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NCT Number: NCT06828419

A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System to Assist Gynecological Day Surgery

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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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18 to 75 years old, with a body mass index (BMI) of no more than 32 kg/m2;
  • Conscious, no history of mental illness, accompanied by an adult during the perioperative period;
  • Educate the subjects, who are willing to undergo day surgery, understand and accept the surgical method and anesthesia method;
  • Subjects and families understand perioperative care and are willing and able to complete post-discharge care;
  • Elective surgery, no serious complications affecting the operation and prognosis, aCCI age adjusted comorbidity index 0 points;
  • According to the adhesion risk scoring system of European Anti-Adhesions in Gynaecology Expert Panel (ANGEL), the adhesion risk was divided into three levels: high, medium and low. Subjects with low risk (0 to 12 points) and abdominal wall scarring and pelvic cavity B-ultrasonography do not indicate obvious pelvic cavity adhesion wiil be included.

Exclusion criteria

  • Moderate and high-risk patients will be excluded based on ANGEL adhesion risk scoring system;
  • Subjects with hemorrhagic rupture of ectopic pregnancy and unstable vital signs;
  • Genital tract infection or in the acute phase of systemic infection;
  • Subjects on long-term anticoagulant therapy or with coagulation dysfunction;
  • Subjects have severe heart and lung disease, liver and kidney dysfunction, and cannot tolerate anesthesia;
  • A history of abdominal or diaphragmatic hernia, abnormal umbilical cord development, or umbilical surgery;
  • Not willing to undergo endoscopic surgery;
  • Participated in other drug and device clinical trials within 3 months before surgery.

Treatment and study plan

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。

Primary outcomes

  1. Day Surgery Success Rate

    Time frame: Patient recruitment ends and all patients complete surgery, up to 2 years

    Day surgery success rate means that no other operation is performed during the operation and the patient is discharged within 48 hours.

Secondary outcomes

  1. Time of Operation

    Time frame: From pre-surgery to the end of surgery,up to 12 hours

    Time of operation includes total operation time, operator teleoperation time, robot system parking time and instrument docking time。

  2. Blood Loss Evaluation

    Time frame: From the time of hemoglobin measurement before surgery to the time of hemoglobin measurement after surgery, up to 1 day after surgery

    The estimated intraoperative blood loss and the difference of hemoglobin before and after operation.

  3. Surgeon Satisfaction Evaluation

    Time frame: Up to 1 day after surgery

    Surgeon satisfaction questionnaire

  4. Time of First Postoperative Anal Exhaust

    Time frame: Up to 2 day after surgery

    time recording

  5. First Spontaneous Urination Time

    Time frame: Up to 2 day after surgery

    Time recording

  6. Pain Score

    Time frame: 4 hours after surgery

    Visual Analogue Scale(VAS)

  7. Hospital Stays

    Time frame: From the date of admission to the Date of discharge, assessed up to 2 days

    Time

  8. Postoperative Rehabilitation Evaluation

    Time frame: Within 1 day after surgery; 24 hours and 30 days after discharge

    Quality of Life-15(QOL-15)

  9. Abdominal Incision Healing

    Time frame: Within 1 day after surgery

    Observation

  10. Scar Satisfaction

    Time frame: 30 days after discharge

    Scar Cosmesis Assessment and Rating(SCAR)

  11. Discharge Assessment

    Time frame: Within 1 day after surgery, 4 hours after discharge

    Postanesthesia Discharge Score(PADS)

  12. Postoperative Complication

    Time frame: 4 hours, 24 hours and 30 days after discharge

    Telephone, Wechat official account and outpatient follow-up

  13. Quality and Safety Evaluation of Day Surgery

    Time frame: 30 days after discharge

    13 indexes of quality and safety evaluation of day surgery

  14. Safety Evaluation

    Time frame: Day of surgery and within 1 day after surgery; 4 hours, 24 hours and 30 days after discharge

    6 indexes of safety evaluations

Study contacts

Contact information is provided by the study sponsor or research team.

Ping Duan, Master

CONTACT

[email protected]

+86 135 8743 0406

Xingyu Yang, Master

CONTACT

[email protected]

+86 173 9805 4822

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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