Clinical trial · Interventional
THREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer
Uni-center, Patient-blinded, Randomized, 12 Month, Parallel-group, Non-inferiority Study to Compare Outcomes of Three-row Versus Two-row Circular Staplers for Colorectal Anastomosis Formation After Low Anterior Resection for Rectal Cancer
- 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)
This trial aims to assess safety and efficacy of three-row circular staplers compared to two-row surgical stapllers in short-term and long-term perspective in patients with rectal cancer undergoing low anterior resection with stapled colorectal anastomosis. All the patients will undergo a low anterior resection. In a half of patients a colorectal anastomosis will be created with a three-row surgical circular stapler. In another half of patients a colorectal anastomosis will be created with a two-row surgical circular stapler.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomosis | — | UNRESOLVED | — |
| Anastomotic Complication | — | UNRESOLVED | — |
| Anastomotic Haemorrhage | — | UNRESOLVED | — |
| Anastomotic Leak | — | UNRESOLVED | — |
| Anastomotic Stenosis | — | UNRESOLVED | — |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Staple Misfire | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Three-row circular stapler | Device | — | UNRESOLVED |
| Two-row circular stapler | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Two-row anastomosis
- description
- Colorectal anastomosis is created with a two-row circular surgical stapler
- interventionNames
- Device: Two-row circular stapler
- type
- EXPERIMENTAL
- label
- Three-row anastomosis
- description
- Colorectal anastomosis is created with a three-row circular surgical stapler
- interventionNames
- Device: Three-row circular stapler
Primary outcomes (1)
- measure
- Anastomotic leakage rate
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated consent to comply with all study procedures and availability for the duration of the study 3. Male or female 4. For females of reproductive potential: not pregnant at the time of screening 5. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner 6. Histologically proven primary rectal adenocarcinoma located within 5 to 15 cm from anal verge not involving internal and/or external sphincter muscle Non-inclusion Criteria: 1. Current use of antiplatelet drugs, acetylsalicylic acid or anticoagulants within 7 days prior to intervention 2. Unresectable tumour, inability to perform a TME with colorectal anastomosis, inability to complete R0 resection or presence of T4b tumour necessitating a multi-organ resection 3. Inability to save the left colic artery 4. Diameter of rectal lumen is unable to contain the working part of the stapler 5. Infection requiring antibiotic treatment within 30 days prior to intervention 6. Anal incontinence prior to surgery (Wexner Continence Grading Scale \>=10) 7. Significant comorbidities - ASA \> III Exclusion criteria: 1. Patient lost for observation 2. Inability to complete all the trial procedures 3. Death due to causes unrelated to anastomotic leak in early postoperative period 8\. Current smoker or tobacco use within \<specify timeframe\> 9. Patient wants to withdraw from the clinical trial
References
Publications (2)
- DERIVEDTulina I, Tsugulya P, Kim V, He M, Balaban V, Tsarkov P. Short- and Long-term Outcomes of Three-Row Versus Two-Row Circular Staplers for Low Colorectal Anastomosis After Total Mesorectal Excision: A Single-Center, Randomized, Single-Blind, Phase III Trial (THREESTAPLER Study). Dis Colon Rectum. 2026 Aug 10. doi: 10.1097/DCR.0000000000004381. Online ahead of print. PMID 42572962
- DERIVEDNekliudov NA, Tsarkov PV, Tulina IA. Uni-center, patient-blinded, randomized, 12-month, parallel group, noninferiority study to compare outcomes of 3-row vs 2-row circular staplers for colorectal anastomosis formation after low anterior resection for rectal cancer. Medicine (Baltimore). 2019 Jun;98(24):e15978. doi: 10.1097/MD.0000000000015978. PMID 31192938