Results
stoma, Stoma, tumour, ileus
INTESTINAL OBSTRUCTION, POSTOPERATIVE COMPLICATIONS, COMPLICATION, TUMOUR, COMPLICATIONS, ILEUS
Among a total of 257 eligible and consecutive patients, 214 patients were randomized: 107 patients to early stoma reversal and 107 to late reversal. A total of 68 patients were excluded: abdomino-perienal rectum excision (29), no stoma formation (28), withdrawal of consent (3), Hartmann’s procedure (2) and others (6). Thus, a total of 77 patients in the early reversal group and 69 patients in the late reversal group completed the study (Fig. CONSORT flow diagram for enrolment, allocation and follow-up.Demographic and clinical characteristics of the included patients who underwent early or late reversal of a diverting loop ileostomy after low anterior resection.BMI, Body mass index; ASA, American Society of Anesthesiologists; pT, Pathological tumour stage; pN, Pathological lymph node stage; cM, Clinical metastatic stage; Ta-TME, Transanal total mesorectal excision. *Maximal recommended limits of alcohol intake (units per week): males = 14 and females = 7 (Danish Health Authorities).In the group randomized to early stoma reversal, only 53 patients (69%) received the intended treatment. Stoma reversal was postponed by 3 months in 20 patients due to AL (17 patients), stoma complications with intestinal obstruction (2 patients), and other reasons (1 patient). Four patients did not have stoma reversal. Of these, two died on postoperative Days 6 and 12 due to complications of AL, and another 2 ended up with diverting loop ileostomy as a permanent stoma for other reasons.In the late reversal group, 60 patients (87%) received the intended treatment. Eight patients underwent earlier reversal due to ileus in seven and for an unknown reason in one. One patient ended up with diverting loop ileostomy as a permanent stomaThe total CCI (surgical + medical) within 30 days after stoma reversal in the early and late reversal groups was 7.58 and 6.66, respectively (Severity and type of postoperative complications in the two groups. A patient may have more than one complication.The mean time from LAR to stoma reversal was 47 and 154 days in the early and late reversal groups, respectively (Fate of the loop ileostomy, time to stoma reversal and surgical procedure at reversal in the two groups.€, missing data; 4 in the early group and 1 in the late group; CI, 95% Confidence Interval.The overall mean DET score was higher in the late reversal group (0.63; 95% CI 0.08, 1.17; No significant difference in quality of life was found at the 6- and 12-month follow-ups after LAR (Table Quality of life at baseline and at 6 and 12 months after low anterior resection.SD, standard deviation.