Back to resultsTHREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer (THREESTAPLER)
Primary Purpose
Anastomotic Leak, Anastomotic Haemorrhage, Anastomotic Complication
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Three-row circular stapler
Two-row circular stapler
Sponsored by
About this trial
This is an interventional treatment trial for Anastomotic Leak focused on measuring Anastomosis, Anastomotic leakage, Rectal cancer, Total mesorectal excision, Low anterior resection, Anastomotic leak, Colorectal anastomosis, Three-row stapler
Eligibility Criteria
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
Sites / Locations
- Clinic of Colorectal and Minimally Invasive Surgery - I.M. Sechenov First Moscow State Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Two-row anastomosis
Three-row anastomosis
Arm Description
Colorectal anastomosis is created with a two-row circular surgical stapler
Colorectal anastomosis is created with a three-row circular surgical stapler
Outcomes
Primary Outcome Measures
Anastomotic leakage rate
The rate of colorectal anastomosis dehiscence documented with an X-ray and/or CT scan
Secondary Outcome Measures
Operating time
The duration of surgical procedure in minutes
Circular stapler misfunction rate
The rate of circular stapler inability to create a colorectal anastomosis in a way declared by the manufacturer
Anastomotic bleeding rate
The rate of bleeding from the line of stapled anastomosis verified by proctoscopy
Re-intervention rate
The rate of repeat surgeries due to anastomotic leakage
Early postoperative complications rate
The rate of complications in first 30 days after surgery
The postoperative hospital stay
The number of days from the first day after operation to discharge
Complications of defunctioning stoma
The rate of complications related to defunctioning stoma
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
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.
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)
Adverse events rate
The rate of adverse events related to circular stapler usage
Serious adverse events rate
The rate of serious adverse events related to circular stapler usage
Full Information
NCT ID
NCT03910699
First Posted
April 8, 2019
Last Updated
October 6, 2019
Sponsor
Russian Society of Colorectal Surgeons
Collaborators
Meril Life Sciences Pvt. Ltd., I.M. Sechenov First Moscow State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03910699
Brief Title
THREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer
Acronym
THREESTAPLER
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Russian Society of Colorectal Surgeons
Collaborators
Meril Life Sciences Pvt. Ltd., I.M. Sechenov First Moscow State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Leak, Anastomotic Haemorrhage, Anastomotic Complication, Rectal Neoplasms, Staple Misfire, Anastomosis, Anastomotic Stenosis
Keywords
Anastomosis, Anastomotic leakage, Rectal cancer, Total mesorectal excision, Low anterior resection, Anastomotic leak, Colorectal anastomosis, Three-row stapler
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Two-row anastomosis
Arm Type
Active Comparator
Arm Description
Colorectal anastomosis is created with a two-row circular surgical stapler
Arm Title
Three-row anastomosis
Arm Type
Experimental
Arm Description
Colorectal anastomosis is created with a three-row circular surgical stapler
Intervention Type
Device
Intervention Name(s)
Three-row circular stapler
Other Intervention Name(s)
MirusTM Disposable Circular Stapler 3 Row 29 (MCS-29R3)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Two-row circular stapler
Other Intervention Name(s)
Ethicon 29mm Curved Intraluminal Stapler (CDH29A)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anastomotic leakage rate
Description
The rate of colorectal anastomosis dehiscence documented with an X-ray and/or CT scan
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Operating time
Description
The duration of surgical procedure in minutes
Time Frame
1 day
Title
Circular stapler misfunction rate
Description
The rate of circular stapler inability to create a colorectal anastomosis in a way declared by the manufacturer
Time Frame
1 day
Title
Anastomotic bleeding rate
Description
The rate of bleeding from the line of stapled anastomosis verified by proctoscopy
Time Frame
30 days
Title
Re-intervention rate
Description
The rate of repeat surgeries due to anastomotic leakage
Time Frame
6 weeks
Title
Early postoperative complications rate
Description
The rate of complications in first 30 days after surgery
Time Frame
30 days
Title
The postoperative hospital stay
Description
The number of days from the first day after operation to discharge
Time Frame
1 month
Title
Complications of defunctioning stoma
Description
The rate of complications related to defunctioning stoma
Time Frame
3 months
Title
Overall quality of life
Description
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
Time Frame
7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery
Title
Cancer-related quality of life
Description
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.
Time Frame
7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery
Title
Manifestation of Low Anterior Resection Syndrome (LARS)
Description
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)
Time Frame
7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery
Title
Adverse events rate
Description
The rate of adverse events related to circular stapler usage
Time Frame
12 months
Title
Serious adverse events rate
Description
The rate of serious adverse events related to circular stapler usage
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Inna Tulina, MD
Phone
+7 (926) 408-66-72
Email
tulina@kkmx.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Nikita Nekliudov
Phone
+7 (915) 221-33-23
Email
neklyudov@kkmx.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petr Tsarkov, MD
Organizational Affiliation
Russian Society of Colorectal Surgeons
Official's Role
Study Director
Facility Information:
Facility Name
Clinic of Colorectal and Minimally Invasive Surgery - I.M. Sechenov First Moscow State Medical University
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikita Neklyudov, MD
Phone
+7-915-221-33-23
Email
neklyudov@kkmx.ru
12. IPD Sharing Statement
Citations:
PubMed Identifier
31192938
Citation
Nekliudov 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.
Results Reference
derived
Learn more about this trial
THREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer
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