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Cola

Colorectal anastomosis is created with a two-row circular surgical stapler

Colorectal anastomosis is created with a three-row circular surgical 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.

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 two-row circular stapler, defunctioning colostomy is performed.

Two-row circular stapler

Inna Tulina, MD

Nikita Nekliudov

Nikita Neklyudov, MD

Petr Tsarkov, MD

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.

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.

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

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

The rate of colorectal anastomosis dehiscence documented with an X-ray and/or CT scan

The duration of surgical procedure in minutes

The rate of circular stapler inability to create a colorectal anastomosis in a way declared by the manufacturer

The rate of bleeding from the line of stapled anastomosis verified by proctoscopy

The rate of repeat surgeries due to anastomotic leakage

The rate of complications in first 30 days after surgery

The number of days from the first day after operation to discharge

The rate of complications related to defunctioning stoma

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

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.

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)

The rate of adverse events related to circular stapler usage

The rate of serious adverse events related to circular stapler usage

Meril Life Sciences Pvt. Ltd.

I.M. Sechenov First Moscow State Medical University

Russian Society of Colorectal Surgeons

Head of Oncologic Colorectal Surgery Department, Clinic of Colorectal and Minimally Invasive Surgery

Low anterior resection with TME plus anastomotic transanal reinforcement without protective ileostomy/colostomy (transanal anastomotic reinforced arm:TAR-LAR)

Standard low anterior resection with TME plus protective ileostomy/colostomy (S-LAR)

a circular anal dilator (CAD) of 34mm in diameter will be introduced into the anus to facilitate the transanal introduction of the 29-31 circular stapler. The stapler shaft will be introduced trying to avoid the stapler line and connected with the anvil of the prepared proximal colon and then fired.

Patients selected on the TAR-LAR arm will have the stapled suture reinforced by 6 supplemental full thickness stitches in vycril 3/0 placed transanally with the aid of a semicircular valve introduced into the CAD (Epo Flier, SapiMed SPA, Alessandria, Italy), at hours 2-4-6-8-10-12.

transanal anastomotic reinforcement

S-LAR patients will had a standard lateral protective ileostomy in the right iliac region or a colostomy in the left region.

protective ileostomy group

Epo Flier, SapiMed SPA, Alessandria, Italy

a circular anal dilator (CAD)

Donato F Altomare, MD

Maria Di Lena, MD

Arcangelo Picciariello, MD

Anastomotic leak after low rectal cancer surgery occurs between 3 and 24% of the cases and is a severe complication leading to sepsis, permanent colostomy, higher risk of local cancer recurrence and eventually death. In order to prevent this complication a protecting diverting stoma is usually fashioned with consequent morbidity due to the stoma and its closure and severe impact on patients' quality of life. This prospective, multi-center, parallel-arm, randomized controlled equivalence trial is aimed to demonstrate whether a transanal reinforcement of the suture line can prevent anastomotic leakage after low rectal cancer surgery thus avoiding the need for a covering ileostomy

Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery

Multicenter Randomized Controlled Trial of Transanal Reinforcement of Low Rectal Anastomosis Versus Protective Ileostomy in the Prevention of Anastomotic Leak After Rectal Cancer Surgery

anastomoltic leak will be checked by barium enema after 30 days from the low rectal anastomosis

the duration in minutes of the two types of operation

Donato F Altomare

Associate professor

the anastomotic reinforcement with nebulized cyanoacrylate glue using the special short catheter device for open surgery or the laparoscopic catheter.

No reinforcement will be applied on the anastomosis line

Anastomosis Reinforcement with with nebulization of 1cc of glue on the anastomosis line

Cyanoacrylate reinforcement

No reinforcement

Donato Altomare, MD

Donato F Altomare, Prof

Donato Altomare, Prof

The problem of anastomotic leak is particularly relevant in rectal surgery. Many risk factors have been recognized in the onset of this complication. Preventing the anastomotic leak can bring benefits to the patient and the health system.

Several attempts have been proposed to reduce the risk of anastomotic leakage in rectal cancer surgery including suture protection with omental flap and external suture reinforcement by biological glue or mesh.

Cyanoacrylate (Glubran 2®) is a synthetic glue with sealing, adhesive and hemostatic properties widely used in surgery. The sealing effect creates an antiseptic barrier against bacteria.

