A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System to Assist Gynecological Day Surgery
Phase: NA
Conditions: Adenopathy, Uterine Fibroids, Ovarian Cysts, Adnexal Mass, Ovarian Diseases, Adnexal Cyst, Adnexal Diseases
Sponsor: Second Affiliated Hospital of Wenzhou Medical University

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Title：A Clinical Study on the Feasibility and Safety of Abdominal
Endoscopic Single-port Surgery System to Assist Gynecological Day
Surgery
NCT number：NCT06828419
Document date：February 22, 2025

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Study Protocol and Statistical Analysis Plan
1.
Research topics
A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery
System to Assist Gynecological Day Surgery
2.
Research purpose
Evaluate the feasibility and safety of using a domestically produced single-port
laparoscopic surgical system(SR-ENS-600) for gynecological day surgery, providing reference
for doctors and patients in the selection of surgical methods.
3.
Research background
For female ovarian cyst, ovarian endometriosis cyst, ovarian germ cell tumor, uterine
fibroids and precancerous lesions and other diseases, laparoscopic surgery is the main means
of treatment.Although gynecological day surgery with rapid admission has been gradually
carried out in medical institutions, in the latest recommended List of day surgery issued by the
National Health Commission (2022 edition), gynecological laparoscopic surgery only includes
laparoscopic resection of damaged ovaries, which cannot meet the diversified surgical needs of
women. Therefore, it is urgent to expand gynecological laparoscopic surgery under day
medical treatment.
With the development of science and technology and laparoscopic technology, robotic
single-port
laparoscopic
came into being.Through
a single incision,
it can achieve
approximately "traceless" surgical effect, reduce surgical trauma and shorten postoperative
recovery time, which is an important technical way to achieve day surgery. However, in the
face of international export restrictions on Da Vinci® SP single-port robots and not yet
approved in the field of gynecology, we urgently need to replace single-port robots with
domestic production, and even realize the corner overtaking of Chinese technology.
4.
Research contents
In this study, the feasibility evaluation is divided into main evaluation indicators (success
rate of daytime surgery) and secondary evaluation indicators (operation time, blood loss
evaluation, surgeon satisfaction questionnaire, first postoperative anal exhaust time, first
spontaneous urination time, pain score, length of hospital stay, postoperative rehabilitation
score, abdominal incision healing, scar satisfaction, etc.).The safety evaluation of 6 objectively
quantifiable safety evaluations and 13 quality safety evaluations of daytime surgery will be
selected. We will conduct a prospective, single-center, single-arm clinical study to collect
relevant information of patients who received intra-abdominal endoscopic single-port surgery

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system to assist gynecological day surgery, and evaluate the feasibility of intra-abdominal
endoscopic single-port surgery system for gynecological day surgery and the main factors
affecting surgical safety through statistical analysis.
5.
Research methods and technical routes
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. By
collecting patient baseline data (including age, BMI, underlying disease, surgery-related
disease, lesion size, number of lesions), effectiveness assessment (the main evaluation
indicator is the success rate of day surgery and secondary evaluation indicators included
operation time, blood loss evaluation, surgeon satisfaction questionnaire, first postoperative
anal exhaust time, first spontaneous urination time, pain score, hospital stay, postoperative
rehabilitation
score,
abdominal
incision
healing,
scar
satisfaction,
etc.),
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safety
evaluations(including intraoperative vital signs, intraoperative complication rate, incidence of
postoperative resurgery, incidence of postoperative complications, adverse events and serious
adverse events), 13 quality and safety evaluation indicators of day surgery(including the
proportion of tertiary and tertiary operations, preoperative evaluation rate of anesthesia,
delayed discharge rate, incidence of surgical complications, unplanned re-visit rate within 30
days after discharge, unplanned re-hospitalization rate within 30 days after discharge,
unplanned re-operation rate, surgical wound infection rate, surgical site error rate, bed fall rate,
fall rate, medication error rate, mortality rate).

