Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery

NCT06187558 | Completed

• 1 other identifier: LPS SUSPENSION
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Pelvic Prolapse; Endometrium Cancer

Keywords

Organ Suspension Techniques; Ovariopexy; Laparoscopic

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Average Total Blood Loss in OS Technique

  during surgery

• Postoperative Analgesic Requirement

  immediately after surgery

• Mean Duration of Hospital Stay Post-OS Technique

  immediately after surgery

Study Arms (1)

Pelvic Organ Suspension Patients

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.

Procedure: Pelvic and abdominal organ suspension technique

Interventions

Pelvic and abdominal organ suspension technique PROCEDURE

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 Organ Suspension Patients

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprised female patients who attended the University Hospital of Cagliari, a tertiary referral hospital. They underwent either multiport or single-site-port laparoscopic surgeries. The study retrospectively observed a total of 330 patients who had their surgeries between March 2019 and May 2021. Patients underwent surgery due to: Deep infiltrating endometriosis (DIE) Oncological disease Pelvic prolapse treated by laparoscopic surgical procedure Single-port access laparoscopy for benign gynecological diseases (SPAL)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

Division of Gynecology and Obstetrics Department of Surgical Sciences, University of Cagliari, Cagliari, Italy

Monserrato, Cagliari, 09042, Italy

Location

Related Publications (5)

• 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.

  PMID: 28545294 BACKGROUND

• 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.

  PMID: 35148732 BACKGROUND

• 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.

  PMID: 34840798 BACKGROUND

• 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.

  PMID: 34015526 BACKGROUND

• 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.

  PMID: 31110645 BACKGROUND

MeSH Terms

Conditions

Endometriosis; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases

Study Officials

• Stefano Angioni

  University of Cagliari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: January 2, 2024
• Study Start: March 1, 2019
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)