The hypothesis is that the application of nebulized cyanoacrylate to the colo-rectal anastomosis in open or laparoscopic/robotic rectal surgery can prevent the leakage

Colorectal cancer (CRC) is the second most common cause of cancer-related death in male and the third in females in Western Countries accounting for more than 500,000 deaths in 2013 worldwide.

One of the most worrying postoperative complication in colorectal surgery is the anastomotic leak which can occur in about 10-15% of the cases.

This complication severely impact clinical outcomes with increased risk of death or permanent stoma, higher risk of local recurrence) and relevant increase in hospital costs (length of hospital stay, admission to intensive care, re-interventions).

The problem of anastomotic leak is particularly relevant in rectal surgery. The more distal the anastomosis, the higher the likelihood of failure, with resection of a distal rectal cancer having almost a five-fold increased risk of anastomotic leak compared with resection for colon cancer.

In fact, anastomotic Leakage (AL) is the most severe complication after Low anterior resection of rectum for cancer, occurring between 3 and 24 % of patients.

Many risk factors have been recognized in the onset of this complication, including gender (male patient have a higher anastomotic leak rate), malnutrition, obesity an diabet, american society anesthesiologists (ASA) score, tobacco use, cardiovascular disease, immunosuppression, use of NSAID, preoperative pelvis radiation.

Other intraoperative risk factors considered are the splenic flexure mobilization with proximal ligation of the inferior mesenteric artery (IMA), positive intraoperative Air-Leak Test and the perfusion of the anastomosis.

Temporary fecal diversion has also been suggested (although a diverting stoma mitigates the clinical consequences of an anastomotic leak but does not prevent it.

Other intraoperative technical factors include the use of single or double stapled anastomotic techniques, with or without transanal reinforcing sutures.

Therefore, preventing the anastomotic leak can bring benefits to the patient and the health system.

All the risk factors described above represent the rationale that justifies the use of intraoperative procedures to prevent the anastomotic leak, such as additional manual stiches to the mechanical suture and / or patches of collagen (proper reinforcement or buttressing) or of sealants.

Several attempts have been proposed to reduce the risk of AL in rectal cancer surgery including suture protection with omental flap and external suture reinforcement by biological glue or mesh.

Some Authors have reported good results of reinforcement of the colon anastomosis with cyanoacrylate glue. in a porcine model.

Cyanoacrylate is a synthetic glue with sealing, adhesive and haemostatic properties widely used in surgery. Furthermore the sealing effect creates an antiseptic barrier against bacteria.

Several clinical studies have described the utility of cyanoacrylate glue mainly in vascular surgery, urology and bariatric surgery.

Considering its mechanical, physical, biological properties and its safety, cyanoacrylate glue could facilitate the healing of the colorectal anastomosis reducing leak rate, without negative effects on perfusion.

The hypothesis is that the application of nebulized cyanoacrylate to the colo-rectal anastomosis in open or laparoscopic/robotic rectal surgery can prevent the leakage

ReAL Trial (Rectal Anastomotic seaL)

Prevention of Anastomotic Leak in Colorectal Surgery by Glue Reinforcement. A Prospective Randomized Trial.

leakage of the colorectal anastomosis clinically proven or with two sides X-ray

the amount of bleeding during the operation

purulent discharge from the wound with positive culture

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
THREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer	NCT03910699	Anastomotic Lea... Anastomotic Hae... Anastomotic Com... Rectal Neoplasm... Staple Misfire Anastomosis Anastomotic Ste...	Three-row circu... Two-row circula...	18 Years - 85 Years	Russian Society of Colorectal Surgeons
Transanal Reinforcement of Low Rectal Anastomosis in Rectal Cancer Surgery	NCT02279771	Rectal Cancer	transanal anast... protective ileo... a circular anal...	30 Years - 80 Years	Societa Italiana di Chirurgia ColoRettale
ReAL Trial (Rectal Anastomotic seaL)	NCT03941938	Rectal Cancer	Cyanoacrylate r... No reinforcemen...	18 Years - 85 Years	Societa Italiana di Chirurgia ColoRettale
ReAL Trial (Rectal Anastomotic seaL)	NCT03941938	Rectal Cancer	Cyanoacrylate r... No reinforcemen...	18 Years - 85 Years	Societa Italiana di Chirurgia ColoRettale

Spots Global Cancer Trial Database for colorectal anastomosis