- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07642791
Safety of Opportunistic Salpingectomy During Elective Laparoscopic Cholecystectomy.
Safety of Opportunistic Salpingectomy During Elective Laparoscopic Cholecystectomy: A Randomized Controlled Trial
The knowledge, coupled with epidemiological studies demonstrating lower ovarian cancer rates in women with a history of tubal sterilization has led to recommendations for opportunistic salpingectomy at the time of benign gynecological surgery. However, this recommendation was not explored in the setting of non-gynecological surgeries, of most if the surgery performed not in pelvis.
This study aims to evaluate the safety of performing opportunistic salpingectomy at the time of elective laparoscopic cholecystectomy in women aged 45 years or older. Of note, the only available prospective study from Austria evaluated feasibility of combined operation. By assessing complication rates and other perioperative outcomes, the study seeks to determine if this combined approach is a safe for opportunistic ovarian cancer prevention. Ultimately, this research may inform surgical practice and potentially reduce the incidence of ovarian cancer in this population.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Zurich, Schweiz, 8091
- Division of Visceral Surgery and Transplantation , University Hospital Zurich
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Women aged 45 years or older.
- No known history of ovarian or fallopian tube cancer.
- Completed family planning.
- Scheduled to undergo elective laparoscopic cholecystectomy for benign gallbladder disease.
- Able to provide informed consent.
- Willing to comply with study procedures and follow-up assessments.
Exclusion Criteria:
- Previous abdominal Surgery or any inflammatory bowel disease.
- Current pregnancy or breastfeeding (verbally asked).
- Contraindications to laparoscopic surgery (e.g., severe cardiopulmonary disease, extensive prior abdominal surgery).
- Any medical condition that, in the opinion of the investigator, would preclude safe participation in the study or interfere with follow-up.
- Participation in another clinical trial that may confound the results of this study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Experimental group
Opportunistic salpingectomy during surgery.
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Opportunistic salpingectomy at the time of elective laparoscopic cholecystectomy will be performed in study group, while the control group undergo cholecystectomy without salpingectomy.
Cholezystectomy as controll group
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Aktiv komparator: Control group
Elective cholecystectomy
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Cholezystectomy as controll group
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postoperative complications assesed with Comprehensive complication index.
Tidsram: within 6 weeks after surgery
|
This will be the primary outcome measure, encompassing any complications assessed with Comprehensive Complication Index.
The range between 0 and 100.
The higher score means more complications.
|
within 6 weeks after surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Operating time
Tidsram: Operating time in minutes during surgical procedure
|
Operating time measured in minutes from incision until skin stich
|
Operating time in minutes during surgical procedure
|
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Length of hospital stay
Tidsram: Length of hospital stay: The number of days patients remain hospitalized after surgery untill discharge assedd at discharge (assessed at around 5 days).
|
Length of hospital stay calculated in days
|
Length of hospital stay: The number of days patients remain hospitalized after surgery untill discharge assedd at discharge (assessed at around 5 days).
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Dilmurodjon MDE Eshmuminov, MD, Univercity hospital zurich
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Sjukdomar i det endokrina systemet
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Matsmältningssystemets sjukdomar
- Genitala sjukdomar, kvinnor
- Neoplasmer i endokrina körtel
- Gallvägssjukdomar
- Ovariella sjukdomar
- Adnexala sjukdomar
- Genitala neoplasmer, hona
- Gonadal sjukdomar
- Gallblåsan sjukdomar
- Kolelithiasis
- Ovariella neoplasmer
- Kolecystolitiasis
- Kirurgiska ingrepp, operativ
- Matsmältningssystemets kirurgiska procedurer
- Gallvägs kirurgiska procedurer
- Kolecystektomi
Andra studie-ID-nummer
- 2026-00157
Plan för individuella deltagardata (IPD)
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