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The Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 11. What next?
J Plast Surg Hand Surg. 2017 Feb; 51(1):88-93.JP

Abstract

BACKGROUND AND AIMS

Longstanding uncertainty surrounds the selection of surgical protocols for unilateral cleft lip and palate (UCLP), and randomised trials have only occasionally been performed. The Scandcleft Project consists of three trials initiated in 1997. The results at age 5 have been published in the series of reports that precede this manuscript, which aims to distill some of the issues that future trialists may need to address.

METHOD

The shared experience of this group of trials is reviewed with reference to the current literature on trial management and, more specifically, trials of surgical technique and timing.

RESULTS

The main discussion points relate to the challenges associated with research bureaucracy, learning curve, individuality of skill, and ethics.

CONCLUSIONS

Compliance with current regulatory requirements for clinical trials and recruitment rates for cleft sub-types represent substantial challenges. Mastery of new surgical techniques prior to trials raises important ethical issues, although recent reports in the wider surgical literature suggest that learning may be hastened with the assistance of anonymised peer review ratings of intraoperative performance. The three Scandcleft Trials succeeded in meeting the planned recruitment targets, and completed follow-up with remarkably high retention rates (99.3%). The design of the study required the majority of participating surgeons to master a new technique and, although overall outcomes were comparable with those in the literature, the associated learning curve increased postoperative complications in two of the trials.

TRIAL REGISTRATION

ISRCTN29932826.

Authors+Show Affiliations

a School of Dentistry , University of Manchester , Manchester , UK.a School of Dentistry , University of Manchester , Manchester , UK. b Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.

Pub Type(s)

Journal Article
Multicenter Study
Review

Language

eng

PubMed ID

28218554

Citation

Shaw, William, and Gunvor Semb. "The Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate: 11. what Next?" Journal of Plastic Surgery and Hand Surgery, vol. 51, no. 1, 2017, pp. 88-93.
Shaw W, Semb G. The Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 11. What next? J Plast Surg Hand Surg. 2017;51(1):88-93.
Shaw, W., & Semb, G. (2017). The Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 11. What next? Journal of Plastic Surgery and Hand Surgery, 51(1), 88-93. https://doi.org/10.1080/2000656X.2016.1254644
Shaw W, Semb G. The Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate: 11. what Next. J Plast Surg Hand Surg. 2017;51(1):88-93. PubMed PMID: 28218554.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 11. What next? AU - Shaw,William, AU - Semb,Gunvor, PY - 2017/2/21/entrez PY - 2017/2/22/pubmed PY - 2017/12/16/medline KW - Randomised controlled trials KW - Scandcleft KW - learning curve KW - multicentre study KW - skill KW - unilateral cleft lip and palate surgery SP - 88 EP - 93 JF - Journal of plastic surgery and hand surgery JO - J Plast Surg Hand Surg VL - 51 IS - 1 N2 - BACKGROUND AND AIMS: Longstanding uncertainty surrounds the selection of surgical protocols for unilateral cleft lip and palate (UCLP), and randomised trials have only occasionally been performed. The Scandcleft Project consists of three trials initiated in 1997. The results at age 5 have been published in the series of reports that precede this manuscript, which aims to distill some of the issues that future trialists may need to address. METHOD: The shared experience of this group of trials is reviewed with reference to the current literature on trial management and, more specifically, trials of surgical technique and timing. RESULTS: The main discussion points relate to the challenges associated with research bureaucracy, learning curve, individuality of skill, and ethics. CONCLUSIONS: Compliance with current regulatory requirements for clinical trials and recruitment rates for cleft sub-types represent substantial challenges. Mastery of new surgical techniques prior to trials raises important ethical issues, although recent reports in the wider surgical literature suggest that learning may be hastened with the assistance of anonymised peer review ratings of intraoperative performance. The three Scandcleft Trials succeeded in meeting the planned recruitment targets, and completed follow-up with remarkably high retention rates (99.3%). The design of the study required the majority of participating surgeons to master a new technique and, although overall outcomes were comparable with those in the literature, the associated learning curve increased postoperative complications in two of the trials. TRIAL REGISTRATION: ISRCTN29932826. SN - 2000-6764 UR - https://www.unboundmedicine.com/medline/citation/28218554/The_Scandcleft_randomised_trials_of_primary_surgery_for_unilateral_cleft_lip_and_palate:_11__What_next L2 - http://www.tandfonline.com/doi/full/10.1080/2000656X.2016.1254644 DB - PRIME DP - Unbound Medicine ER -