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In this study, a prospective study is used to select patients who will undergo intra-abdominal endoscopic single-port surgery system for benign gynecological diseases from February 2025 to December 2026 in the Second Affiliated Hospital of Wenzhou Medical University, including hysterectomy, myomectomy, ovarian cyst removal and adnexectomy. The study will perform statistical analysis to evaluate the feasibility and the main factors affecting the safety of intra-abdominal endoscopic single-port surgery system(SR-ENS-600) used in gynecological day surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Domestic single-port laparoscopic surgery system group | Other | The domestic single-port robotic laparoscopic surgery system is a new minimally invasive surgical method. Compared with traditional laparoscopic surgery, it establishes the surgical approach through the natural scar umbilicus of the human body, thus bringing less trauma and beautiful experience to patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Domestic single-port laparoscopic surgery system | Device | The minimum distance of the single-port surgical system from the port is 5-7cm to obtain the instrument bending space. The load capacity of surgical tools is increased from 2N to 5N, which greatly improves the structural reliability. At the same time, it can realize 6 degrees of freedom movement。 |
| Measure | Description | Time Frame |
|---|---|---|
| Day Surgery Success Rate | Day surgery success rate means that no other operation is performed during the operation and the patient is discharged within 48 hours. | Patient recruitment ends and all patients complete surgery, up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Operation | Time of operation includes total operation time, operator teleoperation time, robot system parking time and instrument docking time。 | From pre-surgery to the end of surgery,up to 12 hours |
| Blood Loss Evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingyu Yang, Master | Contact | +86 173 9805 4822 | yangxy_822@163.com | |
| Ping Duan, Master | Contact | +86 135 8743 0406 | dppddpp@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol | Feb 22, 2025 |
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|
The estimated intraoperative blood loss and the difference of hemoglobin before and after operation.
| From the time of hemoglobin measurement before surgery to the time of hemoglobin measurement after surgery, up to 1 day after surgery |
| Surgeon Satisfaction Evaluation | Surgeon satisfaction questionnaire | Up to 1 day after surgery |
| Time of First Postoperative Anal Exhaust | time recording | Up to 2 day after surgery |
| First Spontaneous Urination Time | Time recording | Up to 2 day after surgery |
| Pain Score | Visual Analogue Scale(VAS) | 4 hours after surgery |
| Hospital Stays | Time | From the date of admission to the Date of discharge, assessed up to 2 days |
| Postoperative Rehabilitation Evaluation | Quality of Life-15(QOL-15) | Within 1 day after surgery; 24 hours and 30 days after discharge |
| Abdominal Incision Healing | Observation | Within 1 day after surgery |
| Scar Satisfaction | Scar Cosmesis Assessment and Rating(SCAR) | 30 days after discharge |
| Discharge Assessment | Postanesthesia Discharge Score(PADS) | Within 1 day after surgery, 4 hours after discharge |
| Postoperative Complication | Telephone, Wechat official account and outpatient follow-up | 4 hours, 24 hours and 30 days after discharge |
| Quality and Safety Evaluation of Day Surgery | 13 indexes of quality and safety evaluation of day surgery | 30 days after discharge |
| Safety Evaluation | 6 indexes of safety evaluations | Day of surgery and within 1 day after surgery; 4 hours, 24 hours and 30 days after discharge |
| Mar 27, 2025 |
| Prot_SAP_002.pdf |
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form: Informed Consent Form | Feb 22, 2025 | Mar 27, 2025 | Prot_ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: New Technology and New Project Informed Consent Form | Apr 26, 2024 | Mar 27, 2025 | ICF_004.pdf |
| ID | Term |
|---|---|
| D000072281 | Lymphadenopathy |
| D007889 | Leiomyoma |
| D010048 | Ovarian Cysts |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003560 | Cysts |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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