Аннотация:
Background:Colorectal anastomotic leakage (AL) is one of the most serious complications in rectal cancer surgery due to its negative impact on the overall as well as cancer-specific survival. Two-row stapling technique has become standard in low anterior resections (LARs), but has neither alleviated the morbidity, nor reduced the incidence of AL. This is the 1st study that aims to compare the success rate of new 3-row circular staplers compared to that of conventional 2-row staplers in a prospective, randomized clinical trial.Methods:The THREESTAPLER trial (Clinical Trials NCT03910699) is a prospective, noninferiority, 2-armed, parallel-group, patient and outcomes assessor blinded study with a 1:1 allocation ratio. Colorectal anastomosis will be formed using Ethicon 29mm Curved Intraluminal Stapler (CDH29A) in the active comparator group, and using Mirus Disposable Circular Stapler 3 Row 29 (MCS-29R3) in the experimental group. The hypothesis states that the incidence of AL in the 3-ro
Ключевые слова:
anastomotic leakage; colorectal anastomosis; colorectal neoplasms; low anterior resection; rectal cancer; stapled anastomosis; surgical stapling
anastomosis leakage; anastomotic bleeding; Article; cancer specific survival; cancer surgery; clinical article; clinical outcome; colorectal anastomosis; controlled study; device failure; device safety; disease course; disease severity; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; feces incontinence; female; human; laparoscopic surgery; male; operation duration; overall survival; parallel design; postoperative complication; postoperative period; preoperative care; priority journal; quality of life; randomized controlled trial; rectum anterior resection; rectum carcinoma; Short Form 36; single blind procedure; surgical margin; surgical patient; surgical stapling; anastomosis; anastomosis leakage; colorectal tumor; comparative study; devices; health care quality; incidence; postoperative complication; procedures; prospective study; psychology; stapler; surgical stapling; survival analysis; treatment outcome; Anastomosis, Surgical; Anas
Nekliudov N. A.
Tsar`kov P. V. Petr Vladimirovich 1957-
Tulina I. A. Inna Andreevna 1984-
Неклиудов Н. А.
Царьков П. В. Петр Владимирович 1957-
Тулина И. А. Инна Андреевна 1984-
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
Uni-center, patient-blinded, randomized, 12-month, parallel group, noninferiority study to compare outcomes of 3-row vs 2-row circular staplers for...
Текст визуальный непосредственный
Medicine (Baltimore)
Lippincott Williams & Wilkins
Vol.98, Issue24 Num.e15978
2019
Статья
anastomotic leakage colorectal anastomosis colorectal neoplasms low anterior resection rectal cancer stapled anastomosis surgical stapling
anastomosis leakage anastomotic bleeding Article cancer specific survival cancer surgery clinical article clinical outcome colorectal anastomosis controlled study device failure device safety disease course disease severity European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 feces incontinence female human laparoscopic surgery male operation duration overall survival parallel design postoperative complication postoperative period preoperative care priority journal quality of life randomized controlled trial rectum anterior resection rectum carcinoma Short Form 36 single blind procedure surgical margin surgical patient surgical stapling anastomosis anastomosis leakage colorectal tumor comparative study devices health care quality incidence postoperative complication procedures prospective study psychology stapler surgical stapling survival analysis treatment outcome Anastomosis, Surgical Anas
Background:Colorectal anastomotic leakage (AL) is one of the most serious complications in rectal cancer surgery due to its negative impact on the overall as well as cancer-specific survival. Two-row stapling technique has become standard in low anterior resections (LARs), but has neither alleviated the morbidity, nor reduced the incidence of AL. This is the 1st study that aims to compare the success rate of new 3-row circular staplers compared to that of conventional 2-row staplers in a prospective, randomized clinical trial.Methods:The THREESTAPLER trial (Clinical Trials NCT03910699) is a prospective, noninferiority, 2-armed, parallel-group, patient and outcomes assessor blinded study with a 1:1 allocation ratio. Colorectal anastomosis will be formed using Ethicon 29mm Curved Intraluminal Stapler (CDH29A) in the active comparator group, and using Mirus Disposable Circular Stapler 3 Row 29 (MCS-29R3) in the experimental group. The hypothesis states that the incidence of AL in the 3-ro