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

NCT06828419 | Not Yet Recruiting

• 1 other identifier: SAHoWMU-CR2024-07-124
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adenopathy; Uterine Fibroids; Ovarian Cysts; Adnexal Mass; Ovarian Diseases; Adnexal Cyst; Adnexal Diseases

Keywords

robotic-assisted laparoscopic single-site surgery (R-LESS); single-port robot system (SPRS); day surgery

Outcome Measures

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.

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

Secondary Outcomes (14)

• Time of Operation

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

• Blood Loss Evaluation

  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

  Up to 1 day after surgery

• Time of First Postoperative Anal Exhaust

  Up to 2 day after surgery

• First Spontaneous Urination Time

  Up to 2 day after surgery

Study Arms (1)

Domestic single-port laparoscopic surgery system group

OTHER

The domestic single-port robotic laparoscopic surgery system is a new minimally invasive surgical method. Compared with traditional laparoscopic surgery, it establishes the surgical approach through the natural scar umbilicus of the human body, thus bringing less trauma and beautiful experience to patients

Device: Domestic single-port laparoscopic surgery system

Interventions

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。

Domestic single-port laparoscopic surgery system group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Lymphadenopathy; Leiomyoma; Ovarian Cysts; Ovarian Diseases; Adnexal Diseases

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Cysts; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Xingyu Yang, Master

CONTACT

+86 173 9805 4822; yangxy_822@163.com

Ping Duan, Master

CONTACT

+86 135 8743 0406; dppddpp@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 14, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)