Rectal Neoplasms Clinical Trial
— THREESTAPLEROfficial title:
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
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.
Status | Recruiting |
Enrollment | 154 |
Est. completion date | October 1, 2020 |
Est. primary completion date | October 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Clinic of Colorectal and Minimally Invasive Surgery - I.M. Sechenov First Moscow State Medical University | Moscow |
Lead Sponsor | Collaborator |
---|---|
Russian Society of Colorectal Surgeons | I.M. Sechenov First Moscow State Medical University, Meril Life Sciences Pvt. Ltd. |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anastomotic leakage rate | The rate of colorectal anastomosis dehiscence documented with an X-ray and/or CT scan | 6 weeks | |
Secondary | Operating time | The duration of surgical procedure in minutes | 1 day | |
Secondary | Circular stapler misfunction rate | The rate of circular stapler inability to create a colorectal anastomosis in a way declared by the manufacturer | 1 day | |
Secondary | Anastomotic bleeding rate | The rate of bleeding from the line of stapled anastomosis verified by proctoscopy | 30 days | |
Secondary | Re-intervention rate | The rate of repeat surgeries due to anastomotic leakage | 6 weeks | |
Secondary | Early postoperative complications rate | The rate of complications in first 30 days after surgery | 30 days | |
Secondary | The postoperative hospital stay | The number of days from the first day after operation to discharge | 1 month | |
Secondary | Complications of defunctioning stoma | The rate of complications related to defunctioning stoma | 3 months | |
Secondary | Overall quality of life | Assessed with patient-reported questionnaire SF-36. A total score in each of 8 sections will be calculated and transformed into a 0-100 scale with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability | 7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery | |
Secondary | Cancer-related quality of life | Assessed with patient-reported questionnaire EORTC QLQ-C30 with supplementary module EORTC QLQ-CR29. A total score in each of 4 modules (functional scale, global health status, symptom scale, colorectal cancer module) will be calculated and transformed into a 0-100 scale. For Functional scale, Global health status scale and Colorectal cancer module a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. For Symptom scale a score of 100 is equivalent to maximum disability and a score of 0 is equivalent to no disability. | 7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery | |
Secondary | Manifestation of Low Anterior Resection Syndrome (LARS) | Assessed with patient-reported questionnaire LARS, total score will be calculated (min 0, max 42) for each patient and also each patient will be assigned to either "no LARS" group (total score 0-20), or "minor LARS" group (total score 21-29) or "major LARS" group (total score 30-42) | 7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery | |
Secondary | Adverse events rate | The rate of adverse events related to circular stapler usage | 12 months | |
Secondary | Serious adverse events rate | The rate of serious adverse events related to circular stapler usage | 12 months |
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