Table 4.
Clinical studies reporting possible implications for surgical techniques used in cleft palate repair in relation to otological outcome
| Authors | Year | Aim of the study | Study type | No. of subjects | Mean age | Results | Conclusions |
|---|---|---|---|---|---|---|---|
| Sehhati-Chafai-Leuwer et al. [3] | 2006 | Evaluating otological status and TVP integrity in adult patients with repaired cleft palate usingotomicroscopy and MRI. | Case-control study | N = 15 (1 subject with unrepaired cleft) | 25 years (range 13 – 45) | (1) All patients with repaired cleft and chronic ME pathology (n = 7) showed non-intact TVP (neither towards the LVP nor towards the hamulus) on MRI. Hamulus was undetectable on MRI in 4/7 cases. (2) All patients with repaired cleft palate and normal otomicroscopy findings (n = 7) had intact TVP and hamulus on MRI. (3) The patient with unrepaired cleft showed only mild ear pathology with a complete TVP. |
Evident correlationbetween post-treatmentintegrity of the TVP and ME status, with all patients having an incomplete TVP suffering from middle ear pathology. |
| Flores et al. [21] | 2010 | Comparing effects of TVP preservationa, transectionb, and “tensor tenopexy”c on ET function. | Case-control study | N = 147 TVP preservation (n = 64) vs. TVP transection (n = 31) vs. tensor tenopexy (n = 52) | Subjects followed from age 1–7 years | (1) Decreased need ventilation tube insertion from age >4 years in the tenopexy group compared with the transection group. (2) Decreased need for ventilation tube insertion in the tenopexy group compared with the tensor preservation group (significant at age 4-5 years). (3) Decreased need for ventilation tube insertion in the tensor preservation group compared with the transection group (significant at age 6-7 years). |
(1) Tensor preservation and tensor tenopexy significantly improve ME status compared to tensor transection. (2) Tension tenopexy seems to have the most beneficial effects on ME status. |
| Tiwari et al. [38] | 2013 | Evaluating the effects of tensor tenopexy on ET function and preventing hearing loss. | Randomized controlled trial | N = 17 tensor tenotomy (n = 8) vs. tensor tenotomy with tenopexy (n = 9) | NR (range: 9–24 months) |
No significant difference in hearing loss and middle ear effusion between both groups at follow-up of 3, 6, 9 and 12 months. | Tenopexy was not found to be helpful in maintaining ET function or preventing hearing loss under the age of 12 months. |
| Bütow et al. [39] | 1991 | Evaluating the effects of TVP tension slingd on ME status. | Case-control study | N = 39 tension sling (n = 19) vs. controls without sling (n = 20) | NR (range 6 – 36 months) |
(1) ME status of the controls after surgery is not significant improved compared to ME status of the cases prior surgery. (2) ME status of the tension sling cases significantly improved at 9 and 18 months after surgery compared to the control group. |
TVP tension sling seems to have beneficial effects on ME status. |
| Kane et al. [40] | 2000 | Examining the effect of hamulus fracture on outcome of palatoplasty in cleft palate patients | Randomized controlled trial | N = 161 hamulus fracture (n = 85) vs. no hamulus fracture (n = 76) | 25 months (range: NR) |
No significant difference in oral mucosa dehiscence rate and fistula occurrence between both groups. | Hamular fracturing during palatoplasty does not affect the occurrence of complications. |
MRI magnetic resonance imaging, TVP tensor veli palatini muscle, ME middle ear, ET Eustachian tube
aTVP preservation—cleft palate repair with construction of the levator sling (no damage to the TVP or its tendon)
bTensor transection—TVP tendon transection and levator sling construction
cTensor tenopexy—surgical technique involving isolation of the TVP, medially displacement of the TVP tendon, suturing the tendon under tension to the hamulus, transecting the tendon medially from the hamulus, and construction of the levator sling
dTVP tension sling—procedure during cleft palate surgery during which a suture sling is inserted around the tendon of the TVP medial to the hamulus at one side, then wrapping it around the tendon of the TVP at the other side followed by tying the ends together under maximal tension