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

NCT03910699 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2019-10-08

No results posted yet for this study

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.

Conditions

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

Interventions

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.

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.

Sponsors & Collaborators

  • Meril Life Sciences Pvt. Ltd.

    collaborator INDUSTRY

  • I.M. Sechenov First Moscow State Medical University

    collaborator OTHER

  • Russian Society of Colorectal Surgeons

    lead OTHER

Principal Investigators

  • Petr Tsarkov, MD · Russian Society of Colorectal Surgeons

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2019-10-01
Completion
2020-10-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03910699 on ClinicalTrials.gov