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6.
The name and address of the sponsor, the site where the trial was conducted, and the
name, qualification, and address of the investigator
Sponsor: the Second Affiliated Hospital of Wenzhou Medical University (Yuying children's
Hospital of Wenzhou Medical University)
Address: 109 Xueyuan West Road, Lucheng District, Wenzhou, Zhejiang Province
Name of researcher: Duanping
Researcher qualifications: chief physician, Professor, doctoral supervisor
7.
Type of trial design, randomization grouping method and level of blinding
Prospective study, real world study, no randomization, no blindness.
8.
The inclusion criteria, exclusion criteria, the steps of selecting subjects, and the
method of assigning subjects

Inclusion criteria
1）Women aged 18 to 75 years old, with a body mass index (BMI) of no more than 32
kg/m2;
2）Conscious, no history of mental illness, accompanied by an adult during the
perioperative period;
3）Educate the subjects, who are willing to undergo day surgery, understand and accept
the surgical method and anesthesia method;
4）Subjects and families understand perioperative care and are willing and able to
complete post-discharge care;
5）Elective surgery, no serious complications affecting the operation and prognosis, aCCI
age adjusted comorbidity index 0 points;
6）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
1) Moderate and high-risk patients will be excluded based on ANGEL adhesion risk
scoring system;
2) Subjects with hemorrhagic rupture of ectopic pregnancy and unstable vital signs;
3) Genital tract infection or in the acute phase of systemic infection;

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4) Subjects on long-term anticoagulant therapy or with coagulation dysfunction;
5) Subjects have severe heart and lung disease, liver and kidney dysfunction, and cannot
tolerate anesthesia;
6) A history of abdominal or diaphragmatic hernia, abnormal umbilical cord development,
or umbilical surgery;
7) Not willing to undergo endoscopic surgery;
8) Participated in other drug and device clinical trials within 3 months before surgery.
Calculating the number of cases need to achieve the intended purpose of the trial
according to the statistical principle.
Select the step and assignment method：Appropriate patients are selected by including
exclusion criteria, and after full informed consent, patients and physicians jointly select definite
surgical methods.
9.
The number of cases required to achieve the intended purpose of the trial
Estimation of sample size：In this study, the number of trial cases is inferred based on the
method of calculating the sample size of a single group of target values, and the success rate of
daytime surgery is the main outcome index. Based on the joint research and discussion of
clinical trial institutions, principal investigators and statistical analysts.
According to the formula：
In the formula, n is the sample size, Z1-α/2 and Z1-β are the quantiles of standard
normal distribution, PT is the expected surgical success rate, and P0 is the target value.
According to clinical experience and relevant references, the target value of this study P0
is 90% and the expected success rate of day surgery PT is 99% .The number of subjects is at
least 56 with a confidence of 80% (1-β) and a test level of 0.025 (unilateral). Considering that
the shedding rate of subjects during the trial is about 10%, 63 cases are planned to be enrolled
in this study.
10. Study risks and risk disposal plans
1) If adverse events or serious adverse events occur in patients, the treatment plan is
detailed below.
2) Patients are lost to follow-up due to various reasons and the preset scheme is analyzed
according to the actual surgical methods of patients.

