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A Randomized Controlled Study Comparing the Efficacy and Safety of Autologous Tissue Repair Versus STARR Procedure for internal rectal prolapse

A Randomized Controlled Trial on the Efficacy and Safety of Integral Three-Level Autologous Fascia Repair Guided by the Integral Theory of Pelvic Floor Versus STARR Procedure for internal rectal prolapse

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121830
Enrollment
Unknown
Registered
2026-04-03
Start date
2026-05-01
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

Internal Rectal Prolapse

Interventions

Integral Autologous Fascia Repair Group:The integral three-level autologous fascia repair guided by the Integral Theory of Pelvic Floor procedure was performed.
STARR Procedure Group:The STARR procedure was performed.

Sponsors

Luoyang Central Hospital Affiliated to Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients must meet all of the following criteria to be enrolled: 1. Aged 18 to 75 years (inclusive). 2. Oxford grade III or IV rectal intussusception; or prolapse depth >31 mm; or multiple sites of intussusception; or intussusception thickness >5 mm. 3. Presence of obstructed defecation syndrome symptoms, with a Longo's ODS score >=11. 4. Voluntarily participate in the study and provide written informed consent. 5. Willing and able to complete all follow-up visits as required by the study protocol.

Exclusion criteria

Exclusion criteria: Patients will be excluded if they meet any of the following criteria: 1. Presence of severe psychological disorders, with a Hospital Anxiety and Depression Scale (HADS) score of =11 on either the Anxiety (HADS-A) or Depression (HADS-D) subscale. 2. Coexisting colorectal tumors, inflammatory bowel disease, or other severe pelvic conditions requiring surgical intervention. 3. Diagnosis of slow-transit constipation confirmed by colonic transit test. 4. Presence of endocrine disorders such as hypothyroidism or diabetes mellitus. 5. Severe cardiac, pulmonary, hepatic, or renal dysfunction (ASA physical status classification = Grade IV). 6. History of major abdominal, pelvic, or perianal surgery (except for procedures such as appendectomy or cholecystectomy that do not interfere with the surgical procedures in this study). 7. Pregnancy or lactation. 8. Diagnosis of spastic pelvic floor constipation (including conditions such as puborectalis hypertrophy and spastic pelvic floor syndrome).

Design outcomes

Primary

MeasureTime frame
Depth of Rectal Intussusception;Obstructed Defecation Syndrome (ODS) Score;Complication Rate;Recurrence rate;

Secondary

MeasureTime frame
Operation time;Intraoperative Blood Loss;Time to First Flatus/Defecation;Postoperative Pain Score;Length of Hospital Stay;Fecal Incontinence Wexner Score;Gastrointestinal Quality of Life Index (GIQLI);Patient Assessment of Constipation Quality of Life (PAC-QOL) Questionnaire;

Countries

China

Contacts

Public ContactMei Zhibiao

Luoyang Central Hospital Affiliated to Zhengzhou University

354947202@yeah.net+86 186 3791 4007

Outcome results

None listed

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