EndometriosisNCT06187558
Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery
An observational study of Endometriosis and Pelvic Prolapse, run by University of Cagliari at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometriosis, Pelvic Prolapse, Endometrium Cancer
- What is being tested?
- Pelvic and abdominal organ suspension technique
- Type of treatment
- Surgery or procedure
- How many people
- 330 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2019to 30 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- 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:
Show all 11Show fewer
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Division of Gynecology and Obstetrics Department of Surgical Sciences, University of Cagliari, Cagliari, Italy
Monserrato, Cagliari, 09042
About this study
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?
Read more
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.
Read the 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.
- Conditions
- Endometriosis, Pelvic Prolapse, Endometrium Cancer
- Being tested
- Pelvic and abdominal organ suspension technique
- Keywords
- Organ Suspension Techniques, Ovariopexy, Laparoscopic
- Medical subject headings
- Endometriosis, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic and abdominal organ suspension techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Pelvic and abdominal organ suspension technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 (%)
Measured: during the procedure
Secondary outcomes (3)
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)
Measured: during surgery
Postoperative Analgesic Requirement
Postoperative analgesic drug management in patients undergoing OS technique. Unit of Measure: Analgesic dosage (mg) and frequency of administration
Measured: immediately after surgery
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
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start1 Mar 2019
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Angioni, University of Cagliari
- Investigators
- Stefano Angioni, Principal investigator, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187558
- Sponsor's protocol ID
- LPS SUSPENSION
- Status last verified
- Dec 2023
- First submitted
- 25 Oct 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28545294Chaichian 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.
PubMed 35148732Chatzipapas 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.
PubMed 34840798Thompson 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.
PubMed 34015526Abuzeid 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.
PubMed 31110645
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suspension of the Pelvic and Abdominal Organs During Minimally Invasive Surgery
- ClinicalTrials.gov ID
- NCT06187558
- Acronym / sponsor ID
- LPS SUSPENSION
- Conditions
- Endometriosis, Pelvic Prolapse, Endometrium Cancer
- Keywords
- Organ Suspension Techniques, Ovariopexy, Laparoscopic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic Organ Suspension Patients | – | Procedure: Pelvic and abdominal organ suspension techniqueThis 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic and abdominal organ suspension techniqueThe 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. | Procedure or surgery | Pelvic Organ Suspension Patients |
Primary outcome
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 (%)
3 secondary outcomes
Average Total Blood Loss in OS Technique
Time frame: during surgery
Postoperative Analgesic Requirement
Time frame: immediately after surgery
Mean Duration of Hospital Stay Post-OS Technique
Time frame: immediately after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Background: PubMed 28545294Angioni 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.
- Background: PubMed 35148732Chaichian 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.
- Background: PubMed 34840798Chatzipapas 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.
- Background: PubMed 34015526Thompson 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.
- Background: PubMed 31110645Abuzeid 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Angioni principal investigator
University of Cagliari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Pelvic Prolapse, run by University of Cagliari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the Organ Suspension (OS)Technique (time frame: during the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06187558, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.