An interventional study of Domestic single-port laparoscopic surgery system in Adenopathy, Uterine Fibroids and Ovarian Cysts, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Not applicable, Interventional, and Other
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.
77 studies on the registry are indexed under Lymphadenopathy; 14 are open to participants now.
This study's planned enrollment of 63 is below the median of 101 across 52 interventional studies indexed under Lymphadenopathy.
Browse Lymphadenopathy studies →Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 137 studies on the registry; 46 are open to participants now.
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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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: Domestic single-port laparoscopic surgery system
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。
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.
Time frame: Patient recruitment ends and all patients complete surgery, up to 2 years
Time of Operation
Time of operation includes total operation time, operator teleoperation time, robot system parking time and instrument docking time。
Time frame: From pre-surgery to the end of surgery，up to 12 hours
Blood Loss Evaluation
The estimated intraoperative blood loss and the difference of hemoglobin before and after operation.
Time frame: 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
Time frame: Up to 1 day after surgery
Time of First Postoperative Anal Exhaust
time recording
Time frame: Up to 2 day after surgery
First Spontaneous Urination Time
Time recording
Time frame: Up to 2 day after surgery
Pain Score
Visual Analogue Scale(VAS)
Time frame: 4 hours after surgery
Hospital Stays
Time
Time frame: From the date of admission to the Date of discharge, assessed up to 2 days
Postoperative Rehabilitation Evaluation
Quality of Life-15(QOL-15)
Time frame: Within 1 day after surgery; 24 hours and 30 days after discharge
Abdominal Incision Healing
Observation
Time frame: Within 1 day after surgery
Scar Satisfaction
Scar Cosmesis Assessment and Rating(SCAR)
Time frame: 30 days after discharge
Discharge Assessment
Postanesthesia Discharge Score(PADS)
Time frame: Within 1 day after surgery, 4 hours after discharge
Postoperative Complication
Telephone, Wechat official account and outpatient follow-up
Time frame: 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
Time frame: 30 days after discharge
Safety Evaluation
6 indexes of safety evaluations
Time frame: Day of surgery and within 1 day after surgery; 4 hours, 24 hours and 30 days after discharge
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Apr 2025; primary completion for Dec 2026, 20 months later.
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This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital of Wenzhou Medical University →