Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery
NCT ID: NCT06187558
Last Updated: 2024-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
330 participants
OBSERVATIONAL
2019-03-01
2021-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Laparoscopic Sacrohysteropexy, Modified Laparoscopic Lateral Suspension and Laparoscopic Pectopexy.
NCT04178083
Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension
NCT05586984
Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair
NCT05143658
Surgical Correction of Pelvic Organ Prolapse
NCT01182090
Comparison of 2 Techniques of Invasive Mini Surgery: Coelioscopy Mini-trocar and Monotrocar in the Adnexa no Carcinologic Surgery : Forward-looking Observational Study.
NCT02885779
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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).
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Cagliari
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Stefano Angioni
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stefano Angioni
Role: PRINCIPAL_INVESTIGATOR
University of Cagliari
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Division of Gynecology and Obstetrics Department of Surgical Sciences, University of Cagliari, Cagliari, Italy
Monserrato, Cagliari, Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LPS SUSPENSION
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.