Low Anterior Resection Syndrome
Conditions
Brief summary
The goal of this clinical trial is to learn if enema works to prevent low anterior resection syndrome (LARS) in adults. The main questions it aims to answer are: 1. To describe the level of stoma adaptation before and after the patients received enemas during the stoma period as well as the levels and trends of LARS, bowel function, sleep quality, and quality of life after stoma reduction surgery 2. To compare the effects and advantages and disadvantages of antegrade and retrograde enema, and to investigate whether these two types of enema can provide safe and effective preventive measures for the prevention of LARS, the improvement of bowel function, and the enhancement of sleep and quality of life in rectal cancer patients after low anterior resection. Researchers will compare antegrade enema, retrograde enema, and the standard of care to see if these two types of enema work to prevent LARS. Participants will: 1. Receive either antegrade or retrograde enema or no enema based on the standard of care at 1 month after anterior rectal resection, until the ileostomy reversal. 2. Keep a diary of their symptoms.
Interventions
OTHERtransanal irrigation
The enema is administered retrogradely via the anus. The enema commences one month post-operatively for patients with well-healed wounds, absence of stoma-related complications, and no evidence of anastomotic leakage upon digital examination, until ileostomy reversal. the catheter is gently and slowly inserted 7-10 cm through the anus. The initial irrigation volume is set at 500 ml and is gradually increased based on the patient's tolerance, up to a maximum of 1000 ml. 39-41°C warm water is the choice. Enemas are administered twice weekly, with each session limited to a duration of 30 minutes.
OTHERantegrade enema
The enema is administered through the distal end of the ileocecal stoma, directed towards the anus. The enema commences one month post-operatively for patients with well-healed wounds, absence of stoma-related complications, and no evidence of anastomotic leakage upon digital examination, until ileostomy reversal. Using a disposable catheter, insert it about 20 cm. The initial irrigation volume is set at 500 ml and is gradually increased based on the patient's tolerance, up to a maximum of 1000 ml. 39-41°C warm water is the choice. Enemas are administered twice weekly, with each session limited to a duration of 30 minutes.
Sponsors
Sichuan Cancer Hospital and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Based on the NCCN guidelines for the pathological diagnosis of rectal cancer, patients are identified as having Primary Rectal Adenocarcinoma. * ≥18 years. * For the first time, anterior rectal dissection combined with prophylactic ileostomy was performed using laparoscopic, robotic, and open techniques. * The patient exhibits normal cognitive and expressive abilities. * Informed consent was obtained for voluntary participation in the study.
Exclusion criteria
* American Society of Anesthesiologists (ASA) Class III or higher. * A combination of other intestinal conditions, including inflammatory bowel disease and Crohn's disease. * Mental disorders and prolonged use of psychotropic medications. * The presence of contraindications to enema administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| low anterior resection syndrome score (LARS score) | Pre-discharge, 1 month, 2 months, 3 months, 6 months after ileostomy reversal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bowel function | before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal | Memorial Sloan Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI) |
| quality of life for rectal cancer patients | before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal | quality of life will be measured using the EORTC Colorectal Cancer Module QLQ-CR29 (EORTC QLQ-CR29 ) |
| quality of sleep | before anterior rectal resection, before starting enemas 1 month postoperatively, 2 months, 3-4 months postoperatively; 1 month, 2 months, 3 months, 6 months after stoma reduction | Pittsburgh Quality Index (PSQI) |
Other
| Measure | Time frame |
|---|---|
| A quality of life questionnaire for people with an ostomy (Stoma-QoL) | 1 month after anterior rectal resection before starting enemas, 2 months and 3-4 months postoperatively |
| Anal drainage and irritation during ileostomy (self-made) | 1 month after anterior rectal resection before starting enemas, 2 months and 3-4 months postoperatively |
| Ostomy Adjustment Inventory-20 (OAI-20) | 1 month after anterior rectal resection before starting enemas, 2 months and 3-4 months postoperatively |
Countries
China
Contacts
Primary ContactHai Hu, M.D.
Outcome results
None listed