THREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer

Rectal Neoplasms Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03910699
• Other study ID #: RSCS-Z0836
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2019
• Source: Russian Society of Colorectal Surgeons
• Contact: Inna Tulina, MD
• Phone: +7 (926) 408-66-72
• Email: tulina[@]kkmx.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anastomosis
• Anastomotic Complication
• Anastomotic Haemorrhage
• Anastomotic Leak
• Anastomotic Stenosis
• Hemorrhage
• Rectal Neoplasms
• Staple Misfire

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	Clinic of Colorectal and Minimally Invasive Surgery - I.M. Sechenov First Moscow State Medical University	Moscow

Sponsors (3)

Lead Sponsor	Collaborator
Russian Society of Colorectal Surgeons	I.M. Sechenov First Moscow State Medical University, Meril Life Sciences Pvt. Ltd.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic leakage rate	The rate of colorectal anastomosis dehiscence documented with an X-ray and/or CT scan	6 weeks
Secondary	Operating time	The duration of surgical procedure in minutes	1 day
Secondary	Circular stapler misfunction rate	The rate of circular stapler inability to create a colorectal anastomosis in a way declared by the manufacturer	1 day
Secondary	Anastomotic bleeding rate	The rate of bleeding from the line of stapled anastomosis verified by proctoscopy	30 days
Secondary	Re-intervention rate	The rate of repeat surgeries due to anastomotic leakage	6 weeks
Secondary	Early postoperative complications rate	The rate of complications in first 30 days after surgery	30 days
Secondary	The postoperative hospital stay	The number of days from the first day after operation to discharge	1 month
Secondary	Complications of defunctioning stoma	The rate of complications related to defunctioning stoma	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events rate	The rate of adverse events related to circular stapler usage	12 months
Secondary	Serious adverse events rate	The rate of serious adverse events related to circular stapler usage	12 months