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Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery

NCT06187558 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2024-01-02

No results posted yet for this study

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.

Conditions

  • Endometriosis
  • Pelvic Prolapse
  • Endometrium Cancer

Interventions

PROCEDURE

Pelvic and abdominal organ suspension technique

The intervention involves a unique organ suspension technique tailored for minimally invasive gynecologic surgeries. A fragment of a Foley catheter (2 cm of a 1 Fr/Ch) is tied at the end of an absorbable 2-0 Polyglactin suture with a straight needle to create the suspension device. This suture is introduced into the pelvic cavity via an ancillary port. It's designed to penetrate organs such as the ovary, posterior peritoneum, vesico-uterine peritoneum, or bowel. Once the suture is retrieved by passing it through the abdominal wall and pulled so that the Foley segment faces the organ's surface, it's secured using a Kelly clamp. This setup eliminates the need for a knot and offers the surgeon the flexibility to adjust the suspension tension as required.

Sponsors & Collaborators

  • University of Cagliari

    lead OTHER

Principal Investigators

  • Stefano Angioni · University of Cagliari

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2021-05-30
Completion
2021-05-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06187558 on ClinicalTrials.gov