The Rule of 10s for Cleft Repair: A Historical Review of the Literature

Abstract

Background: Cleft lip is a ubiquitous maxillofacial birth defect encountered globally. Repair of this anomaly has been well established in the literature. Historically, studies have recommended initiating surgical repair by the “Rule of 10s.” This states that a baby should be at least 10 weeks of age or older, achieve a weight of 10 pounds, have a hemoglobin exceeding 10 g/dL, and have a white blood cell count <10,000/mm3 before undergoing surgery. However, with advances in both pediatric anesthesia and surgical technique, the concept of prioritizing earlier surgery requires a closer examination of this widespread concept. Objective: The aim of this study was to assess the validity of the Rule of 10s for cleft lip repair and to determine whether plastic surgeons should continue to follow this as a strict rule or employ it as a guideline. Methods: A literature search was conducted by G.S., and reviewed by J.L. and M.K. All studies that addressed the “Rule of 10s” for cleft lip patients were considered. Articles were chosen from a comprehensive set of databases, including EMBASE, MEDLINE, and Cochrane Central Register of Controlled Trials databases in March 2022. A literature search was conducted using the following keywords: rule of 10s, Millard criteria, cleft lip/palate, cleft lip/palate repair, and cleft lip/palate complications. Reference lists of selected studies were reviewed for other appropriate publications. Meta-analyses, prospective, randomized clinical trials, retrospective reviews, letters, and literature reviews were included. Single case reports, non-English publications, animal studies, and comments were excluded. Results: Among the studies included in this review, the authors found that the Rule of 10s has undergone a limited evaluation within the context of today’s advances in surgical technique and anesthesia. The current articles generally conclude surgeons may proceed with earlier cleft repair on otherwise healthy infants who do not meet all criteria of the Rule of 10s. Conclusions: When taking into consideration the current advances in surgical technique and diminished risks of anesthesia, the Rule of 10s should be applied only as a guideline instead of a rule in plastic surgery. Surgeons should address each patient individually and adhere more rigidly to the Rule of 10s when the infant does not have characteristics warranting expedited repair.