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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Opportunistic salpingectomy during surgery. |
|
| Control group | Active Comparator | Elective cholecystectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opportunistic salpingectomy | Procedure | Opportunistic salpingectomy at the time of elective laparoscopic cholecystectomy will be performed in study group, while the control group undergo cholecystectomy without salpingectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications assesed with Comprehensive complication index. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operating time | Operating time measured in minutes from incision until skin stich | Operating time in minutes during surgical procedure |
| Length of hospital stay | Length of hospital stay calculated in days |
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Inclusion Criteria:
Exclusion Criteria:
. "sex and gender" dimensions are not relevant in this study including only female gender.
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| Name | Affiliation | Role |
|---|---|---|
| Dilmurodjon MDE Eshmuminov, MD | Univercity hospital zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Visceral Surgery and Transplantation , University Hospital Zurich | Zurich | 8091 | Switzerland |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D041761 | Cholecystolithiasis |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| ID | Term |
|---|---|
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Randomized Controlled Trial
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| Cholecystectomy | Procedure | Cholezystectomy as controll group |
|
| Length of hospital stay: The number of days patients remain hospitalized after surgery untill discharge assedd at discharge (assessed at around 5 days). |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |