The Efficacy of Antegrade and Retrograde Enemas Management in Low Anterior Resection Syndrome and Improving the Rate of Ileostomy Reversal

N/ANot Yet RecruitingNCT07082699

Sichuan Cancer Hospital and Research Institute72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

LARS - Low Anterior Resection Syndrome

Interventions

antegrade enema

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Success rate of ileostomy reversal

Time frame: Two months after the last enema

low anterior resection syndrome score (LARS score)

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).

Time frame: Evaluations were conducted one day before enema, one month after enema, one month, two months, three months, and six months after stoma closure.

Secondary Outcomes

quality of sleep

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.

Time frame: Evaluations were conducted one day before enema, one month after enema, one month, two months, three months, and six months after stoma closure.

bowel function

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.

Time frame: one month, two months, three months, and six months after stoma closure.

cancer patients' quality of life

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.

Time frame: one month, two months, three months, and six months after stoma closure.