Anastomotic Leakage, Rectal Cancer
Conditions
Keywords
Rectal cancer, Ultra-low anterior resection, Anastomotic leakage, Severe anastomotic leakage, Diverting stoma, Prophylactic stoma, Somatostatin, Clear liquid diet, Bowel function, Quality of life
Brief summary
The goal of this clinical trial is to learn if somatostatin plus a clear liquid diet can help prevent severe leakage after rectal cancer surgery in adults with low or mid rectal cancer who are scheduled to have ultra-low anterior resection. These patients have a higher risk of leakage where the bowel is joined together after surgery. The main questions it aims to answer are: Does somatostatin plus a clear liquid diet prevent severe leakage within 1 month after surgery about as well as a prophylactic diverting stoma? What medical problems, bowel function problems, recovery outcomes, and quality of life outcomes do participants have after surgery and during follow-up? Researchers will compare somatostatin plus a clear liquid diet without a diverting stoma to prophylactic diverting stoma to see if the somatostatin plus clear liquid diet regimen can provide similar protection against severe leakage while reducing the need for stoma creation. Participants will: Have rectal cancer surgery with the bowel joined very close to the anus Be randomly assigned to receive either somatostatin plus a clear liquid diet for 7 days after surgery without a diverting stoma, or a prophylactic diverting stoma Have follow-up assessments of leakage, postoperative complications, bowel function, recovery quality, and quality of life Complete follow-up visits or assessments for up to 3 years after surgery
Detailed description
This is a multicenter, open-label, randomized clinical trial evaluating a postoperative no-stoma management strategy in adults with low or mid rectal cancer undergoing ultra-low anterior resection. Patients undergoing ultra-low colorectal or coloanal anastomosis are at increased risk of anastomotic leakage. A prophylactic diverting stoma is commonly used to reduce the clinical consequences of leakage, but stoma creation may also lead to stoma-related complications, delayed stoma closure, additional surgery, and impaired quality of life. The study evaluates whether a 7-day postoperative regimen of somatostatin plus a clear liquid diet can serve as an alternative strategy to reduce intestinal contents passing through the anastomosis during the early postoperative period. Somatostatin is used to reduce gastrointestinal secretions, and a clear liquid diet is used to limit solid residue in the digestive tract. The investigational strategy is compared with prophylactic diverting stoma, which is commonly used in patients considered to be at high risk of leakage after low rectal surgery. Eligible participants will be randomly assigned in a 1:1 ratio to one of two treatment strategies after ultra-low anterior resection. Participants in the experimental group will not undergo prophylactic stoma creation and will receive somatostatin plus a clear liquid diet for 7 days after surgery. Participants in the control group will undergo prophylactic diverting stoma and receive standard postoperative care. Both groups will receive routine perioperative management according to clinical practice at the participating centers. The primary clinical focus is severe anastomotic leakage within 1 month after surgery, defined as leakage requiring reoperation. The study will also assess postoperative complications, bowel function, quality of recovery, quality of life, and longer-term functional outcomes during follow-up. Participants will be followed for up to 3 years after surgery. This trial is intended to determine whether somatostatin plus a clear liquid diet without prophylactic stoma can provide similar protection against severe anastomotic leakage compared with prophylactic diverting stoma, while reducing the need for stoma creation and its related burden.
Interventions
DRUGSomatostatin
Participants in the experimental arm will receive somatostatin 3 mg diluted in 50 mL of 0.9% sodium chloride by intravenous infusion pump at 4.1 mL/hour every 12 hours for 7 days after surgery, as part of the postoperative no-stoma management strategy.
OTHERClear Liquid Diet
Participants in the experimental arm will receive a clear liquid diet after recovery of bowel gas passage, as part of the 7-day postoperative no-stoma management strategy. Parenteral nutrition may be provided according to clinical needs.
PROCEDUREProphylactic Diverting Stoma
Participants in the control arm will undergo prophylactic diverting stoma creation during ultra-low anterior resection and will receive standard postoperative care. Somatostatin will not be routinely used unless clinically necessary.
Sponsors
Tongji Hospital
Ezhou Central Hospital
Shanxi Bethune Hospital
Taihe Hospital affiliated to Hubei University of Medicine
Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label trial. Masking is not feasible because the assigned treatment strategies are clinically apparent: participants either undergo prophylactic diverting stoma creation or do not undergo stoma creation and receive postoperative somatostatin plus a clear liquid diet.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups. The experimental group will undergo ultra-low anterior resection without prophylactic stoma and will receive somatostatin plus a clear liquid diet for 7 days after surgery. The control group will undergo ultra-low anterior resection with prophylactic diverting stoma and will receive standard postoperative care.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 to 75 years 2. Patients with stage I to III rectal malignancy who are scheduled to undergo low anterior resection at a participating gastrointestinal surgery center 3. The lower edge of the tumor is 8 cm or less from the dentate line, or 10 cm or less from the anal verge, based on preoperative colonoscopy, imaging, or digital rectal examination 4. The planned anastomosis is expected to be 2 cm or less from the dentate line, or 4 cm or less from the anal verge 5. Patients have two or more risk factors for anastomotic leakage as assessed by the study team 6. American Society of Anesthesiologists physical status classification is grade 3 or lower 7. Body mass index is less than 30 kg/m² 8. The patient, or the patient's legally authorized representative, is willing and able to provide written informed consent
Exclusion criteria
1. Has another colorectal malignant tumor at the same time 2. The final anastomosis after surgery is more than 2 cm from the dentate line, or more than 4 cm from the anal verge 3. Has metastatic disease before surgery 4. Is pregnant 5. Has a mental illness or addictive disorder that would prevent participation in the clinical trial 6. Requires emergency surgery 7. Has inflammatory bowel disease 8. Is allergic to somatostatin or is unable to tolerate somatostatin 9. For participants assigned to the no-stoma group, the surgeon decides that a stoma is required 10. Has received neoadjuvant drug therapy less than 2 weeks before surgery, or radiotherapy less than 8 weeks before surgery 11. Has any other condition that makes it impossible to follow the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade C Anastomotic Leakage Within 1 Month After Surgery | Within 1 month after surgery | Proportion of participants who develop grade C anastomotic leakage within 1 month after surgery. Grade C anastomotic leakage is defined as anastomotic leakage requiring reoperation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Complication Severity Within 1 Month After Surgery | Within 1 month after surgery | Postoperative complications will be assessed within 1 month after surgery using the Clavien-Dindo classification. The highest complication grade for each participant will be recorded, with higher grades indicating more severe postoperative complications. |
| Low Anterior Resection Syndrome Score Within 1 Month After Surgery | 7 days, 14 days, and 1 month after surgery | Bowel dysfunction after low anterior resection will be assessed using the Low Anterior Resection Syndrome score at 7 days, 14 days, and 1 month after surgery. The total score ranges from 0 to 42, with higher scores indicating worse bowel dysfunction. |
| Quality of Recovery Score Within 1 Month After Surgery | 7 days, 14 days, and 1 month after surgery | Quality of postoperative recovery will be assessed using the Quality of Recovery-15 score at 7 days, 14 days, and 1 month after surgery. The total score ranges from 0 to 150, with higher scores indicating better recovery quality. |
Countries
China
Contacts
CONTACTAntian Lu
CONTACTSenyan Lai
Outcome results
None listed