Tags

Type your tag names separated by a space and hit enter

Primary anastomosis vs nonrestorative resection for perforated diverticulitis with peritonitis: a prematurely terminated randomized controlled trial.
Colorectal Dis. 2012 Nov; 14(11):1403-10.CD

Abstract

AIM

This randomized controlled trial (RCT) was performed to test the hypothesis that adverse event rates following primary anastomosis (PRA) are not inferior to those following nonrestorative colon resection for perforated diverticulitis with peritonitis.

METHOD

Patients admitted for perforated diverticulitis with peritonitis were randomly assigned to PRA (left colon resection with PRA and loop ileostomy) or nonrestorative colon resection (left colon resection with end colostomy). The endpoint was adverse events defined as mortality and morbidity following PRA or nonrestorative colon resection and stoma reversal. The estimated sample size was 300 patients in each study arm (alpha 0.10; 90% power).

RESULTS

During a 9-year period, 90 patients were randomly assigned to undergo PRA or nonrestorative colon resection in 14 centres in eight countries. Thirty-four PRA patients were comparable to 56 nonrestorative colon resection patients for age (P = 0.481), gender (P = 0.190), APACHE III (P = 0.281), Hinchey stage III vs IV (P = 0.394) and Mannheim Peritonitis Index (P = 0.145). There were no differences in operating time (P = 0.231), surgeries performed at night (P = 0.083), open vs laparoscopic approach (P = 0.419) and litres of peritoneal irrigation (P = 0.096). There was no significant difference in mortality (2.9 vs 10.7%; P = 0.247) and morbidity (35.3 vs 46.4%; P = 0.38) following PRA or nonrestorative colon resection. After a similar lag time (P = 0.43), 64.7% of PRA patients and 60% of nonrestorative colon resection patients underwent stoma reversal (P = 0.659). Adverse event rates following stoma reversal differed significantly after PRA and reversal of nonrestorative resection (4.5 vs 23.5%; P = 0.0589).

CONCLUSION

No conclusions may be drawn on preference of one treatment over another from this RCT because it was prematurely terminated following accrual of 15% of its sample size.

Authors+Show Affiliations

Division of General Surgery, Galliera Hospital, Genoa, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

22672447

Citation

Binda, G A., et al. "Primary Anastomosis Vs Nonrestorative Resection for Perforated Diverticulitis With Peritonitis: a Prematurely Terminated Randomized Controlled Trial." Colorectal Disease : the Official Journal of the Association of Coloproctology of Great Britain and Ireland, vol. 14, no. 11, 2012, pp. 1403-10.
Binda GA, Karas JR, Serventi A, et al. Primary anastomosis vs nonrestorative resection for perforated diverticulitis with peritonitis: a prematurely terminated randomized controlled trial. Colorectal Dis. 2012;14(11):1403-10.
Binda, G. A., Karas, J. R., Serventi, A., Sokmen, S., Amato, A., Hydo, L., & Bergamaschi, R. (2012). Primary anastomosis vs nonrestorative resection for perforated diverticulitis with peritonitis: a prematurely terminated randomized controlled trial. Colorectal Disease : the Official Journal of the Association of Coloproctology of Great Britain and Ireland, 14(11), 1403-10. https://doi.org/10.1111/j.1463-1318.2012.03117.x
Binda GA, et al. Primary Anastomosis Vs Nonrestorative Resection for Perforated Diverticulitis With Peritonitis: a Prematurely Terminated Randomized Controlled Trial. Colorectal Dis. 2012;14(11):1403-10. PubMed PMID: 22672447.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Primary anastomosis vs nonrestorative resection for perforated diverticulitis with peritonitis: a prematurely terminated randomized controlled trial. AU - Binda,G A, AU - Karas,J R, AU - Serventi,A, AU - Sokmen,S, AU - Amato,A, AU - Hydo,L, AU - Bergamaschi,R, AU - ,, PY - 2012/6/8/entrez PY - 2012/6/8/pubmed PY - 2013/3/21/medline SP - 1403 EP - 10 JF - Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland JO - Colorectal Dis VL - 14 IS - 11 N2 - AIM: This randomized controlled trial (RCT) was performed to test the hypothesis that adverse event rates following primary anastomosis (PRA) are not inferior to those following nonrestorative colon resection for perforated diverticulitis with peritonitis. METHOD: Patients admitted for perforated diverticulitis with peritonitis were randomly assigned to PRA (left colon resection with PRA and loop ileostomy) or nonrestorative colon resection (left colon resection with end colostomy). The endpoint was adverse events defined as mortality and morbidity following PRA or nonrestorative colon resection and stoma reversal. The estimated sample size was 300 patients in each study arm (alpha 0.10; 90% power). RESULTS: During a 9-year period, 90 patients were randomly assigned to undergo PRA or nonrestorative colon resection in 14 centres in eight countries. Thirty-four PRA patients were comparable to 56 nonrestorative colon resection patients for age (P = 0.481), gender (P = 0.190), APACHE III (P = 0.281), Hinchey stage III vs IV (P = 0.394) and Mannheim Peritonitis Index (P = 0.145). There were no differences in operating time (P = 0.231), surgeries performed at night (P = 0.083), open vs laparoscopic approach (P = 0.419) and litres of peritoneal irrigation (P = 0.096). There was no significant difference in mortality (2.9 vs 10.7%; P = 0.247) and morbidity (35.3 vs 46.4%; P = 0.38) following PRA or nonrestorative colon resection. After a similar lag time (P = 0.43), 64.7% of PRA patients and 60% of nonrestorative colon resection patients underwent stoma reversal (P = 0.659). Adverse event rates following stoma reversal differed significantly after PRA and reversal of nonrestorative resection (4.5 vs 23.5%; P = 0.0589). CONCLUSION: No conclusions may be drawn on preference of one treatment over another from this RCT because it was prematurely terminated following accrual of 15% of its sample size. SN - 1463-1318 UR - https://www.unboundmedicine.com/medline/citation/22672447/Primary_anastomosis_vs_nonrestorative_resection_for_perforated_diverticulitis_with_peritonitis:_a_prematurely_terminated_randomized_controlled_trial_ L2 - https://doi.org/10.1111/j.1463-1318.2012.03117.x DB - PRIME DP - Unbound Medicine ER -