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Efficacy and safety of robotic single-port laparoscopy versus single-port laparoscopy for pelvic floor reconstruction in patients with pelvic organ prolapse: a prospective, multicenter cohort study

Efficacy and safety of robotic single-port laparoscopy versus single-port laparoscopy for pelvic floor reconstruction in patients with pelvic organ prolapse: a prospective, multicenter cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121836
Enrollment
Unknown
Registered
2026-04-03
Start date
2026-04-07
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Pelvic organ prolapse

Interventions

Robotic single-port laparoscopic group:None
Traditional single-port laparoscopic group:None

Sponsors

Shanghai First Maternity and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Age 18 to 70 years; 2) BMI 18.5 kg/m^2 to 30 kg/m^2; 3) Willing to undergo laparoscopic pelvic floor reconstruction under general anesthesia (presacral fixation, lateral abdominal wall suspension, iliopectine ligament suspension, high sacral ligament suspension); 4) Physically fit for laparoscopic surgery; 5) Willing to cooperate and complete study follow-up and related examinations; 6) American Society of Anesthesiologists (ASA) classification I to III; 7) Participant or their representative voluntarily participates in this trial and signs a written informed consent form.

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactating women. 2) Patients with stage IV malignant tumors. 3) Patients requiring emergency surgery. 4) Patients with active bleeding, coagulation disorders (prothrombin time (PT) or international normalized ratio (INR) = 1.5 times the upper limit of normal), or platelet count < 80 × 10^9/L. 5) Patients with severe cardiovascular or circulatory system diseases who cannot tolerate surgery. 6) Patients with a history of severe respiratory depression or severe bronchial asthma. 7) Patients with known or suspected gastrointestinal obstruction, including paralytic ileus. 8) Patients with sensory disturbances such as hyperalgesia or other physical pain that affects postoperative pain assessment. 9) Patients with severe hepatic impairment. 10) Subjects with comorbid mental illness or cognitive impairment. 11) Subjects who have participated in other clinical trials within the past month. 12) Subjects who cannot understand the trial requirements or complete the study follow-up plan. 13) The researchers believe there are other circumstances that make the student unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Perioperative complications;

Secondary

MeasureTime frame
Surgical success rate;Intraoperative blood loss;Postoperative hospital stay;Postoperative incision aesthetic evaluation;Postoperative pain score;Occurrence of adverse events;Patient satisfaction;Function recovery status;

Countries

Chine

Contacts

Public ContactGuizhu Wu

Shanghai First Maternity and Infant Hospital

wugz6666@tongji.edu.cn+86 189 3050 2615

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026