Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery

Endometriosis Clinical Trial

Official title:

Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06187558
• Other study ID #: LPS SUSPENSION
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: May 30, 2021

Study information

• Verified date: December 2023
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Endometriosis
• Endometrium Cancer
• Pelvic Prolapse
• Prolapse

Intervention

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.

Locations

Country	Name	City	State
Italy	Division of Gynecology and Obstetrics Department of Surgical Sciences, University of Cagliari, Cagliari, Italy	Monserrato	Cagliari

Sponsors (1)

Lead Sponsor	Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Abuzeid OM, Hebert J, Ashraf M, Mitwally M, Diamond MP, Abuzeid MI. Safety and efficacy of two techniques of temporary ovarian suspension to the anterior abdominal wall after operative laparoscopy. Facts Views Vis Obgyn. 2018 Jun;10(2):71-79. — View Citation

Angioni S. New insights on endometriosis. Minerva Ginecol. 2017 Oct;69(5):438-439. doi: 10.23736/S0026-4784.17.04089-8. Epub 2017 May 25. No abstract available. — View Citation

Chaichian S, Saadat Mostafavi SR, Mehdizadehkashi A, Najmi Z, Tahermanesh K, Ahmadi Pishkuhi M, Jesmi F, Moazzami B. Hyaluronic acid gel application versus ovarian suspension for prevention of ovarian adhesions during laparoscopic surgery on endometrioma: a double-blind randomized clinical trial. BMC Womens Health. 2022 Feb 11;22(1):33. doi: 10.1186/s12905-022-01607-2. — View Citation

Chatzipapas I, Kathopoulis N, Kypriotis K, Samartzis K, Siemou P, Protopapas A. A simple technique for suspension and stabilization of retrieval bag and adnexa by anchoring to the abdominal wall. Clin Case Rep. 2021 Nov 19;9(11):e05056. doi: 10.1002/ccr3.5056. eCollection 2021 Nov. — View Citation

Thompson R, Cesta M, Pasic R. Improved Exposure in Minimally Invasive Excision of Endometriosis with Temporary Ovarian Suspension Using Carter-Thomason CloseSure System, a Novel Technique. J Minim Invasive Gynecol. 2021 Oct;28(10):1678. doi: 10.1016/j.jmig.2021.05.004. Epub 2021 May 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the Organ Suspension (OS)Technique	Incidence of OS-Related Complications: Measurement of the rate of organ-specific complications and injuries during the Organ Suspension (OS) technique.	during the procedure
Primary	Efficacy of the Organ Suspension (Os) Tecnique	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.	During the procedure
Primary	Rate of Laparotomy Conversion During OS Technique	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 (%)	during the procedure
Secondary	Average Total Blood Loss in OS Technique	Measurement of the average total blood loss during surgery using the OS technique. Unit of Measure: Milliliters (ml)	during surgery
Secondary	Postoperative Analgesic Requirement	Postoperative analgesic drug management in patients undergoing OS technique. Unit of Measure: Analgesic dosage (mg) and frequency of administration	immediately after surgery
Secondary	Mean Duration of Hospital Stay Post-OS Technique	Evaluation of the mean duration of hospital stay post-surgery, with significant differences highlighted based on the indication for surgery. Unit of Measure: Days	immediately after surgery