Guided removal of drainage tubes after rectal surgery
A Single Arm Study to Investigate the Safety and Efficacy of C Reactive Protein (CRP) Guided Transanal Drainage Tube (TDT) Removal for Anastomotic Leak (AL) Prevention Following Laparoscopic Anterior Resection for Rectal Carcinoma
This study tests if using C-reactive protein levels can help determine the safest time to remove drainage tubes after rectal surgery for cancer, aiming to improve recovery for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05502354 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of removing transanal drainage tubes based on C-reactive protein (CRP) levels after laparoscopic anterior resection for rectal cancer. The approach aims to prevent anastomotic leaks by utilizing CRP as a predictive marker for safe drainage tube removal. By monitoring postoperative CRP trajectories, the study seeks to establish a more reliable method for determining the optimal timing for tube removal, potentially improving patient outcomes. This is a single-arm interventional study focusing on patients undergoing rectal surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with primary rectal adenocarcinoma undergoing laparoscopic anterior resection.
Not a fit: Patients who have undergone emergency operations or have severe postoperative complications unrelated to anastomotic leaks may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of anastomotic leaks and improve recovery outcomes for patients undergoing rectal surgery.
How similar studies have performed: While the use of CRP as a predictive marker is established, this specific approach to CRP-guided drainage tube removal is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age from 18 to 75 years old * male and female * primary rectal adenocarcinoma * ASA I, II, or III * laparoscopic LAR + DST * with or without preoperative radio- or chemotherapy * no distal metastasis * no preoperative bowel obstruction * no preventive ileostomy or colostomy * patients and their families can understand and are willing to participate in this study and provide written informed consent Exclusion Criteria: * emergency operation * preoperative abnormal liver function * tatme or ISR procedure (healing process might differ from anterior resection) * severe postoperative (Clavien-Dindo grade III IV V) complications other than anastomotic leak * severe perioperative infection unrelated to anastomotic leak * patients with serious mental illness * pregnant or breastfeeding women * patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Xiang Zhang, M.D. Ph.D.
- Email: xiang.zhang02@hotmail.com
- Phone: +8618560089182
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.