Идёт набор NCT04982653

Short Stitch Versus Traditional Suture for the Prevention of Incisional Hernia After Open Hepatectomy

Фаза II С лечением Liver and Intrahepatic Bile Duct Neoplasm Metastatic Malignant Neoplasm in the Liver Primary Malignant Liver Neoplasm

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Quality-of-Life Assessment, Surgical Procedure, Surgical Procedure.
Кому может быть актуально: Состояния в реестре: Liver and Intrahepatic Bile Duct Neoplasm, Metastatic Malignant Neoplasm in the Liver, Primary Malignant Liver Neoplasm. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Incisional Hernia Prevention After Open Hepatectomy by Small Tissue Bite Fascial Closure: A Randomized Clinical Trial

Обзор

This clinical trial compares two different kinds of surgical closing techniques, short stitch suture or traditional suture, in patients who are having liver tumor surgery. This study may help researchers learn if one technique can lower the chances of developing a hole in the wall of the abdomen (an abdominal hernia) at the incision site better than the other.

Подробное описание

PRIMARY OBJECTIVE:

I. To assess whether small bites abdominal wall closure reduces the risk of developing incisional hernia following liver surgery.

SECONDARY OBJECTIVES:

I. To compare short-term perioperative outcomes between small bites and typical fascial closure technique.

II. To assess the hernia incidence rate of short stich versus (vs.) standard closure in subgroups of patients with inverted-L or midline incisions.

III. To assess the hernia incidence rate of Kawaguchi-Gayet hepatectomy complexity classifications I/II vs. III (hernia rate by extent of hepatectomy).

IV. To assess the hernia incidence rate of preoperative chemotherapy or no preoperative chemotherapy (hernia rate by exposure to preoperative chemotherapy).

V. To assess impact of small bites abdominal wall closure on health care quality of life following liver surgery.

VI. To assess safety of small tissue bites fascial closure suture technique versus conventional fascial closure following hepatectomy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (INTERVENTION): Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.

ARM II (CONTROL): Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.

After completion of study, patients are followed up at 1-4 weeks, and then at 3, 6, and 12 months.

Вмешательства

Другое Quality-of-Life Assessment
Ancillary studies
Процедура Surgical Procedure
Undergo hepatectomy using small bites fascial method for abdominal wall closure
Процедура Surgical Procedure
Undergo hepatectomy using conventional fascial method for abdominal wall closure

Первичные конечные точки

Radiographic incidence rate of incisional hernia [Срок оценки: Up to 12 months after surgery]

Вторичные конечные точки (10)

Surgical site infection [Срок оценки: Up to 90 days after surgery]
Surgical site occurrence [Срок оценки: Up to 90 days after surgery]
Surgical site occurrence requiring procedural intervention [Срок оценки: Up to 90 days after surgery]
Postoperative complications [Срок оценки: Up to 90 days after surgery]
Need for reoperation [Срок оценки: Up to 90 days after surgery]
Need for reoperation secondary to complication of abdominal closure [Срок оценки: Up to 90 days after surgery]
Length of hospital stay (postoperatively) [Срок оценки: Up to 90 days after surgery]
Any readmission related to hernia repair [Срок оценки: Up to 30 days after surgery]
Health-related quality of life assessment [Срок оценки: Up to 12 months after surgery]
Incidence of adverse events (AEs) [Срок оценки: Up to 90 days after surgery]

Критерии участия

Критерии включения

Patients undergoing hepatectomy for malignant diagnosis (primary or secondary) from 5/1/2021 through 11/1/2024 will be eligible for inclusion in this study
Elective surgery
Age >= 18
Planned midline laparotomy incision or inverted-L incision