Clinical trial · Interventional
Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer
Comparison of Postoperative Anal Function Between Different Anastomosis Techniques(Parks Versus Bacon) in Low Rectal Cancer: A Prospective, Multicentric and Randomized Controlled Study
- 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)
The goal of this study is to compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life. The main questions it aims to answer are: the difference of anal function 1 year after surgery type of study: clinical trial participant population: patients with low rectal cancer Participants will receive Parks operation of Bacon operation If there is a comparison group: Researchers will compare Parks and Bacon operation to see if the anal function 1 year after surgery is different.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Low Anterior Resection Syndrome | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bacon technique | Procedure | — | UNRESOLVED |
| Parks technique | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Parks technique
- description
- patients receive coloanal anastomosis operation
- interventionNames
- Procedure: Parks technique
- type
- EXPERIMENTAL
- label
- Bacon technique
- description
- patients receive coloanal pull-out anastomosis operation
- interventionNames
- Procedure: Bacon technique
Primary outcomes (1)
- measure
- Low Anterior Resection Syndrome (LARS) score 1 year after surgery
- timeFrame
- 1 year after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men or women, aged between 18 and 75 years; 2. Pathological diagnosis of rectal cancer before operation, with the distance from the lower edge of the tumor to the dentate line ≤ 3cm by MR imaging; 3. No local complications (including complete/ incomplete obstruction, active bleeding, local invasion of sphincter or levator ani, etc.) before operation; 4. Suitable for anal preservation surgery discussed by MDT; 5. Adequate bone marrow, liver, renal and cardiac function meeting the requirements of surgery and anesthesia; 6. R0 resection is expected technically; 7. Provision of written informed consent. Exclusion Criteria: 1. Previous history of malignant colorectal tumors; 2. Complications such as obstruction and gastrointestinal bleeding that need an emergency operation; 3. Unachievable R0 resection due to invasion of adjacent organs by primary tumor; 4. Multiple primary tumors; 5. History of other malignancy; 6. Participation in other clinical trials within the previous 4 weeks of enrollment; 7. ASA physical status score ≥ IV level and/or ECOG performance status ≥ 2; 8. Intolerance of surgery due to liver, renal, cardiopulmonary or coagulation dysfunction, or underlying diseases; 9. History of serious mental disorders; 10. Women in pregnancy or lactation period; 11. Uncontrolled infection before operation; 12. Unsuitable to be included due to other clinical and laboratory conditions by the judgement of investigators.
References
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