Introduction
Background and rationale
Objectives
Trial design
Methods/design
Study setting
Eligibility criteria
Inclusion criteria
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APR or low Hartmann’s procedure for rectal cancer with curative intent and permanent end colostomy, either by laparoscopic technique or robotic-assisted APR
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18 years of age or older
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Patient has a life expectancy of at least 12 months
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Patient signs the informed consent and agrees to attend all study visits
Exclusion criteria
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APR or Hartmann’s resection by laparotomy or conversion to laparotomy
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Complications requiring laparotomy during postoperative treatment on the surgical ward
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Patient with a comorbid illness or condition that would preclude surgical treatment (American Society of Anesthesiologists (ASA) 4–5)
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Patients with concurrent or previous malignant tumors within 5 years before study enrollment
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Patients with grade-T4b tumors that impose a multi-organ resection
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Rectal malignancy other than adenocarcinoma
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Patients undergoing emergency procedures
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Planned rectal surgery along with major concomitant procedures (e.g., hepatectomies, other intestinal resections)
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Metastatic disease with no possibility of curative surgery
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Pregnancy or suspected pregnancy
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Patients living geographically distant and/or unwilling to return for follow-ups or comply with all study requirements
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Active abdominal infection at the time of surgery
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Previous surgery at the colostomy site
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Language barrier or other reasons why informed consent is not possible
Interventions
Surgical technique
Outcomes
Schedule of events | Baseline | Procedure | Discharge | 30 days ±3 days | 1 year ±14 days | 3 years ±30 days | 5 years ±30 days | Unscheduled visit |
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Informed consent | X | |||||||
Demographics and medical history | X | |||||||
QoL (RAND-36) | X | X | X | X | X | |||
QoL (colostomy impact score) | X | X | X | X | ||||
Procedure details | X | |||||||
CT scan findings | X | X | ||||||
Protocol deviation | Xa | Xa | Xa | Xa | Xa | Xa | Xa | Xa |
Complications | Xa | Xa | Xa | Xa | Xa | Xa | Xa | |
Study closure form | Xb |
- PSH, either symptomatic or asymptomatic, detected by CT scan during 12 months’ follow-up
- Incidence of CT-detected PSH during 3-year follow-up
- Incidence of clinically detected PSH during 1-, 3-, and 5-year follow-ups
- PSH-operation-free survival at 3 and 5 years
- Surgical-site infection (SSI) rate
- Clavien-Dindo grade I–V complications at 30 days postoperatively
- Stoma-related complications and problems during long-term follow-up
- Stoma-related readmissions
- Reoperation rate
- Operative time
- Length of stay (LOS) in days
- Quality of life (RAND-36, colostomy impact score)
- Medico-economic sub-study including direct costs at hospital and indirect costs caused by sick leave
- Radiological sub-study including definition of abdominal wall measurements and location of stoma
Radiological sub-study
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Subcutaneous abdominal fat in centimeters on the contra-lateral side of the stoma
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Distance of the medial part of the stoma to midline (umbilicus as the midline definition)
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Area of the stoma aperture (2 cm width × height/2)
Pre-intervention data
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Age
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Sex
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ASA class
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Weight, height
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Other illnesses and medications
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Smoking history
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Previous hernias, either symptomatic or asymptomatic
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Neoadjuvant treatment
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Preoperative hemoglobin and carcinoembryonic antigen (CEA)
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Quality of life defined by the RAND-36
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Informed consent and patient information
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Randomization
Intervention data
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Antibiotic prophylaxis
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Operating time
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Resources used during the operation
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Total blood loss
Post-intervention data
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Length of postoperative ileus (POI) measured in days and defined by air in the stoma
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Re-operation rate
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Complications as defined by Clavien-Dindo classification
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Incidence of SSI as defined by the CDC
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Incidence of either clinically or radiologically detected PSHs
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Quality of life at each follow-up
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Problems and complications with stoma
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Tumor–nodes–metastases (TNM) score
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Hemoglobin and CEA at each control
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Oncological adjuvant treatment given