Refractory constipation
Conditions
Interventions
Treatment group:Sacral nerve modulation
Control group:Sacral nerve modulation
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the study and sign the informed consent. 2. Patients aged 18-70 (inclusive) at the time of signing the informed consent. 3. Patients diagnosed with FC according to Rome IV criteria. FC diagnostic criteria: (1) It must include 2 or more of the following: 1) More than 1/4 (25%) have difficulty defecating; 2) More than 1/4 (25%) of defecation was dry or hard feces (Bristol fecal Traits Scale Type 1-2); 3) More than 1/4 (25%) of the defecation feeling inadequate; 4) Anal rectum obstruction/blockage in more than 1/4 (25%) of defecation; 5) More than 1/4 (25%) of defecation needs manual assistance (such as finger assistance for defecation, pelvic floor support); 6) Less than 3 SBMS per week; (2) Loose stools rarely occur without purgative; (3) Do not meet the diagnostic criteria for irritable bowel syndrome (IBS); (4) Symptoms appeared at least 6 months before diagnosis, and above diagnostic criteria were met in the last 3 months. 4. Patients had less than 3 SBMS per week in the 2 weeks before screening visit. 5. No clinically significant findings were found in colonoscopy completed within 5 years prior to screening or at screening visit. 6. The patient has not responded well to conventional constipation treatments, including diet, exercise, and medications, including osmotic purgants and kinetotropic agents. 7. The patient agrees to discontinue any prohibited medications, laxatives (prescription and over-the-counter), fiber supplements, and traditional Chinese medicine prescribed in the study protocol for the treatment of abdominal symptoms and constipation from visit 2 (introductory visit). The exception is remedial drugs, which are provided by the research Center and used in accordance with the investigator's instructions. Patients are not allowed to use the remedy (polyethylene glycol) on or before the start of the treatment period. 8. Patients should agree to follow the dietary guidelines in the applicable chronic constipation treatment guidelines from the screening visit to the end of the study. 9. Be able to collaborate on all research related procedures and use the research diary properly. 10. Possible sacral neuroregulation or voluntary sacral neuroregulation.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of stomach, gallbladder, small or large intestine resection and bariatric surgery (except appendectomy and benign cyst resection). 2. Patients who have had any of the following constipation-related diseases or conditions: pseudoobstruction, colonic weakness, megacolon, megacolon, intestinal obstruction, perineal descent syndrome, isolated rectal ulcer syndrome, and systemic ulcer. 3. Present with constipation caused by anorectal dysfunction or diseases affecting the anorectal region, such as anal fissures, anal fistulas, hemorrhoids grade ?, ?, and hemorrhagic hemorrhoids. 4. Abnormal autonomic reflex. 5. Serious damage to heart and liver function. 6. Lactating patients, patients of childbearing age who plan to become pregnant during the study period or who do not have safe contraception. 7. Complications of uncontrolled infections, tumors and other concomitant diseases that seriously affect health. 8. There is a clotting disorder, or anticoagulant therapy is required and cannot be suspended. 9. Any serious complications or diseases that may prevent the subject from participating in or increase his or her risk of undergoing surgical procedures. 10. Participated in other clinical researchers within 3 months before enrollment. 11. Vulnerable groups, including people with mental illness, those with cognitive impairment, critically ill patients, minors, pregnant women, illiterates, etc. 12. Other situations in which participation in the study was deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of completely spontaneous bowel movements;Spontaneous bowel movements; | — |
Secondary
| Measure | Time frame |
|---|---|
| Constipation Patient Symptom Self-Assessment Scale Score;Quality of Life Scale for Constipation Patients (PAC-QOL) Score;Fecal trait score;Colonic transmission test;Anorectal manometry parameters; | — |
Countries
China
Contacts
Public ContactYu Yanlan
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Outcome results
None listed