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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorSecond Affiliated Hospital of Wenzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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。

Treatment groups

63 Participants
are divided into 1 treatment group
Group A: Domestic single-port laparoscopic surgery system groupOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

Surgeon Satisfaction Evaluation

Surgeon satisfaction questionnaire

Time frame
Up to 1 day after surgery
4

Time of First Postoperative Anal Exhaust

time recording

Time frame
Up to 2 day after surgery

Other outcomes

Sponsors and contacts

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