Table 1. Characteristics of included studies in the present systematic review.
First author | Year | Total No. of pts | N (stoma) | N (no stoma) | Type of operation | Confirmation of leak | Inclusion criteria | Randomization and allocation | Blinding |
---|---|---|---|---|---|---|---|---|---|
Graffner | 1983 | 50 | 25 | 25 | LAR | Clinical exam, gastrografin enema, proctorectoscopy at 3-month, double-contrast radiography at 1 year | Anastomosis below peritoneal reflection | Sealed envelope | Not possible |
Pakkastie | 1997 | 38 | 19 | 19 | LAR | Clinical exam, radiologic (rectal contrast, CT) | Anastomosis below peritoneal reflection | Sealed envelope | Not possible |
Pimentel | 2003 | 36 | 18 | 18 | LAR | Not reported | Anastomosis ≤4 cm from anal verge | Sealed envelope | Not possible |
Matthiessen | 2007 | 234 | 116 | 118 | LAR | Clinical (digital palpation, inspection of drain), endoscopic or radiologic (rectal contrast study, CT) diagnoses | Anastomosis ≤7 cm anal verge | Sealed envelope | Not possible |
Chude | 2008 | 256 | 136 | 120 | LAR | Clinical exam, radiologic (rectal contrast, CT) | Operable rectal cancer ≤5 cm from anal verge | Sealed envelope | Not possible |
Ulrich | 2009 | 34 | 18 | 16 | LAR | Septic profile, CT scan with rectal filling ± laparotomy | Operable rectal cancers low (4–9 cm) or middle (8–12 cm) from anal verge | Sealed envelope | Not possible |
Thoker | 2014 | 78 | 34 | 44 | LAR | Septic profile, US abdomen/pelvis, CT with oral contrast | Operable rectal cancer 4–12 cm from anal verge | “Systemic” random sampling | Not possible |
Mrak | 2016 | 166 | 94 | 72 | LAR | Clinical diagnoses, confirmed with gastrografin enema ± CT scan ± sigmoidoscopy | Distal border tumors <16 cm from anal verge on rigid rectoscopy | Internet-based randomization | Not possible |
LAR, low anterior resection; n, number.