Trial reportInternational journal of colorectal disease2020
Conservative Sinusectomy vs. excision and primary off-midline closure for pilonidal disease: a randomized controlled trial.
Trial report in International journal of colorectal disease, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03271996 (Two Surgical Techniques for the Treatment of Pilinidal Sinus), which is not on this map. Cited by 1 paper.
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.
Two Surgical Techniques for the Treatment of Pilinidal Sinus: A Randomized Controlled Trial
Who cites it
1 citing paper in PubMed, 8 citations in OpenAlex.
- Consensus statement of the Italian society of colorectal surgery (SICCR): management and treatment of pilonidal disease.Techniques in coloproctology · 2021Article
Corrections and comments
- Erratum issued
Authors and funding
8 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposePilonidal sinus disease (PD) is a common acquired disease, responsible for discomfort and time off work. There is currently no consensus on the best surgical therapy. We aimed at comparing conservative sinusectomy (S) to excision and paramedian primary closure (PC).
methodsThis is a randomized controlled trial compatible with the CONSORT statement standards. We included all patients with chronic PD between 2012 and 2017. We excluded patients with acute abscesses, recurrent PD after surgery with a curative intent and patients needing complex reconstructions with rotation flaps. Patients with chronic symptomatic PD were randomized to S or PC. Primary end-point was the rate of patients healed at 3 weeks, secondary outcomes were total healing time, pain, time off work, patient satisfaction and recurrence at 1 year. Patients were seen at a wound clinic until healed and contacted at 3, 6, and 12 months for follow-up.
resultsAfter inclusion of 58 patients the study was stopped prematurely due to discrepancy between expected and observed outcomes. Only 4/30 (13.3%) patients in the S group had healed completely at 3 weeks compared with 14/28 (50%) in the PC group (p = 0.01). Median time to complete healing was 54 (23-328) days in the S group compared to 34 (13-141) in the PC group (p = 0.025). Number of outpatient visits, time off work, analgesia requirement, and recurrence rates at 12 months 4 (16%) in the S group and 3 (11.1%) in the PC group (p = 0.548) were similar.
conclusionsPC leads to faster healing compared to S, with similar healthcare burden.
trial registrationThe study was approved by the local ethics committee and registered in www.clinicaltrials.gov (REF: NCT03271996). The study was carried out at the Regional Hospital of Lugano, Switzerland.
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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 OpenQuestion graph.