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

Version number：V1.0
Edition date：2025.2.22
AF/SQ-33-2.1
1
Version number：V1.0
Edition date：2025.2.22
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

Version number：V1.0
Edition date：2025.2.22
AF/SQ-33-2.1
Version number：V1.0
Edition date：2025.2.22
Informed Consent Form • Notice Page
Dear madam
We will invite you to participate in a clinical trial study of “a clinical study on the feasibility
and safety of abdominal endoscopic single-port surgery system to assist gynecological day
surgery”.
Before you decide whether to participate in this study, please read the following content as
carefully as possible. It can help you understand the content of this study, why to conduct this
study, and the benefits, risks and discomfort this study may bring to you.The research plan has
been reviewed by the medical ethics committee of the Second Affiliated Hospital of Wenzhou
Medical University and the Yuying children's Hospital of Wenzhou Medical University. It
complies with the relevant laws and regulations of China and the declaration of Helsinki and other
ethical principles to protect the rights and interests of subjects.
Research Introduction
1. Research Background
Robotic single-port laparoscopy is a new minimally invasive surgery method. Compared with
traditional laparoscopy, it has 3D visual effect, flexible micro-joint, eliminating tremor of the hand
and other technical advantages, which provides a good guarantee for the clinical development of
more delicate, complex and accurate surgery.At the same time, the approximate "traceless"
surgical effect is achieved, and technical limitations such as long learning curve, instrument
congestion and "chopstick effect" are overcome. Although this minimally invasive approach has
been shown to be applicable to gynecological benign and malignant surgery, there is no clear
conclusion to prove whether robotic single-port laparoscopy is feasible and safe for gynecological
day surgery.In this study, 63 patients in the Second Affiliated Hospital of Wenzhou Medical
University who chose to undergo abdominal endoscopic single-port surgery system for benign
gynecological diseases will be collected to analyze the feasibility and safety of abdominal
endoscopic single-port surgery system to assist gynecological day surgery.
2. Research Objective
To evaluate the feasibility and safety of using a domestically produced single-port
laparoscopic surgical system(SR-ENS-600) for gynecological day surgery, and to provide
reference for doctors and patients in the choice of surgical methods.
3. What will I need to do if I take part in the research?

Version number：V1.0
Edition date：2025.2.22
AF/SQ-33-2.1
Version number：V1.0
Edition date：2025.2.22
1. Your basic information, including age, BMI, and underlying diseases, will be collected.
Information related to this operation, including surgery-related diseases, lesion size, lesion
number, operation time, intraoperative blood loss, and postoperative pain, will be collected;
2. On discharge day, you will be required to cooperate with the researcher to complete vital
signs monitoring, gynecological examination, laboratory examination, assessment of anal
exhaust time, autonomous urination time, complete 6 safety evaluations, discharge score after
anesthesia, and postoperative rehabilitation evaluation;
3. You will be expected to cooperate with the anesthesiologist to complete the postoperative
follow-up
by
phone
within
4
hours
after
discharge,
including
post-discharge
consciousness/mental state, dizziness, sore throat, nausea/vomiting, hoarseness, limb muscle
strength, pain, whether you stay overnight, drug use, etc., as well as post-discharge discharge
score and safety evaluation;
4. You will be expected to cooperate with the nurse to complete the postoperative follow-up
by telephone within 24 hours after discharge, including postoperative complications, drug
combination, safety evaluation and postoperative rehabilitation evaluation;
5. You will be expected to complete the postoperative follow-up in the outpatient department
of our hospital 30 days after discharge, which includes vital signs monitoring, gynecological
examination, laboratory and imaging examination, postoperative complications, drug
combination, safety evaluation, postoperative rehabilitation evaluation, quality and safety
evaluation of 13 daytime operations, and scar satisfaction evaluation;
6. Your data will be accessed by researchers, but we will ensure that your privacy is not
violated.
4. What are the inclusion and exclusion conditions?

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

Version number：V1.0
Edition date：2025.2.22
AF/SQ-33-2.1
Version number：V1.0
Edition date：2025.2.22
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;
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.
5. If you participate in this study, what benefits will you get?
You may get a more accurate diagnosis by participating in this study, and you may not
benefit directly. The information gained from this study may be helpful to others in the
future.
6. What are the risks for me to participate in the research?
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. Postoperative risk: intestinal adhesion,
intestinal obstruction, venous thrombosis of lower extremity, pulmonary embolism;

