Clinical trial · Observational
Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer
Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer: A Multicenter Prospective Cohort 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)
RATIONALE: Colorectal cancer is one of the most common cancers. However, approaches to minimize surgical trauma, preserve anal function, avoid abdominal stoma, and improve quality of life for patients with ultralow rectal cancers were limited. Thus, new technologies are urgently needed to improve the anal preservation rate, reduce the incidence of anastomotic leakage and improve postoperative anal function in patients with ultralow rectal cancer. PURPOSE: This one-arm multicenter prospective cohort study aims to collect the data of patients with ultralow rectal cancer who undergo sphincter-preserving surgeries, including modified PPS and conventional surgeries, then compare the effects of different operations on clinical outcomes and to see the efficacy and safety of modified PPS surgery when compared with conventional procedures in the treatment of ultralow rectal cancer.
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 |
|---|---|---|---|
| Faecal Incontinence | — | UNRESOLVED | — |
| Leakage, Anastomotic | — | UNRESOLVED | — |
| Rectum Cancer | Rectal Carcinoma | ALIAS | 0.90 |
| Stoma Colostomy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- PPS surgery
- description
- Patients who undergo modified PPS surgery in order to preserve anal sphincter function under the premise of radical resection of ultralow rectal cancer.
- label
- Conventional
- description
- Patients who undergo conventional sphincter-preserving surgeries.
Primary outcomes (4)
- measure
- Rate of temporary defunctioning stoma
- timeFrame
- Within 30 days after operation
- description
- The percentage of patients who get temporary defunctioning stoma to limit the consequences of anastomotic leakage.
- measure
- The percentage of patients who develop anastomotic leakage
- timeFrame
- Within 30 days after operation
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological proof of newly diagnosed primary adenocarcinoma of the rectum 2. The lower edge of tumor \< 3 cm from the dentate line 3. Clinical T stage ≤ T3 Exclusion Criteria: 1. The lower edge of tumor \< 1 cm from the dentate line 2. Locally advanced stage of tumor 3. Presence of metastatic disease or recurrent rectal tumor 4. Concomitant malignancies 5. Concurrent uncontrolled medical conditions 6. Impaired anal function before surgery 7. Presence of acute bowel obstruction or bowel perforation caused by cancer 8. Pregnancy or breast feeding
References
Publications (0)
Data not yet available