Clinical trial NCT03910699: THREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer
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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Russian Society of Colorectal Surgeons
Sponsor class: OTHER
Collaborators: name: Meril Life Sciences Pvt. Ltd.
name: I.M. Sechenov First Moscow State Medical University
First posted: 2019-04-10
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anastomotic leakage rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Operating time
timeFrame: 1 day
measure: Circular stapler misfunction rate
timeFrame: 1 day
measure: Anastomotic bleeding rate
timeFrame: 30 days
measure: Re-intervention rate
timeFrame: 6 weeks
measure: Early postoperative complications rate
timeFrame: 30 days
measure: The postoperative hospital stay
timeFrame: 1 month
measure: Complications of defunctioning stoma
timeFrame: 3 months
measure: Overall quality of life
timeFrame: 7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery
measure: Cancer-related quality of life
timeFrame: 7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery
measure: Manifestation of Low Anterior Resection Syndrome (LARS)
timeFrame: 7 days before surgery, 1 month, 3 months, 6 months and 12 months after surgery
measure: Adverse events rate
timeFrame: 12 months
measure: Serious adverse events rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Clinic of Colorectal and Minimally Invasive Surgery - I.M. Sechenov First Moscow State Medical University
Study officials:
affiliation: Russian Society of Colorectal Surgeons
name: Petr Tsarkov, MD
role: STUDY_DIRECTOR
References:
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.