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

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.

Study Overview

• Status: Unknown
• Conditions: Rectal Neoplasms; Anastomotic Leak; Anastomotic Stenosis; Anastomotic Complication; Anastomosis; Anastomotic Haemorrhage; Staple Misfire
• Intervention / Treatment: Device: Two-row circular stapler; Device: Three-row 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 Type: Interventional
• Enrollment (Anticipated): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119435
    • Recruiting
    • Clinic of Colorectal and Minimally Invasive Surgery - I.M. Sechenov First Moscow State Medical University
    • Contact: Nikita Neklyudov, MD; Phone Number: +7-915-221-33-23; Email: neklyudov@kkmx.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Two-row anastomosis; Colorectal anastomosis is created with a two-row circular surgical stapler	Device: Two-row circular stapler; 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.; Other Names: Ethicon 29mm Curved Intraluminal Stapler (CDH29A)
Experimental: Three-row anastomosis; Colorectal anastomosis is created with a three-row circular surgical stapler	Device: Three-row circular stapler; 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.; Other Names: MirusTM Disposable Circular Stapler 3 Row 29 (MCS-29R3)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Russian Society of Colorectal Surgeons
• Collaborators: I.M. Sechenov First Moscow State Medical University; Meril Life Sciences Pvt. Ltd.
• Investigators: Study Director: Petr Tsarkov, MD, Russian Society of Colorectal Surgeons

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2019
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 6, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Rectal cancer; Anastomotic leakage; Anastomosis; Total mesorectal excision; Anastomotic leak; Low anterior resection; Colorectal anastomosis; Three-row stapler
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Hemorrhage; Rectal Neoplasms; Anastomotic Leak
• Other Study ID Numbers: RSCS-Z0836

Drug and device information, study documents

• 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