THREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer
THREESTAPLER
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
1 other identifier
interventional
154
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2019
CompletedFirst Posted
Study publicly available on registry
April 10, 2019
CompletedStudy Start
First participant enrolled
April 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedOctober 8, 2019
October 1, 2019
6 months
April 8, 2019
October 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anastomotic leakage rate
The rate of colorectal anastomosis dehiscence documented with an X-ray and/or CT scan
6 weeks
Secondary Outcomes (12)
Operating time
1 day
Circular stapler misfunction rate
1 day
Anastomotic bleeding rate
30 days
Re-intervention rate
6 weeks
Early postoperative complications rate
30 days
- +7 more secondary outcomes
Study Arms (2)
Two-row anastomosis
ACTIVE COMPARATORColorectal anastomosis is created with a two-row circular surgical stapler
Three-row anastomosis
EXPERIMENTALColorectal anastomosis is created with a three-row circular surgical stapler
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- Patient lost for observation
- Inability to complete all the trial procedures
- Death due to causes unrelated to anastomotic leak in early postoperative period
- \. Current smoker or tobacco use within \<specify timeframe\> 9. Patient wants to withdraw from the clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic of Colorectal and Minimally Invasive Surgery - I.M. Sechenov First Moscow State Medical University
Moscow, 119435, Russia
Related Publications (1)
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.
PMID: 31192938DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Petr Tsarkov, MD
Russian Society of Colorectal Surgeons
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Oncologic Colorectal Surgery Department, Clinic of Colorectal and Minimally Invasive Surgery
Study Record Dates
First Submitted
April 8, 2019
First Posted
April 10, 2019
Study Start
April 10, 2019
Primary Completion
October 1, 2019
Study Completion
October 1, 2020
Last Updated
October 8, 2019
Record last verified: 2019-10