Trial reportTechniques in coloproctology2026
The BioSynIRS trial: biologic versus synthetic mesh for multicompartment pelvic floor reconstruction.
Trial report in Techniques in coloproctology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06245577 (Prospective Randomized Pilot Study on the Use of Biological Mesh Versus Synthetic Mesh in Interdisciplinary Resection Rectopexy With Sacro Colpopexy), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective Randomized Pilot Study on the Use of Biological Mesh Versus Synthetic Mesh in Interdisciplinary Resection Rectopexy With Sacro Colpopexy
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSelected patients with obstructed defecation syndrome (ODS) and concomitant pelvic organ prolapse (POP) may require laparoscopic resection rectopexy (L-RRP) with laparoscopic sacrocolpopexy (L-SCP). This trial compared the safety and efficacy of biologic versus synthetic mesh (BM or SM) in L-SCP.
methodsIn this single-center randomized pilot trial, 30 women with severe ODS underwent combined L-RRP and L-SCP using either a BM or SM. The primary endpoint was the severe adverse event rate. Secondary endpoints included functional and anatomical outcomes related to ODS and POP. Follow-up was complete at 12 months for all patients.
resultsThe 30 patients (15 per group) had similar baseline characteristics, comparable frequency of additional surgical procedures, longer operative time in the SM group, lower pain in the BM group, similar length of hospital stay, comparable adverse event rates, and no mesh-related complications. Severe adverse events were reported by two patients (13%) in the BM group versus five (33%) in the SM group. Functional outcomes and POP-Q scores significantly improved in both groups (p < 0.01), urinary incontinence was unchanged, and there were three cases of ODS recurrence at 12 months. The main limitation of this study is its pilot design with a limited sample size and short follow-up, precluding definitive conclusions regarding long-term durability and rare adverse events.
conclusionsNo significant differences in safety were detected between biologic and synthetic mesh; functional and anatomical outcomes improved similarly. Given the pilot design and limited sample size, these findings support the feasibility, but not equivalence or non-inferiority, of the biologic mesh. Adequately powered trials are required to confirm these findings and to evaluate the long-term durability of the biologic mesh.
trial registrationTrial registration at ClinicalTrials.gov (NCT06245577) and at the German Clinical Trials Register (DRKS00033079).
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.