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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03910699
Other study ID # RSCS-Z0836
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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