Anastomotic LeakTHREESTAPLERNCT03910699
THREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer
A study testing Three-row circular stapler and Two-row circular stapler in people with Anastomotic Leak and Anastomotic Haemorrhage, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anastomotic Leak, Anastomotic Haemorrhage, Anastomotic Complication
- What is being tested?
- Three-row circular stapler and Two-row circular stapler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteRussia
- Study dates
- 10 Apr 2019to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Clinic of Colorectal and Minimally Invasive Surgery - I.M. Sechenov First Moscow State Medical University
Moscow, 119435
Nikita Neklyudov, MD, +7-915-221-33-23, neklyudov@kkmx.ru
About this study
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
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.
Read the 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.
- Conditions
- Anastomotic Leak, Anastomotic Haemorrhage, Anastomotic Complication, Rectal Neoplasms, Staple Misfire, Anastomosis
- Being tested
- Three-row circular stapler, Two-row circular stapler
- Keywords
- Anastomosis, Anastomotic leakage, Rectal cancer, Total mesorectal excision, Low anterior resection, Anastomotic leak, Colorectal anastomosis, Three-row stapler
- Medical subject headings
- Anastomotic Leak, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-row circular staplerDevice
Also called MirusTM Disposable Circular Stapler 3 Row 29 (MCS-29R3)
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.
Two-row circular staplerDevice
Also called Ethicon 29mm Curved Intraluminal Stapler (CDH29A)
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.
| Study group | Role | What they receive |
|---|---|---|
| Two-row anastomosis | Active comparator | Colorectal anastomosis is created with a two-row circular surgical stapler Receives: Device: Two-row circular stapler |
| Three-row anastomosis | Experimental | Colorectal anastomosis is created with a three-row circular surgical stapler Receives: Device: Three-row circular stapler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leakage rate
The rate of colorectal anastomosis dehiscence documented with an X-ray and/or CT scan
Measured: 6 weeks
Secondary outcomes (12)
Operating time
The duration of surgical procedure in minutes
Measured: 1 day
Circular stapler misfunction rate
The rate of circular stapler inability to create a colorectal anastomosis in a way declared by the manufacturer
Measured: 1 day
Anastomotic bleeding rate
The rate of bleeding from the line of stapled anastomosis verified by proctoscopy
Measured: 30 days
Re-intervention rate
The rate of repeat surgeries due to anastomotic leakage
Measured: 6 weeks
Early postoperative complications rate
The rate of complications in first 30 days after surgery
Measured: 30 days
The postoperative hospital stay
The number of days from the first day after operation to discharge
Measured: 1 month
Complications of defunctioning stoma
The rate of complications related to defunctioning stoma
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 12 months
Serious adverse events rate
The rate of serious adverse events related to circular stapler usage
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start10 Apr 2019
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anastomotic LeakStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Society of Colorectal Surgeons
- Sponsor type
- University, hospital or other
- Collaborators
- Meril Life Sciences Pvt. Ltd., I.M. Sechenov First Moscow State Medical University
- Responsible party
- Principal investigator, Inna Tulina, I.M. Sechenov First Moscow State Medical University
- Investigators
- Petr Tsarkov, MD, Study director, Russian Society of Colorectal Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910699
- Sponsor's protocol ID
- RSCS-Z0836
- Acronym
- THREESTAPLER
- Status last verified
- Oct 2019
- First submitted
- 8 Apr 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tulina 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.
PubMed 42572962Nekliudov 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.
PubMed 31192938
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03910699
- Acronym / sponsor ID
- THREESTAPLER / RSCS-Z0836
- Conditions
- Anastomotic Leak, Anastomotic Haemorrhage, Anastomotic Complication, Rectal Neoplasms, Staple Misfire, Anastomosis
- Keywords
- Anastomosis, Anastomotic leakage, Rectal cancer, Total mesorectal excision, Low anterior resection, Anastomotic leak, Colorectal anastomosis, Three-row stapler
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Russian Society of Colorectal SurgeonsUniversity, hospital or other
- Collaborators
- Meril Life Sciences Pvt. Ltd., I.M. Sechenov First Moscow State Medical University
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two-row anastomosis | Active comparator | Device: Two-row circular staplerColorectal anastomosis is created with a two-row circular surgical stapler |
| Three-row anastomosis | Experimental | Device: Three-row circular staplerColorectal anastomosis is created with a three-row circular surgical stapler |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-row circular staplerAlso: MirusTM Disposable Circular Stapler 3 Row 29 (MCS-29R3)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. | Device | Three-row anastomosis |
| Two-row circular staplerAlso: Ethicon 29mm Curved Intraluminal Stapler (CDH29A)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. | Device | Two-row anastomosis |
Primary outcome
Anastomotic leakage rate
Time frame: 6 weeks
The rate of colorectal anastomosis dehiscence documented with an X-ray and/or CT scan
12 secondary outcomes
Operating time
Time frame: 1 day
Circular stapler misfunction rate
Time frame: 1 day
Anastomotic bleeding rate
Time frame: 30 days
Re-intervention rate
Time frame: 6 weeks
Early postoperative complications rate
Time frame: 30 days
The postoperative hospital stay
Time frame: 1 month
Complications of defunctioning stoma
Time frame: 3 months
Overall quality of life
Time frame: 7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery
Cancer-related quality of life
Time frame: 7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery
Manifestation of Low Anterior Resection Syndrome (LARS)
Time frame: 7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery
Adverse events rate
Time frame: 12 months
Serious adverse events rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Derived from this study: PubMed 42572962Tulina 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.
- Derived from this study: PubMed 31192938Nekliudov 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.
Related trials for Anastomotic Leak
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
RecruitingObservational study
Surgical Intuition in Anastomotic Leakage After Colorectal Surgery
Anastomotic Leaks
Recruiting
Perioperative Biomarkers in Colorectal and Gastric Cancer Surgery
Colorectal (Colon or Rectal) Cancer, STOMACH NEOPLASM
Not yet recruiting
Study of Eso-SPONGE for Treating Leaks After Upper Gastrointestinal Surgery
Anastomotic Leaks
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Tsarkov, MD study director
Russian Society of Colorectal Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-row circular stapler and Two-row circular stapler in people with Anastomotic Leak and Anastomotic Haemorrhage, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inna Tulina, MD (+7 (926) 408-66-72, tulina@kkmx.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leakage rate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03910699, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.