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3) Possible intraoperative risks: heavier adhesion, more bleeding, or laparotomy; carbon
dioxide emia, air embolism, subcutaneous, retroperitoneal emphysema, hematoma; other
unpredictable accidents and complications may occur. Preset plan, the corresponding medical
treatment is provided by the doctor of the diagnosis and treatment team, and the transfer to
open surgery is not included in the data analysis.
4) Postoperative risk: intestinal adhesion, intestinal obstruction, venous thrombosis of
lower extremity, pulmonary embolism; postoperative bleeding requires a second operation;
incision dehiscence, incision infection, incisional hernia; shoulder pain; unpredictable
accidents and complications may occur. Preset plan, regular postoperative outpatient follow-up,
pay attention to patients' incision and other related prognosis outcomes. If there are
postoperative complications, the doctor of the diagnosis and treatment team will provide
corresponding medical treatment.
11. Criteria for discontinuing clinical trials and provisions for ending clinical trials
Criteria for patient termination of clinical trials: 1) Patients from admission to observation
1 month after surgery; 2）Patients lost to follow-up due to death, accidents and other reasons; 3）
Patients occur serious adverse events; 4) Patients requested that the trial be terminated.
End of clinical trial：The prospective cohort is currently starting to count up to 63 patients,
with the last person reaching the observational endpoint or discontinuing the trial for other
reasons.
12. Recording requirements for adverse events and reporting methods, treatment
measures, follow-up methods, time and outcome of serious adverse events
Definition of serious adverse event (SAE): refers to the death, life-threatening, permanent
or serious disability or loss of function of the subject after receiving the investigational drug, as
well as congenital anomalies or birth defects and other adverse medical events.In the event of a
serious adverse event, investigators should report it to our Medical Ethics Committee within 24
hours of learning about it.
Treatment measures: subjects with SAE will receive clinical treatment in time and be
followed up until their condition improve or they die.
13. Statistical analysis method
Single group target value test, description analysis, Pearson correlation coefficient
description, Spearman rank correlation coefficient test, etc.
14. Provisions on data management and data traceability
This research group is responsible for the data management of this study to ensure the
authenticity, integrity, privacy and traceability. The project leader or other authorized

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researchers fill in the information in the CRF form, and only researchers with medical
qualifications can fill in the original clinical evaluation / safety data. After the original data is
entered, any modifications made by the project leader or other authorized researchers on the
CRF form will be recorded. Any modification of approved data will make the name of the
modified researcher or other authorized researcher, the date of modification and the reason for
modification (if the change is not significant).
15. Quality control of test
Researchers will adopt standard operating procedures to ensure the quality control of
clinical trials and the implementation of quality assurance system. All observations and
findings in the clinical trial will be verified to ensure the reliability of the data and ensure that
all conclusions in the clinical trial are derived from the original data. Quality control is adopted
at each stage of data processing to ensure that all data are reliable and processed correctly.
16. Ethical requirements;
1) Before the clinical trial, the trial plan needs to be reviewed by the ethics committee.
The review result is consent, and the approval document can be signed before implementation.
2) During the trial, the WMA declaration of Helsinki (2013), CIOMS International
Ethical Guidelines for human biomedical Research (2016) and National Health and Family
Planning Commission of the ethical review for biomedical research involving humans beings
(2016) will be followed.
3) During the trial, any modification of the clinical research protocol, informed consent,
recruitment materials, etc. must be reviewed and approved by the ethics committee before
implementation.
4) Before each subject is selected for this study, the researcher must introduce to the
subject in detail the purpose of this study, the test process and duration, the inspection operation,
the expected possible benefits and risks of the subject, the money and time that may be spent.
In addition, the researcher needs to inform the subjects that participating in this trial is entirely
voluntary, and has the right to withdraw from the trial at any stage of the trial without
discrimination and retaliation, and their medical treatment and rights will not be affected.
5) After the investigator has fully and in detail explained the situation of the test, the
subject or his legal representative (for the incapacitated subject) should sign and date the
informed consent form. The investigator performing the informed consent process should also
sign the name and date on the informed consent form. The informed consent form is in
duplicate, which should be kept by the subject and the investigator respectively.
17. Expected progress and completion date of clinical research

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Time
Expected progress
2025.03.01～2026.3.31
Recruit patients,complete the operation and complete
postoperative follow-up
2025.04.01～2025.06.30
Collect and analyze data
2026.07.01～2026.12.31
Complete project summary, appraisal, results
declaration, etc
18. Follow up and medical measures after the end of the study
None.
19. Responsibilities of each party and other relevant provisions
In case of any damage related to this experimental study, the project research team will
compensate according to relevant national laws and regulations.
20. References
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