Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION)
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- STATUS
- Recruiting
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- End date
- Dec 31, 2028
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- participants needed
- 124
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- sponsor
- Seoul National University Hospital
Summary
The SOLUTION trial aims to show the efficacy and safety of performing
Description
- Carbon
dioxide is supplied duringlaparoscopic operations to maintain capnoperitoneum, which can cause the implantation and proliferation oftumor cells exposed to the peritonealcavity . - Insertions of uterine manipulators into the endometrial
cavity is commonly done, which can causetumor cells to travel to both salpinges. Tumor cells can be exposed to the peritonealcavity when the cervix is exposed during intracorporeal colpotomy.Tumor cells exposed to the peritonealcavity can travel upwards when the patient's position is maintained in theTrendelenburg position during minimally invasive operations, leading to distantmetastasis .
Based on the above-mentioned hypothesis, the following methods could be applied to minimize
the exposure of
- The application of a vaginal tube instead of a uterine manipulator to prevent
tumor cells from traveling to the salpinges. - The ligation of both salpinges prior to insertion of a vaginal tube to block the travel
of
tumor cells . - The performance of extracorporeal colpotomy instead to prevent the exposure of
tumor cells inside the peritonealcavity .
Although it would be favorable to perform all the forementioned methods, extracorporeal
colpotomy is difficult to perform especially in menopausal patients with
In conclusion, this clinical trial aims to show the efficacy and safety of performing radical
Details
| Condition |
|
|---|---|
| Age | 20years - 100years |
| Treatment |
|
| Clinical Study Identifier | NCT04370496 |
| Sponsor | Seoul National University Hospital |
| Last Modified on | 19 February 2024 |
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