Rectal cancer
Conditions
Interventions
Vitamin B1 group:Beginning at 8 hours after the completion of the index total mesorectal excision (TME), patients in the intervention group received intramuscular injection of 100 mg vitamin B1 (thiam
Blank control group:None
Sponsors
The Sixth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants were eligible for enrollment only if they met "all" of the following criteria at the time of screening: 1. Newly diagnosed, treatment-naive patients aged 18 to 75 years; 2. Patients or their legally authorized representatives (LARs) are able to fully comprehend the study protocol, voluntarily agree to participate in this trial, and provide written informed consent prior to the performance of any study-related procedures; 3. American Society of Anesthesiologists (ASA) physical status classification grade I to III; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 4. Histopathologically confirmed rectal adenocarcinoma via colonoscopic biopsy, including the following histological subtypes: tubular adenocarcinoma, papillary adenocarcinoma, mucinous adenocarcinoma, and signet-ring cell carcinoma; 5. Patients with preoperatively clinically staged T1-T3, node-positive (N+), non-metastatic (M0) rectal cancer, in accordance with the 8th edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, and who are scheduled to undergo standardized total mesorectal excision (TME).
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Patients who met the following criteria at enrollment were excluded from the trial 1) long-term drinking history; 2) pregnancy or lactation; 3) planned epidural anesthesia; 4) known or suspected allergy to vitamin B1; 5) plan for local or systemic continuous vitamin B1 infusion concurrently with vitamin B1 intramuscular injection; 6) patients with rectal cancer who had received any neoadjuvant radiotherapy; 7) prior rectal surgery, or signs of acute intestinal obstruction or concurrent abdominal surgery; 8) history of FAP, active IBD, or other cancers within 5 years; 9) forming a preoperative surgical plan for any new stoma during the primary surgery; 10) current severe liver dysfunction (Child grade A or above) and renal failure (eGFR<30); 11) any psychological, family, social or geographic conditions that may prevent adherence to the study protocol or follow-up plan; 12) participated in other drug or device trials at the time of enrollment or during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achieved GI-3 recovery by 72h after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to GI-3 recovery;Time to GI-2 recovery;Prolonged postoperative Ileus;Comprehensive Complication Index (CCI) within 30 days postoperatively;Incidence of Vitamin B1 (Thiamine);Time to first flatus;Time to first defecation;Time to tolerance of solid oral diet ;Postoperative length of hospital stay (LOS) after the index TME procedure;Postoperative hospitalization costs ;Intraoperative opioid analgesia;OBAS score;Quality of Recovery–15;Quality of life (EQ-5D-5L);Time to meet clinician-assessed medical criteria for discharge from hospital;Time to patient-assessed fitness for discharge from hospital;Enhanced recovery perioperative procedures; | — |
Countries
China
Contacts
Public ContactLiang Kang
The Sixth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed