Data will be collected at the baseline (before surgery), during the hospital stay, at 30 days, and at 6, 12, and 36 months after surgery (Table 1). The primary outcome of this study is the incidence of incisional hernias, including both symptomatic and radiologic hernias, at 12 months after surgery. Incisional hernia is assessed by interviewing patients regarding subjective symptoms, performing a physical examination of the abdomen, and reviewing abdominal-pelvic computed tomography (CT) scans. An incisional hernia is defined as either a symptomatic hernia during the interview or a radiologic hernia when it is diagnosed on both an abdominal-pelvic CT scan and a physical examination in cases where subjective symptoms do not exist. The secondary outcomes are the length of hospital stay, estimated blood loss, pain numerical rating scale (0: no; 10: worst pain imaginable) score on postoperative days 1, 2, and 3; reoperation, open conversion, 30-day postoperative complications, (as classified by the Clavien–Dindo classification) [9 (link)], surgical site infection (as classified by the Center for Disease Control and Prevention criteria [10 (link)] and ASEPSIS score [11 (link)]), 30-day mortality, the incidence of repair of incisional hernias, pathologic result of colon cancer (pathologic stage, histologic type, differentiation, number of harvested and metastatic regional lymph nodes, lymphovascular, venous, and perineural invasion, and distant metastasis), and patient-reported outcomes (short form-12 health survey questionnaire before surgery, and at 12 months after surgery and Body Image Questionnaire at 12 months after surgery) [12 (link), 13 (link)]. The incidence of incisional hernia at 36 months after surgery is another secondary outcome that will be separately analysed and reported after the last patient enrolled completes the follow-up.
Schedule for assessment, interventions, and follow-up
Time point(visit number)
BaselineV0
OperationV1
1 monthV2
6 monthsV3
12 monthsV4
36 monthsV5
Assessment
Eligibility assessment
Consent
X
Demographics
Baseline data
X
Colonoscopy
*
Operative outcomes
X
30-day morbidity
X
X
30-day mortality
X
X
Symptomatic hernia
X
X
X
X
Radiologic hernia
X
X
X
Pathologic report
*
Adjuvant chemotherapy
*
Body image questionnaire
X
SF-12
X
X
Assessments undertaken as routine care for colon cancer are displayed with an asterisk
Park S.Y., Ha G.W., Lee S.Y., Kim C.H, & Son G.M. (2023). Impact of non-muscle cutting periumbilical transverse incision on the risk of incisional hernia as compared to midline incision during laparoscopic colon cancer surgery: a study protocol for a multi-centre randomised controlled trial. Trials, 24, 152.
Other organizations :
Kyungpook National University Hospital, Chonbuk National University Hospital, Jeonbuk National University, Chonnam National University Hwasun Hospital, Pusan National University Yangsan Hospital
Surgical site infection (Center for Disease Control and Prevention criteria, ASEPSIS score)
30-day mortality
Incidence of repair of incisional hernias
Pathologic result of colon cancer (pathologic stage, histologic type, differentiation, number of harvested and metastatic regional lymph nodes, lymphovascular, venous, and perineural invasion, and distant metastasis)
Patient-reported outcomes (short form-12 health survey questionnaire, Body Image Questionnaire)
control variables
Baseline data (before surgery)
Colonoscopy
Pathologic report
Adjuvant chemotherapy
Annotations
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