Clinical trial · Observational
A Prospective Multi-Center Research on Bowel Dysfunction After Sphincter Preservative Surgery
A Prospective, Randomization and Clinic Cohort Observational Study From Multi Institutions on Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation
NCT03009747CI-TRIAL-00025327PMCRBDSPSunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research plans to collect rectal cancer patients after sphincter-preserving surgery from 14 institutions in China mainland, observe the incidence and risk factors about bowel dysfunction after operation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bowel Dysfunction | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- sphincter-preserving surgery
- description
- Patients meet the inclusion criteria will be enrolled into this observing group
Primary outcomes (2)
- measure
- Incidence of bowel dysfunction after sphincter-preserving surgery
- timeFrame
- one year
- measure
- Risk factors of bowel dysfunction after sphincter-preserving surgery
- timeFrame
- one year
Secondary outcomes (3)
- measure
- Incidence of each symptoms of bowel dysfunction
- timeFrame
- one year
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years 2. Adenocarcinoma confirmed by pathology 3. Distance from the lowest margin of tumor to the anal verge is ≤ 12cm, confirmed by hard sigmoidoscope. 4. The tumor is estimated to be resectable and confirmed by multidisciplinary team (MDT). 5. The operation is estimated to be sphincter-preserving. 6. The Eastern Cooperative Oncology Group(ECOG) performance status score of patient is ≤ 2. 7. The estimated life time is not less than one year. 8. The patient agree to sign the informed consent. Exclusion Criteria: 1. The patient refuse to follow research plan. 2. Emergency case 3. Pregnant and lactating female patient 4. The patient did not accept radical resection. 5. The patient did not accept first stage resection and anastomosis. 6. The patient has experienced anal-rectal surgery. 7. The patient has experienced left colon surgery. 8. The patient suffered long-existing bowel dysfunction before rectal cancer diagnosis. 9. The patient was diagnosed with cognitive or communicative obstacles. 10. The patient was diagnosed with serious repeated infection or other concomitance diseases. 11. The patient has participated other medical research which may affect his/her bowel function.
References
Publications (1)
- DERIVEDLiu F, Guo P, Su X, Cui M, Jiang J, Wang S, Yu Z, Zhou R, Ye Y. A Novel Remote Follow-Up Tool Based on an Instant Messaging/Social Media App for the Management of Patients With Low Anterior Resection Syndrome: Pilot Prospective Self-Control Study. JMIR Mhealth Uhealth. 2021 Mar 19;9(3):e22647. doi: 10.2196/22647. PMID 33739295