Surgical endoscopy
September 25, 2026 · via Europe PMC
Parastomal hernia outcomes after sutured versus unsutured composite techniques for specimen-extraction-site loop ileostomy following laparoscopic low anterior resection: the UNSEAL randomized controlled trial.
Mao J, Xia P, Wang Y, An X, Dai Y, Zhang X.
AI summary — for doctors, generated from the abstract only
An unsutured composite technique for specimen-extraction-site loop ileostomy reduced parastomal hernia and stoma formation time compared with a sutured technique.
What was studied
The UNSEAL single-center open-label randomized trial of patients undergoing laparoscopic low anterior resection for rectal cancer, comparing sutured fascial/peritoneal fixation with an unsutured approach using a supporting rod and smaller tailored fascial aperture.
Key findings
- 216 of 233 randomized patients analyzed per protocol
- Parastomal hernia 13.5% sutured vs 4.8% unsutured (RR 0.35; 95% CI 0.13-0.94; P = 0.047)
- Stoma formation time shorter with unsutured technique (median 24 vs 31 min); specific statistic not fully captured in the abstract
- No apparent differences in other stoma-related or reversal outcomes
Clinical relevance
This single-center trial suggests the unsutured approach may lower parastomal hernia risk, though the multicomponent intervention prevents identifying which element drives the effect.
Who should care
Limitations
Single-center, open-label, per-protocol analysis, and a multicomponent intervention, as the authors acknowledge.
An unsutured composite ileostomy technique was associated with fewer parastomal hernias in this trial.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
Background
Protective loop ileostomy created at the specimen-extraction site is a minimally invasive option after laparoscopic low anterior resection for rectal cancer. Whether different composite techniques influence parastomal hernia risk remains uncertain.
Methods
This prospective, open-label, single-center randomized controlled trial enrolled patients undergoing laparoscopic low anterior resection for rectal cancer with protective specimen-extraction-site loop ileostomy. Patients were randomized intraoperatively to a sutured composite technique, consisting of fascial/peritoneal fixation without a supporting rod, or an unsutured composite technique, consisting of no fascial/peritoneal fixation, routine supporting rod placement, and creation of a smaller tailored fascial aperture. The primary outcome was parastomal hernia before ileostomy reversal, assessed by standardized clinical examination, routine pre-reversal computed tomography, and intraoperative assessment at reversal.
Results
Of 233 randomized patients, 216 were analyzed per protocol, including 111 in the sutured group and 105 in the unsutured group. Parastomal hernia occurred in 13.5% (15/111) and 4.8% (5/105), respectively (risk ratio 0.35, 95% CI 0.13-0.94; risk difference -8.7%, 95% CI - 16.3 to - 1.2; P = 0.047). Stoma formation time was shorter in the unsutured group (median 24 vs 31 min; Hodges-Lehmann difference - 7.2 min, 95% CI -9.0 to -5.4; P <0.001). Time to first stoma output was earlier in the unsutured group (median 12 vs 15 h; Hodges-Lehmann difference - 3.0 h, 95% CI - 4.7 to - 1.8; P <0.001), although this difference was not associated with shorter hospital stay. Other stoma-related complications, reversal outcomes, and quality of life scores were similar between groups.
Conclusion
The unsutured composite technique was associated with lower parastomal hernia risk and shorter stoma formation time compared with the sutured composite technique, without apparent differences in other stoma-related or reversal outcomes. Because the intervention comprised multiple technical components, the independent effect of each component could not be determined.
Trial registration
The trial was registered at ClinicalTrials.gov (NCT06344923).
DOI
10.1007/s00464-026-13420-1
PMID
42791407
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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