Faecal Incontinence, Faecal Incontinence with Faecal Urgency, Leakage, Anastomotic, Low Anterior Resection Syndrome, Rectum Cancer
Conditions
Brief summary
The occurrence of colorectal cancer has increased from the third most common cancer in 2018 to the second most common cancer in 2023. The practice of anal preservation surgery for ultra-low rectal cancer is being adopted gradually. Ultra-low rectal cancer patients who have undergone anal preservation are at an increased risk of developing significant bowel complications. The objective of this study was to examine the relationship between the type of bowel reconstruction following anal preservation surgery, and the subsequent outcomes of bowel function, quality of life and complication rates in patients with ultra-low rectal cancer.
Interventions
PROCEDUREJ-pouch anastomosis
Patient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage anastomosis using a colon J-pouch.
PROCEDUREdirect anastomosis
Patient with ultra-low rectal cancer undergoing Sphincter- preserving surgery with one-stage direct anastomosis.
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. A confirmed diagnosis of intestinal cancer, with the lower edge of the tumour <5 cm from the anus or <3 cm from the dentate line, and treated with anus-preserving surgery; 2. No distant metastasis; 3. Age >18 years old; 4. Voluntary enrollment in the study and signing of an informed consent.
Exclusion criteria
1. A combination of severe cardiopulmonary, hepatic, renal, and other underlying diseases with a greater anaesthetic risk (ASA ≥ grade 4); 2. preoperative anal stenosis and anal nonfunction; 3. temporary stoma diversion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LARS score | From 1 month postoperatively to 12 months postoperatively | The LARS scale has five questions with a total score of 42. A score of 0-20 lacks diagnostic value for LARS, while a score of 21-29 indicates mild LARS and a score above 29 indicates major LARS. |
| FIQL | From 1 month postoperatively to 12 months postoperatively | The FIQL is a specific quality-of-life assessment scale applicable to the symptoms of colorectal cancer patients. It comprises 29 items, which are divided into four dimensions: lifestyle (10 items), coping/behavior restriction(9 items), depression/self-perception (7 items), and embarrassment (3 items). |
| Vaizey score | From 1 month postoperatively to 12 months postoperatively | The Wexner scale has five parts with a total score of 20, while the Vaizey scale is further refined on the basis of Wexner and has seven parts with a total score of 24. Higher scores on these scales indicate poorer anal functioning. |
| Wexner score | From 1 month postoperatively to 12 months postoperatively | The Wexner scale has five parts with a total score of 20, while the Vaizey scale is further refined on the basis of Wexner and has seven parts with a total score of 24. Higher scores on these scales indicate poorer anal functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical complications | From 1 month postoperatively to 12 months postoperatively | Records post-operative anastomotic fistula, infection, bleeding, etc. |
Countries
China
Outcome results
None listed