cm segment of a 1 FrCh Foley catheter which is tied at the end of an absorbable 2-0 Polyglactin suture equipped with a straight needle This assembly is strategically inserted into the pelvic cavity through an ancillary port The primary function is to suspend critical organs such as the ovary posterior peritoneum vesico-uterine peritoneum or bowel facilitating better surgical access and maneuverability The suture once in place is retrieved and pulled through the abdominal wall positioning the Foley catheter such that it faces the surface of the suspended organ This setup is secured using a Kelly clamp without a knot allowing the surgeon to adjust the tension of the suspension as required during the surgery
The studys participants comprise patients who underwent laparoscopic surgery for various gynecological conditions including benign issues like endometriosis and pelvic prolapse as well as malignant diseases such as endometrial cancer The data collection for these participants is twofold preoperative and postoperative Preoperatively the study gathers information on age clinical history symptoms the location of the pathology operation times and blood loss Postoperatively the focus shifts to the number of days of hospital stay and the incidence of short-term postoperative complications defined as those occurring within 30 days of the surgery
By thoroughly analyzing this data the study aims to answer critical questions regarding the cost-effectiveness practicality safety and effectiveness of the OS technique This could potentially lead to significant advancements in the field of minimally invasive gynecologic surgery offering insights into more effective and patient-friendly surgical approaches
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None