An interventional study of Changes in preoperative care and Changes in intraoperative care in Surgery, Hysterectomy and Gynecologic Disease, sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia. Completed at 1 site in Italy. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-07.
Sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Not applicable, Interventional, and Treatment
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Among 11 studies in Genital Diseases, Female with a site in Italy — 6 open to participants now, 6 under way, none of them phase 3. Genital Diseases, Female · Italy.
Among the 11 studies in Genital Diseases, Female with a site in Italy, this one is the only one that started in 2017, is one of 3 with no phase, and was the 4th registered.
161 studies on the registry are indexed under Genital Diseases, Female; 31 are open to participants now.
Browse Genital Diseases, Female studies →6 of the 11 studies in Genital Diseases, Female with a site in Italy are open now. Recruiting first, the newest first:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
Ages 18+ · Women only
SCHETTINI SERGIO · Sites in Italy
Ages 20–50 · Women only
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
Ages 18–75 · Women only
IRCCS San Raffaele · Sites in Italy
Healthy volunteers
IRCCS Azienda Ospedaliero-Universitaria di Bologna · Sites in Italy
Ages 18+ · 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 21 Genital Diseases, Female studies recruiting now, 10 (48%) set no upper age limit and 11 (52%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 75 Years · female · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 166 is above the median of 78 across 119 interventional studies indexed under Genital Diseases, Female.
Median enrollment 60 across the 5 interventional studies, 1,033 across the 6 observational. Of the 4 that completed or were terminated, 1 (25%) have results posted.
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1 of 11 have an industry lead sponsor. The 9 most frequent:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia has 1 study filed under Genital Diseases, Female — fewer than ten, so there is no comparison to draw.
1 of the studies in Genital Diseases, Female with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07031921Fondazione Policlinico Universitario Agostino Gemelli IRCCSUltrasound Image Bank: Advancing Medical Research and Diagnostics | 2026-12-30 |
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Among the 11 studies in Genital Diseases, Female with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Validation of ERAS interventional measures in elective gynecological surgery, for benign either malignant pathology.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Changes in preoperative care · Other: Changes in intraoperative care · Other: Changes in postoperative care
Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling
Blended anesthesia is mostly carried out using Total Intra Venous Anesthesia (TIVA) with loco regional analgesia, in particular Thoracic Epidural Anesthesia (TEA) in open surgery and spinal morphine or Transversus Abdominis Plane (TAP) block or quadratus lumborum block for laparoscopic surgical approach, associated to NSAIDs or acetaminophen; control of deep neuromuscular blocking with Train-of-four (TOF) stimulation avoiding residual paralysis. Multimodal prevention of PONV (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs.
Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV. According to the type of surgery TEA, TAP block , quadratus lumborum block or IT morphine is preferred. Patient is proposed to start drinking clear fluid 4 hours after surgery and to start eating the evening of the surgery, with the introduction of a normal free diet within 24 hours after surgery. It is proposed to chew gum three times daily for at least 15 minutes and eventually to use laxatives to promote a faster bowel function. Early mobilization is started from the evening of surgery.
Shorter Length Of Hospitalization (LOH)
Total amount of days spent in hospital
Time frame: Up to 4 weeks after surgery
Assessment of postoperative pain
NRS scale (from 0 to 10, 0 is no pain, 10 is maximum pain)
Time frame: At moment 0, 3, 6, 12 and 24 hours after surgery
Presence/Absence of nausea
Time frame: At moment 0, 3, 6, 12 and 24 hours after surgery
Presence/Absence of vomiting
Time frame: At moment 0, 3, 6, 12 and 24 hours after surgery
Anesthesiological complications
Rate measurement
Time frame: Up to 1 weeks after surgery
Time to bowel movement
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Time to flatus
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Time to hunger
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Time to drink
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Time to eating
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Time to walking
Hours elapsed to event
Time frame: Up to 4 weeks after surgery
Postoperative complications
Rate measurement
Time frame: Up to 9 weeks after surgery
Compliance to ERAS protocol
Rate measurement
Time frame: Up to 4 weeks after surgery
Validated questionnaires
QoR15
Time frame: Administered 24 hours after surgery and up to 4 weeks after surgery
Ran from Jun 2017 to primary completion in Jul 2019, 25 months.
Of 55 non-industry interventional studies with no phase under Genital Diseases, Female, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's 25 months is above that.
Counting every sponsor, half of 65 studies reached it within 14 months; a quarter within 8 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia