THREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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A low anterior resection for rectal cancer in most cases results in creating a colorectal anastomosis with a surgical circular stapler device. Using a disposable circular stapler with two rows of staples is standard of care nowadays. Colorectal anastomosis dehiscence and subsequent anastomotic leak in postoperative period happens in 5-25% of cases and is a major and life-threatening complication. Thus different improvements to the procedure of creating a colorectal anastomosis are being proposed. One of them is utilizing a three-row instead of a two-row surgical circular stapler. A three-row surgical stapler has recently been registered and approved for clinical use in Russia. The primary purpose of this study is to find out the rate of colorectal anastomosis leakage when using a three-row circular stapler and to demonstrate that it is at least not bigger than the rate of colorectal anastomosis leakage when using a two-row circular stapler.

Official Title
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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

Conditions
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Anastomotic Leak, Anastomotic Haemorrhage, Anastomotic Complication, Rectal Neoplasms, Staple Misfire, Anastomosis, Anastomotic Stenosis

Intervention / Treatment
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* Device: Three-row circular stapler
* Device: Two-row circular stapler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated consent to comply with all study procedures and availability for the duration of the study Male or female For females of reproductive potential: not pregnant at the time of screening For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner 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: Current use of antiplatelet drugs, acetylsalicylic acid or anticoagulants within 7 days prior to intervention 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 Inability to save the left colic artery Diameter of rectal lumen is unable to contain the working part of the stapler Infection requiring antibiotic treatment within 30 days prior to intervention Anal incontinence prior to surgery (Wexner Continence Grading Scale >=10) Significant comorbidities - ASA > III Exclusion criteria: Patient lost for observation Inability to complete all the trial procedures 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Two-row anastomosis<br>Colorectal anastomosis is created with a two-row circular surgical stapler | Device: Two-row circular stapler<br>* Para-aortic lymph node dissection, inferior mesenteric artery skeletonisation and ligation below left colic artery origin, nerve-preserving total mesorectal excision, rectum division with a linear stapler, sigmoid colon division and circular stapler envil fixation with a purse-string suture, end-to-end colorectal anastomosis creation with a two-row circular stapler, defunctioning colostomy is performed.<br>* Other names: Ethicon 29mm Curved Intraluminal Stapler (CDH29A);|
| Experimental: Three-row anastomosis<br>Colorectal anastomosis is created with a three-row circular surgical stapler | Device: Three-row circular stapler<br>* Para-aortic lymph node dissection, inferior mesenteric artery skeletonisation and ligation below left colic artery origin, nerve-preserving total mesorectal excision, rectum division with a linear stapler, sigmoid colon division and circular stapler envil fixation with a purse-string suture, end-to-end colorectal anastomosis creation with a three-row circular stapler, defunctioning colostomy is performed.<br>* Other names: MirusTM Disposable Circular Stapler 3 Row 29 (MCS-29R3);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic leakage rate | The rate of colorectal anastomosis dehiscence documented with an X-ray and/or CT scan | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time | The duration of surgical procedure in minutes | 1 day | 
| Circular stapler misfunction rate | The rate of circular stapler inability to create a colorectal anastomosis in a way declared by the manufacturer | 1 day | 
| Anastomotic bleeding rate | The rate of bleeding from the line of stapled anastomosis verified by proctoscopy | 30 days | 
| Re-intervention rate | The rate of repeat surgeries due to anastomotic leakage | 6 weeks | 
| Early postoperative complications rate | The rate of complications in first 30 days after surgery | 30 days | 
| The postoperative hospital stay | The number of days from the first day after operation to discharge | 1 month | 
| Complications of defunctioning stoma | The rate of complications related to defunctioning stoma | 3 months | 
| 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 | 
| 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 | 
| 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 | 
| Adverse events rate | The rate of adverse events related to circular stapler usage | 12 months | 
| Serious adverse events rate | The rate of serious adverse events related to circular stapler usage | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anastomosis, Anastomotic leakage, Rectal cancer, Total mesorectal excision, Low anterior resection, Anastomotic leak, Colorectal anastomosis, Three-row stapler