SPONGE-assisted versus Trendelenburg position surgery in laparoscopic sigmoid and rectal cancer surgery (SPONGE trial): randomized clinical trial.
Journal
The British journal of surgery
ISSN: 1365-2168
Titre abrégé: Br J Surg
Pays: England
ID NLM: 0372553
Informations de publication
Date de publication:
14 10 2022
14 10 2022
Historique:
received:
05
04
2022
revised:
27
06
2022
accepted:
30
06
2022
pubmed:
2
8
2022
medline:
19
10
2022
entrez:
1
8
2022
Statut:
ppublish
Résumé
In minimally invasive surgery of the sigmoid colon and rectum a retractor sponge has been introduced as an alternative to the Trendelenburg position. This randomized clinical trial (RCT) compared postoperative duration of hospital stay and perioperative outcomes in patients with sigmoid or rectal cancer undergoing sponge-assisted versus Trendelenburg position surgery. The SPONGE trial is a single-centre RCT nested within the Dutch nationwide prospective observational cohort of patients with colorectal cancer, and follows the Trials within Cohorts (TwiCs) design. Patients with sigmoid or rectal cancer undergoing elective laparoscopic or robotic surgery were randomized to either sponge-assisted or Trendelenburg surgery on a 1:1 basis using block randomization. Duration of postoperative hospital stay was the primary outcome and was compared using the Mann-Whitney U test. Secondary endpoints included the proportion of complications, readmissions, or mortality versus the χ2 test in intention-to-treat and per-protocol analyses. This trial was not blinded for patients in the intervention arm or physicians. Between November 2015 and June 2021, 82 patients were randomized to sponge-assisted surgery and 81 to Trendelenburg surgery. After post-randomization exclusion, 150 patients remained for analyses (75 patients per arm). There was no statistically significant difference in median duration of hospital stay (5 days versus 4 days, respectively; P = 0.06), 30-day postoperative complications (30 per cent versus 31 per cent; P = 1.00), readmission rate (8 per cent versus 15 per cent; P = 0.30), or mortality (0 per cent versus 1 per cent, P = 1.00). The per-protocol analysis showed similar results. No adverse device events were seen. Sponge-assisted laparoscopic/robotic surgery does not reduce the duration of hospital stay, or perioperative morbidity or mortality. NCT02574013 (http://www.clinicaltrials.gov).
Sections du résumé
BACKGROUND
In minimally invasive surgery of the sigmoid colon and rectum a retractor sponge has been introduced as an alternative to the Trendelenburg position. This randomized clinical trial (RCT) compared postoperative duration of hospital stay and perioperative outcomes in patients with sigmoid or rectal cancer undergoing sponge-assisted versus Trendelenburg position surgery.
METHODS
The SPONGE trial is a single-centre RCT nested within the Dutch nationwide prospective observational cohort of patients with colorectal cancer, and follows the Trials within Cohorts (TwiCs) design. Patients with sigmoid or rectal cancer undergoing elective laparoscopic or robotic surgery were randomized to either sponge-assisted or Trendelenburg surgery on a 1:1 basis using block randomization. Duration of postoperative hospital stay was the primary outcome and was compared using the Mann-Whitney U test. Secondary endpoints included the proportion of complications, readmissions, or mortality versus the χ2 test in intention-to-treat and per-protocol analyses. This trial was not blinded for patients in the intervention arm or physicians.
RESULTS
Between November 2015 and June 2021, 82 patients were randomized to sponge-assisted surgery and 81 to Trendelenburg surgery. After post-randomization exclusion, 150 patients remained for analyses (75 patients per arm). There was no statistically significant difference in median duration of hospital stay (5 days versus 4 days, respectively; P = 0.06), 30-day postoperative complications (30 per cent versus 31 per cent; P = 1.00), readmission rate (8 per cent versus 15 per cent; P = 0.30), or mortality (0 per cent versus 1 per cent, P = 1.00). The per-protocol analysis showed similar results. No adverse device events were seen.
CONCLUSION
Sponge-assisted laparoscopic/robotic surgery does not reduce the duration of hospital stay, or perioperative morbidity or mortality.
TRIAL REGISTRATION
NCT02574013 (http://www.clinicaltrials.gov).
Identifiants
pubmed: 35909251
pii: 6652611
doi: 10.1093/bjs/znac249
doi:
Banques de données
ClinicalTrials.gov
['NCT02574013']
Types de publication
Journal Article
Observational Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1081-1086Informations de copyright
© The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.