A prospective randomized controlled study of single hole laparoscopic lateral abdominal wall suspension and single hole laparoscopic sacral fixation for the treatment of pelvic floor organ prolapse

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500096146

Enrollment

Unknown

Registered

2025-01-20

Start date

2024-09-03

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

pelvic organ prolapse

Interventions

Single hole laparoscopic lateral abdominal wall suspension surgery:N/A

Single hole laparoscopic sacral fixation:N/A

Eligibility

Sex/Gender

Female

Age

50 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with pelvic organ prolapse who came to the International Peace Maternity and Child Health Hospital for diagnosis and treatment from September 2024 to September 2025; 2. Patients who have given informed consent and signed the informed consent form; Adult females aged 30-75 years old; (1) Patients with at least one part of grade II-III or above, combined with other parts of grade II or above; (2) Patients who refuse conservative treatment or who have failed conservative treatment; 4. Patients who cooperate with follow-up for 1-2 years after surgery.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of pelvic radiotherapy; 2. Patients with a history of vaginal mesh treatment for prolapse; 3. Patients with immune diseases who have been using steroids for a long time; 4. Patients with pelvic pain syndrome (such as fibromyalgia and bladder pain syndrome) may experience increased sensitivity to pelvic pain; 5. Suspected patients with pelvic malignant tumors; 6. Patients with organic lesions of the lumbar and sacral vertebrae (such as lumbar disc herniation, ankylosing spondylitis) causing pain.

Design outcomes

Primary

Measure	Time frame
pelvic organ prolapse quantitive examination;Pelvic Floor Dysfunction Inventory (PFDI) -20;Pelvic Floor Dysfunction Impact Questionnaire (PFIQ) -7;Patient Reported Outcomes;Patient's overall improvement impression (PGI-I);Quality of Life;Magnetic resonance imaging;	—

Secondary

Measure	Time frame
Intraoperative bleeding;operative time;Retain catheterization time;hospital stay;	—

Countries

China

Contacts

Public ContactWang Jun

Shanghai Jiao Tong University School of Medicine Affiliated International Peace Maternity and Child Health Hospital

wangjun200408@aliyu.com+86 183 1706 7659

Outcome results

None listed

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