Version number：V1.0
Edition date：2025.2.22
AF/SQ-33-2.1
Version number：V1.0
Edition date：2025.2.22
Postoperative bleeding requires a second operation; Incision dehiscence, incision infection,
incisional hernia; Shoulder pain; Unpredictable accidents and complications may occur.
7. Will participating in this study increase my medical expenses?
In this study, preoperative and postoperative examination and detection are required for
normal clinical diagnosis and treatment, and the cost shall be borne by the subjects. The cost
of the surgical robot involved in this study shall be borne by the company, and no additional
cost of other tests shall be involved in this study, so this study will not increase your financial
burden.
8. What will be the compensation for participating in this study?
If you participate in this study, you will receive 1000 yuan of transportation subsidy and
nutrition subsidy, which will be paid after the visit is completed.
9. Damages
The sponsor has purchased clinical trial liability insurance for this study. If you suffer
any injury related to this study, our research group will compensate you in accordance with
relevant national laws and regulations.
10. Is personal information confidential?
If you decide to participate in this study, your personal information and related materials
during the trial and your participation in the trial are confidential.All test results (including
personal data, test documents, etc.) appearing in the original medical records will be
completely confidential within the scope of the law, and only your initials and numbers
assigned when you participate in the test will appear. If necessary, only your initials and
numbers will appear in relevant research summaries, articles, and public publications.
When necessary, the drug regulatory department, the ethics committee or the project
funding department can consult the data of the subjects participating in the study according to
the regulations. However, without permission, they will not use the information of the
subjects participating in the study for other purposes or disclose it to other groups.
11. How can I get more information?
You can ask any question about this experimental study at any time. You can consult Dr.
Yang Xingyu at 17398054822. (mobile number).
If there is any important new information during the trial that may affect your

Version number：V1.0
Edition date：2025.2.22
AF/SQ-33-2.1
Version number：V1.0
Edition date：2025.2.22
willingness to continue participating in the study, your doctor will notify you in time.
12. Do I have to take part in this research or can I quit halfway?
It is entirely up to you to participate in this study. You may refuse to participate in this
study. You have the right to withdraw from the study at any time during the study. If you
refuse participate in or withdraw, your benefits will not be affected, nor will you be
discriminated against or retaliated for it. If you choose to participate in this study, we hope
you can insist on completing the whole trial process.
Your doctor or researcher may suspend your participation in this trial at any time for the
best interests of you.
13. Is there any other treatment currently available?
If you do not participate in this study, you may choose other treatment options. Please
consult the investigator or your doctor for specific treatment options.
14. What should we do now?
Whether to participate in this pilot study is up to you. You can discuss with your family
or friends before making a decision.
Before you make the decision to participate in the trial, please ask your doctor for
relevant questions as far as possible until you fully understand the trial.
15. Ethics committee
If you have any dissatisfaction in the study, please contact the medical ethics committee
of the Yuying children's Hospital Affiliated to Wenzhou Medical University, the Second
Affiliated Hospital of Wenzhou Medical University.
Ethics Committee Office: Longwan District Ethics Committee Office of Yuying
children's Hospital Affiliated to Wenzhou Medical University, the Second Affiliated Hospital
of Wenzhou Medical University.
Contact: Teacher Chen Tel.: 0577-85676879
Thank you for reading the above materials. If you decide to participate in this
experimental study, please tell your doctor, and he / she will arrange all matters related to the
experiment for you.
Please keep this information.

Version number：V1.0
Edition date：2025.2.22
AF/SQ-33-2.1
Version number：V1.0
Edition date：2025.2.22
Informed Consent Form • Consent Signature Page
Declaration of consent
1. I have read this informed consent form, and the relevant person in charge of the project has
explained the purpose, content, risks and benefits of this test to me in detail.
2. I have discussed and asked relevant questions about this study, and the answers to these
questions are satisfactory to me.
3. I have enough time to make a decision.
4. I voluntarily agree to participate in the clinical research described in this article.
5. If I withdraw due to the reason of this product, I will inform the doctor of the change of my
condition in time.
6. If I need to take any other treatment due to the change of my condition, I will consult the
doctor in advance or tell the doctor truthfully afterwards.
7. I agree with the representatives of the drug regulatory department, the ethics committee or the
project funding department to consult my research materials.
8. I will obtain a signed and dated copy of the informed consent form.
Finally, I decided to agree to participate in this pilot study and promised to follow the doctor's
advice.
Signature of the subject:
Date:
Contact number of the subject:
Signature of legal representative:
Date:
Relationship with the subject:
legal representative Tel.:
＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿＿
I confirm that I have explained the details of this study to the subject, including his rights and
possible benefits and risks, and gave him a copy of the signed informed consent.
Signature of doctor:
Date:
Contact information of study doctor:
(This page is a necessary part of the subject's informed consent. Each “subject's informed consent”
must be signed and dated by the subject or legal representative and the research doctor before it is
valid.)