Dataset Information

Standard of Care and Outcomes of Primary Laparotomy Versus Laparotomy in Patients with Prior Open Abdominal Surgery (ReLap Study; DRKS00013001).

ABSTRACT:

Background

Patients undergoing relaparotomy are generally underrepresented in trials, despite how common the procedure is in clinical practice. The aim of this trial was to determine standard of care and gain evidence of intra- and postoperative outcomes for patients undergoing relaparotomy compared to primary laparotomy.

Methods

In this single-center controlled clinical trial, adult patients scheduled for elective abdominal surgery via relaparotomy or primary laparotomy were consecutively screened for eligibility. The perioperative course was monitored prospectively in five study visits during hospital stay and one study visit 1 year after surgery. Intraoperative standards, short and long-term outcomes were statistically explored at a level of significance of 5%.

Results

A total of 131 patients with relaparotomy and 50 patients with primary laparotomy were analyzed. In the relaparotomy group, the access to the abdomen took longer (23.5 min vs. 8.8 min; p = < 0.001) and the peritoneal adhesion index was higher (10.8 vs. 0.4; p = < 0.001). Inadvertent enterotomies were more frequent in the relaparotomy group (relaparotomy 0.3 versus primary laparotomy: 0.0; p = 0.002). The overall comprehensive complication index and rates of surgical site infection and wound dehiscence with evisceration were not different between the two groups. At long-term follow-up, rates of incisional hernia did not differ (relaparotomy: n = 12/104 (11.5%); primary laparotomy: n = 7/35 (20.0%); p = 0.208).

Discussion

In this first prospective comparison of relaparotomy with primary laparotomy, inadvertent enterotomies were more frequent in the relaparotomy group. However, contrary to previous retrospective studies, the risk of complications and incisional hernias was not increased compared to primary laparotomy.

Trial registration

Deutsches Register Klinischer Studien ( www.germanctr.de ): DRKS00013001.

SUBMITTER: Tran DT

PROVIDER: S-EPMC8523469 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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Publications

Standard of Care and Outcomes of Primary Laparotomy Versus Laparotomy in Patients with Prior Open Abdominal Surgery (ReLap Study; DRKS00013001).

Tran Dinh Thien-An DT Klotz Rosa R Harnoss Julian C JC Heger Patrick P Ritter Alina S AS Doerr-Harim Colette C Knebel Phillip P Schneider Martin M Büchler Markus W MW Diener Markus K MK Probst Pascal P

Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract 20210128 10

<h4>Background</h4>Patients undergoing relaparotomy are generally underrepresented in trials, despite how common the procedure is in clinical practice. The aim of this trial was to determine standard of care and gain evidence of intra- and postoperative outcomes for patients undergoing relaparotomy compared to primary laparotomy.<h4>Methods</h4>In this single-center controlled clinical trial, adult patients scheduled for elective abdominal surgery via relaparotomy or primary laparotomy were cons ...[more]

PMID: 33511544

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Dataset Information

Standard of Care and Outcomes of Primary Laparotomy Versus Laparotomy in Patients with Prior Open Abdominal Surgery (ReLap Study; DRKS00013001).

Background

Methods

Results

Discussion

Trial registration

Publications

Standard of Care and Outcomes of Primary Laparotomy Versus Laparotomy in Patients with Prior Open Abdominal Surgery (ReLap Study; DRKS00013001).

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