Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Prolapse

Endometriosis

Endometrial Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Pathological Conditions, Anatomical

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

This group comprises patients who have undergone multiport or single-port access laparoscopic surgery (SPAL) at the Tertiary referral University Hospital of Cagliari, Italy. These patients suffer from benign (like endometriosis, pelvic prolapse) or malignant (like endometrial cancer) gynecological diseases. During their surgery, they have experienced at least one instance of the described pelvic organ suspension technique using an adjustable tension suture tied to a Foley catheter fragment for organ suspension.

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.

Pelvic and abdominal organ suspension technique

Stefano Angioni

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.

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 Fr/Ch 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 study's 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.

Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery

Incidence of OS-Related Complications: Measurement of the rate of organ-specific complications and injuries during the Organ Suspension (OS) technique.

Time required to achieve transient organ suspension, with comparison across organ types, surgeon experience levels, and patient BMI categories. Unit of Measure: Minutes to achieve suspension.

This measure assesses the frequency of conversion from the Organ Suspension (OS) technique to open laparotomy during surgery. The focus is to quantify how often the intended OS procedure is converted to a traditional laparotomy, indicating challenges or complications with the OS technique. Unit of Measure: Percentage of surgeries converted to laparotomy (%)

Measurement of the average total blood loss during surgery using the OS technique. Unit of Measure: Milliliters (ml)

Postoperative analgesic drug management in patients undergoing OS technique. Unit of Measure: Analgesic dosage (mg) and frequency of administration

Evaluation of the mean duration of hospital stay post-surgery, with significant differences highlighted based on the indication for surgery. Unit of Measure: Days

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery	NCT06187558	Endometriosis Pelvic Prolapse Endometrium Can...	Pelvic and abdo...	-	University of Cagliari
Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery	NCT06187558	Endometriosis Pelvic Prolapse Endometrium Can...	Pelvic and abdo...	-	University of Cagliari
Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery	NCT06187558	Endometriosis Pelvic Prolapse Endometrium Can...	Pelvic and abdo...	-	University of Cagliari

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