Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery

University of Cagliari

Status: Completed

Conditions: Pelvic Prolapse; Endometrium Cancer; Endometriosis

Treatments: Procedure: Pelvic and abdominal organ suspension technique

Study type: Observational

Funder types: Other

Identifiers

NCT06187558

LPS SUSPENSION

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 330 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who underwent multiport or single-site-port laparoscopic surgery with at least one transient pelvic organ suspension.
• Surgeries performed between March 2019 and May 2021.
• Surgeries conducted in the specified tertiary referral hospital.
• Patients who provided written informed consent for the surgical procedure and for the use of their personal data in scientific research.
• Availability of medical records and videos of surgeries for data collection.
• Patients who underwent surgery for one of the following conditions:
• Deep infiltrating endometriosis (DIE)
• Endometrial Cancer
• Pelvic prolapse treated by laparoscopic surgical procedure
• Single-port access laparoscopy for benign gynecological diseases
• Surgeries performed by either senior surgeon (S.A.) or junior surgeon (M.N.D).

Exclusion criteria

• Surgeries conducted outside the timeframe of March 2019 to May 2021.
• Surgeries not involving multiport or single-site-port laparoscopic surgery with pelvic organ suspension.
• Patients who did not provide written informed consent.
• Absence of medical records or surgery videos for data collection.
• Surgeries not performed in the mentioned tertiary referral hospital.
• Surgeries not primarily conducted for the specified indications (i.e., DIE, oncological disease, pelvic prolapse).
• Surgeries not performed by the listed surgeons (S.A. or M.N.D).

Trial design

330 participants in 1 patient group

Pelvic Organ Suspension Patients

Description:

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.

Treatment:

Procedure: Pelvic and abdominal organ suspension technique