STARR with CONTOUR® TRANSTAR™ device for obstructed defecation syndrome: one-year real-world outcomes of the European TRANSTAR registry

Abstract

Purpose: Stapled transanal rectal resection (STARR) in patients with obstructive defecation syndrome (ODS) is limited by the capacity of the circular stapler used. This prospective cohort study was conducted to assess real-world clinical outcomes of STARR with the new CONTOUR® TRANSTAR™ device, shortly named TRANSTAR, at 12 months postoperatively.

Methods: From January 2009 to January 2011, consecutive patients who underwent TRANSTAR in 22 European colorectal centers were enrolled in the study. Functional outcomes and quality of life were assessed by the changes in a number of scoring systems (Knowles-Eccersley-Scott-Symptom (KESS) score, ODS score, St. Mark's score, Euro Quality of Life-5 Dimension (EQ-5D) score, and Patient Assessment of Constipation-Quality of Life (PAC-QoL) score), at 12 months as compared to baseline. All complications were recorded and analyzed.

Results: A total of 100 patients (98% female), mean age 60 years, were entered in the study. Statistically significant improvements were seen in the KESS (median 18 vs. 6; p < 0.01), ODS (median 15 vs. 4; p < 0.01), and PAC-Qol scores (median 2.10 vs. 0.86; p < 0.01). St. Mark's and EQ-5D scores improved nonsignificantly. Complications were reported in 11 % of patients, including bleeding (5%), staple line complications (3%), urinary retention (2%), and persistent pain (1%). No major complications or mortality occurred.

Conclusion: TRANSTAR facilitated a tailored, real circumferential full-thickness rectal resection, leading to improved patient functional and quality of life outcomes at 12 months postoperatively. It represents a safe and effective treatment for ODS in local clinical practice, although the sustainability of real-world results needs to be proven in the long-term follow-up.

Fig. 1

Comparisons of study scores mean values at baseline and 12 months postoperatively. Statistically significant improvements were observed in the KESS, ODS, and PAC-QoL scores at 12 months as compared with baseline (*Wilcoxon signed ranks test and paired samples t test, both P < 0.01)

Fig. 2

Comparisons of study scores median values at baseline and 12 months postoperatively. Statistically significant improvements were observed in the KESS, ODS, and PAC-QoL scores at 12 months as compared with baseline (*Wilcoxon signed ranks test and paired samples t test, both P < 0.01)

Fig. 3

Odds ratio (OR) for ODS calculated from KESS score assuming the preoperative symptoms would remain unchanged in an untreated control group. TRANSTAR significantly reduce the risk of ODS by ten times (OR = 10.6) at 12 months postoperatively, when a median of ≥10 for KESS score was used as a cut-off criterion between constipated and non-constipated groups

Fig. 4

Odds ratio (OR) for fecal incontinence, pain, and urgency calculated from KESS score and St. Marks score assuming the preoperative symptoms would remain unchanged in an untreated control group. TRANSTAR significantly reduce the risk of fecal incontinence (OR = 0.30) and abdominal pain (OR = 0.32) and nonsignificantly increase the risk of urgency (OR = 1.15) at 12 months postoperatively