LARS - Low Anterior Resection Syndrome
Conditions
Brief summary
Anterior rectal resection has become the primary surgical treatment for rectal cancer. However, studies have reported that up to 80%-90% of patients who undergo anterior rectal resection experience varying degrees of defecation dysfunction after surgery, such as frequent bowel movements, urgent bowel movements, and faecal incontinence, known as low anterior resection syndrome (LARS). This can lead to a decline in quality of life after surgery and even partial loss of social functioning.
Interventions
OTHERantegrade enema
Introduce saline at a flow rate of 40 ml/minute through the distal end of the ileostomy. The initial enema volume is approximately 500 ml, with a maximum of 1000 ml. Perform twice weekly for one month.
OTHERretrograde enema
Introduce saline at a flow rate of 40 ml/minute through the anus. The initial enema volume is approximately 500 ml, with a maximum of 1000 ml. Perform twice weekly for one month.
Sponsors
Sichuan Cancer Hospital and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. According to the NCCN guidelines for the pathological diagnosis of rectal cancer, the patient has primary rectal adenocarcinoma; 2. Age ≥ 18 years; 3. Previously underwent rectal resection with prophylactic ileostomy via laparoscopy, robotics, or open surgery; 4. Expected to undergo ileostomy reversal surgery within 1-2 months; 5. Possesses normal cognitive and communication abilities; 6. Voluntarily participates in this study and has signed an informed consent form.
Exclusion criteria
1. American Society of Anesthesiologists (ASA) classification III or higher; 2. Concurrent inflammatory bowel disease, Crohn's disease, or other intestinal diseases; 3. Mental disorders, long-term use of psychiatric drugs; 4. Contraindications to enemas.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of ileostomy reversal | Two months after the last enema | — |
| low anterior resection syndrome score (LARS score) | Evaluations were conducted one day before enema, one month after enema, one month, two months, three months, and six months after stoma closure. | The LARS score consists of five components and the total score, ranging from 0 to 42. Severity levels are categorized as follows: no LARS (0-20 points), minor LARS (21-29 points), and major LARS (30-42 points). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bowel function | one month, two months, three months, and six months after stoma closure. | The Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (MSKCC BFI) is used to assess bowel function. This questionnaire comprises three dimensions, totaling 18 items. The total scale score ranged from 18 to 90, with higher scores indicating better bowel function. |
| quality of sleep | Evaluations were conducted one day before enema, one month after enema, one month, two months, three months, and six months after stoma closure. | Quality of sleep was evaluated by Pittsburgh Quality Index (PSQI). The PSQI assesses a participant's sleep quality in the previous month using 18 items divided into 7 components. Each component is graded between 0 and 3. The total score is 0-21, with higher scores indicating poorer sleep quality. |
| cancer patients' quality of life | one month, two months, three months, and six months after stoma closure. | The quality of life was assessd by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29). The scale includes 4 functional domains, 19 symptom domains, and 6 stoma-related items. Each item, except for item 18 (which indicates the presence or absence of a stoma), is rated on a 4-point scale: 'not at all,' 'a little,' 'quite a bit,' and 'very much,' corresponding to scores of 1 to 4, respectively. Scores are converted into standardized values ranging from 0 to 100 using polarization. Higher scores in the functional domains indicate better function, whereas higher scores in the symptom domains reflect more severe symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Stoma-Specific Quality of Life | Evaluate one day before starting enemas and one month after enemas before performing stoma closure. | The Stoma-Specific Quality of Life-Questionnaire (Stoma QoL) was designed specifically for patients with ostomy and consists of 20 entries, each of which is divided into 4 levels: always, sometimes, rarely, never, with a score ranging from 1 to 4. The ratings range from 20 to 80, with higher levels indicating higher HRQoL. |
| Observation chart for anal excretion and irritation symptoms during ostomy (self-made) | Evaluate one day before starting enemas and one month after enemas before performing stoma closure | This was designed to assess anal feces and discomfort sensations in stoma patients during their stoma time. The questionnaire consisted of four main questions dealing with frequency of defecation, perception of bowel movement, sensation of irritation in the anal region, and the patient's reaction to irritants. These four specific questions as follow: 1. In the last week, how often have you felt discharge oozing from around your anus? 2. In the last week, how often have you felt a bowel movement around your anus? 3. In the last week, how often have you felt irritation in your bowel movements? 4. Do you experience skin irritation or discomfort from anal discharge? (five-point scale: very, rather, generally, somewhat, not at all) |
| The psychosocial adjustment level of patients with enterostomy | Evaluate one day before starting enemas and one month after enemas before performing stoma closure. | The psychosocial adjustment level of patients with enterostomy were evaluated using the Ostomy Adjustment Inventory-20 (OAI-20). OAI-20 adopts a 5-level Likert scoring method, forward scores range from 0 (strongly disagree) to 4 (strongly agree), while reverse scores range from 4 (strongly disagree) to 0(strongly agree). Total scores range from 0 to 80, where scores \<40 indicate low psychosocial adjustment, scores between 40 and 59 indicate medium psychosocial adjustment, and scores ≥60 indicate high psychosocial adjustment levels. |
Outcome results
None listed