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Comparison of Transumbilical Single-Port Laparoscopy and Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) for Ovarian Cystectomy: A Prospective, Multicenter, Randomized Controlled Trial

Comparison of Transumbilical Single-Port Laparoscopy and Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) for Ovarian Cystectomy: A Prospective, Multicenter, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120929
Enrollment
Unknown
Registered
2026-03-23
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Ovarian Cyst

Interventions

Experimental Group:Transumbilical Laparoendoscopic Single-Site Ovarian Cystectomy
Control Group:Transvaginal Natural Orifice Transluminal Endoscopic Ovarian Cystectomy

Sponsors

Obstetrics & Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Women of reproductive age, aged 18 to 50 years. 2. Diagnosis of benign ovarian cystic lesions indicated by preoperative imaging (transvaginal ultrasonography, or MRI if necessary), scheduled for ovarian cystectomy. 3. Maximum diameter of the cyst between 4 and 10 cm. 4. No high suspicion of malignancy based on preoperative serum tumor markers (e.g., CA125, CA19-9, AFP, CEA). 5. General condition suitable for laparoscopic surgery, with an American Society of Anesthesiologists (ASA) physical status classification of I or II. 6. Willingness to participate in the study, provide written informed consent, and comply with the follow-up schedule.

Exclusion criteria

Exclusion criteria: 1. Preoperative suspicion or confirmation of ovarian malignancy or borderline tumor, or high suspicion of ovarian endometrioma (chocolate cyst). 2. Vaginal stenosis, acute vaginitis, or obliteration of the pouch of Douglas (cul-de-sac) due to severe pelvic adhesions. 3. History of abdominal surgery (particularly major umbilical or pelvic procedures) likely to cause severe adhesions; or history of incisional hernia. 4. Pregnancy or lactation. 5. Severe medical or surgical comorbidities (e.g., cardiac, pulmonary, hepatic, or renal dysfunction; coagulation disorders) that contraindicate surgery or anesthesia. 6. Cognitive, communication, or psychiatric disorders that prevent effective communication or compliance with questionnaires and follow-up.

Design outcomes

Primary

MeasureTime frame
Operative Time;

Secondary

MeasureTime frame
Estimated Blood Loss (EBL);Cyst Rupture Rate;Conversion Rate;Postoperative VAS Score;Postoperative Analgesic Consumption;Time to First Flatus;Time to First Ambulation;Postoperative Length of Stay;Complications;Ovarian Function Indicators (Serum AMH, Ultrasound AFC);Body Image Scale;SF-12/FSFI;SAS/SDS;Cosmetic Satisfaction Score;Total Hospitalization Cost;Instrument Cost;Recurrence Rate;

Countries

China

Contacts

Public ContactXiaojuan Wang

Obstetrics & Gynecology Hospital of Fudan University

wxj021021@126.com+86 138 1792 1708

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 4, 2026