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Not yet recruiting NCT06828419

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

No phase Interventional Adenopathy Uterine Fibroids Ovarian Cysts Adnexal Mass

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Domestic single-port laparoscopic surgery system.
Who it may be relevant to
Registry conditions: Adenopathy, Uterine Fibroids, Ovarian Cysts, Adnexal Mass. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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。

Primary outcome measures

  • Day Surgery Success Rate [Time frame: Patient recruitment ends and all patients complete surgery, up to 2 years]
Secondary outcome measures (12)
  • Time of Operation [Time frame: From pre-surgery to the end of surgery，up to 12 hours]
  • 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]
  • Surgeon Satisfaction Evaluation [Time frame: Up to 1 day after surgery]
  • Time of First Postoperative Anal Exhaust [Time frame: Up to 2 day after surgery]
  • First Spontaneous Urination Time [Time frame: Up to 2 day after surgery]
  • Pain Score [Time frame: 4 hours after surgery]
  • Hospital Stays [Time frame: From the date of admission to the Date of discharge, assessed up to 2 days]
  • Postoperative Rehabilitation Evaluation [Time frame: Within 1 day after surgery; 24 hours and 30 days after discharge]
  • Abdominal Incision Healing [Time frame: Within 1 day after surgery]
  • Scar Satisfaction [Time frame: 30 days after discharge]
  • Discharge Assessment [Time frame: Within 1 day after surgery, 4 hours after discharge]
  • Postoperative Complication [Time frame: 4 hours, 24 hours and 30 days after discharge]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

China · 1 center
  • Second Affiliated Hospital of Wenzhou Medical University — Wenzhou

Identifiers

NCT: NCT06828419 · SAHoWMU-CR2024-07-124

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