antegrade enema
OtherIntroduce 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.
NCT Number: NCT07082699
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Two months after the last enema
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.
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.
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: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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:
Sichuan Cancer Hospital and Research Institute
Other
The Efficacy of Antegrade and Retrograde Enemas in the Management of Low Anterior Resection Syndrome and Improving the Rate of Ileostomy Reversal: A Single-Centre, Prospective Randomised Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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