Faecal Incontinence, Leakage, Anastomotic, Rectum Cancer, Stoma Colostomy
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Shanghai 10th People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of temporary defunctioning stoma | Within 30 days after operation | The percentage of patients who get temporary defunctioning stoma to limit the consequences of anastomotic leakage. |
| The percentage of patients who develop anastomotic leakage | Within 30 days after operation | The percentage of patients who develop anastomotic leakage |
| Postoperative anal function assessed by Wexner scale | 2 years since the start of treatment | Ranging from 0 (perfect continence) to 20 (complete incontinence) |
| Postoperative anal function assessed by Vaizey scale | 2 years since the start of treatment | Ranging from 0 (perfect continence) to 24 (complete incontinence) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-Day Readmission Rate | Within 30 days after operation | Percentage of readmitted patients within 30 days after operation |
| Rate of sphincter-preservation rates | Within 30 days after operation | The percentage of patients who preserve the anatomical structure of the anus |
| Overall survival | Up to 5 years after the last patient recruited | Overall survival is defined as the time from surgery until death from any cause. |
| Disease-free survival | Up to 5 years after the last patient recruited | Disease-free survival is defined as the time from surgery to recurrence of tumor or death |
| The number of short-term postoperative complications | Within 30 days after operation | The number of grade II and higher postoperative complications according to the Clavien-Dindo classification |
| Postoperative hospital stay | Within 30 days after operation | The time between the operation date and the discharge date. |
| Hospitalization costs | Within 30 days after operation | The total cost of hospitalization |
Countries
China
Contacts
Primary ContactCheng-Le Zhuang, MD, PhD
Outcome results
None listed