Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometriosis
- Sponsor
- University of Cagliari
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- Safety of the Organ Suspension (OS)Technique
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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 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.
Investigators
Stefano Angioni
Professor
University of Cagliari
Eligibility Criteria
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
- •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
Exclusion Criteria
- •Surgeries conducted outside the timeframe of March 2019 to May
- •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).
Outcomes
Primary Outcomes
Safety of the Organ Suspension (OS)Technique
Time Frame: during the procedure
Incidence of OS-Related Complications: Measurement of the rate of organ-specific complications and injuries during the Organ Suspension (OS) technique.
Efficacy of the Organ Suspension (Os) Tecnique
Time Frame: During the procedure
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.
Rate of Laparotomy Conversion During OS Technique
Time Frame: during the procedure
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 (%)
Secondary Outcomes
- Postoperative Analgesic Requirement(immediately after surgery)
- Average Total Blood Loss in OS Technique(during surgery)
- Mean Duration of Hospital Stay Post-OS Technique(immediately after surgery)