Surgical complications | |
Postoperative ileus | Obstructive or paralytic symptoms after surgery with the need to suspend food intake and/or insert a gastric tube; this has to be confirmed radiologically (by abdominal sonography or plain abdominal X-ray or CT scan) |
Postoperative hemorrhage | Need for administration of two or more red cell concentrates within the first 24 h postoperatively or need for reoperation |
Surgical site infection | CDC definition[21] |
Intra-abdominal abscess | Intra-abdominal collection of purulent or infected fluid (confirmed by culture) confirmed by puncture or by surgical reintervention |
Anastomotic leakage | Grade A-C, Definition of grade according to International Study Group of Rectal Cancer 2010, diagnosed by CT scan with radiographic enema, endoscopy, drain secretion (stool) or reoperation |
Non-surgical complications | |
Thrombosis | Clinical evidence (for example, pain, swelling, warmth, erythema) of a leg or pelvic vein thrombosis confirmed by duplex sonography or CT angiography, which was not previously known |
Pulmonary embolism | Clinical (for example, tachycardia, dyspnea) and/or radiological evidence of pulmonary embolism confirmed by spiral CT or lung perfusion scintigram |
Postoperative pulmonary infection | At least three of the following: |
- temperature > 38°C | |
- purulent tracheal secretion | |
- leucocytes >12 or < 4.5 [10E9/L] | |
- elevated CRP | |
AND Evidence for pulmonary infection radiologically | |
Renal failure | Need for dialysis or hemofiltration |
Cerebral insult | Ischemic or non-ischemic cerebrovascular event with persistent paresis or paralysis without previous history confirmed by CT or MRT |
Myocardial infarction | Electrocardiogram (NSTEMI or STEMI) and enzyme (Troponin I) changes suggestive of myocardial infarction or needing admission to coronary care unit |
Serious adverse events | SAE occurring from the day of randomization until regular end of trial follow-up or withdrawal |
Mortality | All causes of mortality within 3 months after primary surgery |
Duration of surgical intervention | First incision to the completion of skin closure (resection rectopexy) or the last coloanal suture (Delorme’s procedure) |
Length of initial hospital stay | Means the hospitalization period from the primary operation date until the day of discharge (= postoperative hospital stay) |
Reoperation rate for recurrent prolapse | Any surgical intervention for a recurrence |
Cumulative hospital stay | Defined by the days in hospital after the primary surgery as well as the following hospitalizations due to complications or recurrence within 24 months after the primary operation |
Change of quality of life, constipation and incontinence | |
Measured by means of the appropriate questionnaires SF-12, ([22], validated in German), Herold constipation score ([23], evaluated in German, but not yet published), Wexner-Score ([10], non-validated in German, most commonly used score) and Rockwood-FIQLScore ([24], validated), prior to the surgical intervention as well as 6, 12, and 24 months after the intervention |