Clinical trial · Interventional
CRP-guided Transanal Drainage Removal 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Transanal drainage tube (TDT) has the benefit of reducing intraluminal pressure after rectal surgery and may provide ideal regional environment for anastomotic healing. Postoperative C-reactive protein (CRP) trajectory has a high negative predictive value of 0.99 for ruling out anastomotic leak (AL). Previously, TDT was removed at the surgeon's own discretion. In the present study, we design a single arm study to investigate the safety and efficacy of CRP-guided TDT removal for AL prevention following laparoscopic anterior resection for rectal carcinoma
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| removal of transanal drainage tube | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- patients with TDT removal guided by postoperative CRP trajectory
- interventionNames
- Device: removal of transanal drainage tube
Primary outcomes (1)
- measure
- anastomotic rate
- timeFrame
- 30 days after surgery
- description
- anastomotic rate
Secondary outcomes (4)
- measure
- the grades of anastomotic leak
- timeFrame
- 30 days after surgery
- description
- The severity grading of anastomotic leak according to the International Study Group of Rectal Cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available