An interventional study of vaginal hysterectomy by bipolar vessels sealing and vaginal hysterectomy by traditional technique in Pelvic Organ Prolapse, Gynecologic Disorders and Surgery, sponsored by IRCCS San Raffaele. Not yet recruiting at 1 site in Italy. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by IRCCS San Raffaele · Not applicable, Interventional, and Other
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Among 13 studies in Pelvic Organ Prolapse with a site in Italy — 3 open to participants now, 3 under way, none of them phase 3. Pelvic Organ Prolapse · Italy.
Among the 13 studies in Pelvic Organ Prolapse with a site in Italy, this one is the 8th largest by planned enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2024, is one of 8 with no phase, and was the 12th registered.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
Browse Pelvic Organ Prolapse studies →3 of the 13 studies in Pelvic Organ Prolapse with a site in Italy are open now. Recruiting first, the newest first:
Ethicon, Inc. · Sites in Italy, United States, Austria and 4 more countries
Ages 21+ · Women only
IRCCS San Raffaele · Sites in Italy
Ages 45–80 · Women only
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 53 Pelvic Organ Prolapse studies recruiting now, 31 (58%) set no upper age limit and 10 (19%) stop at 75 or younger; 2 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
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13 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2024.
This study's planned enrollment of 60 is below the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.
Median enrollment 64 across the 11 interventional studies, 600 across the 2 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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1 of 13 have an industry lead sponsor. The 6 most frequent:
IRCCS San Raffaele is the lead sponsor of 454 studies on the registry; 235 are open to participants now.
IRCCS San Raffaele has 3 studies filed under Pelvic Organ Prolapse — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Pelvic Organ Prolapse with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Randomized prospective monocentric interventional study to compare learning curves for traditional vaginal hysterectomy and vaginal hysterectomy performed by bipolar coagulation comparing short-term outcomes for both procedures.
This is a prospective, randomized, spontaneous monocentric interventional study on a procedure in which 60 female patients will be enrolled with a diagnosis of pelvic organs prolapse which are eligible for vaginal hysterectomy. The data relating to the intervention will be collected, analyzed and compared through a descriptive statistics.
Patients will be randomized 1:1 in two groups:
Secondary outcomes are to evaluate the effectiveness of the two different procedures through the evaluation of short-term outcomes for both procedures under consideration.
The planned duration of recruitment will be 7 months. In this period of time it is planned to enrol a total of 60 patients. Once the learning curve plateau has been reached for both procedures, the study will be considered finished. The number of samples was chosen on the basis of the feasibility of recruitment and the possibility of evaluating the learning curve of the operators.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The surgery will take place according to the canonical times of vaginal hysterectomy, after incision of the portio, detachment of the bladder-vaginal fascia and vaginal rectum, opening of the anterior and posterior peritoneum, taking, section and ligament of the ligaments uterus-sacral ligaments, and subsequent coagulation by bipolar instrument of the other structures of the uterus and their section, in particular of the uterine arteries, tubes, uterine-ovarian ligaments and round ligament bilaterally.
Procedure: vaginal hysterectomy by bipolar vessels sealing
The surgery will take place according to the canonical times of vaginal hysterectomy, after incision of the port, detachment of the bladder-vaginal fascia and vaginal rectum, opening of the anterior and posterior peritoneum, taking and suturing with absorbable threads of all the support structures of the uterus, in particular uterus-sacral ligaments, uterine arteries, tubes, uterine-ovarian ligaments and round ligament bilaterally.
Procedure: vaginal hysterectomy by traditional technique
The surgery will take place according to the canonical times of vaginal hysterectomy and all the support structures will be coagulated and cut by a bipolar vessel sealing instrument
The surgery will take place according to the canonical times of vaginal hysterectomy and all the support structures will be sutured by absorbable threads
Learning curve comparison
The primary objective of the study is to compare the learning curves (in terms of operating time, blood loss, intraoperative complications) for two vaginal surgical techniques for hysterectomy performed for the treatment of prolapse of the pelvic organs in women. The two procedures compared will be the traditional technique performed by applying reabsorbable sutures and the bipolar coagulation technique.
Time frame: immediate post operative time
Evaluate the effectiveness of the two different techniques of vaginal hysterectomy.
Effectiveness will be assessed in terms of short-term outcomes such as: Intraoperative complications post-operative pain inpatient time Post-operative urinary infections vaginal infections, postoperative collected hematomas
Time frame: 3 days after the surgical procedure
Start is estimated for Jun 2024; primary completion for Mar 2025, 9 months later.
Of 162 non-industry interventional studies with no phase under Pelvic Organ Prolapse, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 9 months is below that.
Counting every sponsor, half of 179 studies reached it within 23 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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