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Prospective, randomized, comparative study of Misgav Ladach versus traditional cesarean section at Nazareth Hospital, Kenya

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Abstract

Cesarean section (CS) is the commonest major operation carried out in many low income countries. A new technique for CS, called the Misgav Ladach procedure, was evaluated in a randomized trial in Nazareth Hospital (Kiambu District, Kenya). A total of 160 patients were assigned to the Misgav Ladach procedure (n=80) or to the traditional CS as performed in most rural hospitals in low income countries (n=80). The two groups were analyzed by operating time, presence of infection and febrile morbidity, grade of postoperative pain, starting of fluid and solid alimentation, and development of incisional hernia and hypertrophic scar. The operating time of the Misgav Ladach procedure was significantly shorter. 20.4 (SD 6.1) minutes versus 30.4 (SD 6.1) minutes (p< 0.001). A total of 5 wound infections (6.2%) were seen with the Misgav Ladach procedure versus 16 (20.0%) in the control group (p=0.01). The number of analgesic doses required during the postoperative period were significantly less in the Misgav Ladach group: 1.3 (SD 0.6) versus 1.9 (SD 0.7) ampuls of pethidine (p<0.001) and 15.1 (SD 2.0) versus 16.4 (SD 1.8) tablets of ibuprofen (p<0.001). Incisional pain was significantly less in the Misgav Ladach group: Visual Analogue Scale score 3.0 (SD 1.5) versus 4.9 (SD 2.0),p<0.01. The patients in the Misgav Ladach group began drinking fluids voluntarily [19.1 (SD 4.5) hours versus 20.6 (SD 4.0) hours;p=0.01] and eating solid food [41.2 (SD 9.3) hours versus 46.1 (SD 9.0) hours;p<0.01] significantly before than those in the control group. At the 6-week follow-up, the presence of hypertrophic scar was significantly associated with the traditional procedure (2.1% vs. 48.8%;p<0.001). We conclude that the Misgav Ladach operation should become the standard method for performing CS in low income countries, particularly in rural hospitals.

Résumé

La césarienne (CS) est l’intervention majeure la plus fréquemment réalisée dans beaucoup de paysà basse économie. Pour évaluer une nouvelle technique de césarienne, appelé le procédé de «Misgav Ladach», dans une étude randomiséeà l’hôpital Nazareth Hospital (Kiambu District, Kenya), 160 patientes ont été allouées soit au procédé de «Misgav Ladach» (n=80) soità la césarienne traditionnelle CS (n=80), comme réalisée dans la plus grande majorité des hôpitaux ruraux dans les paysà revenu peu élevé. On a analysé la durée de l’opération, la présence d’infection et la morbidité hyperthermique, le degré de la douleur postopératoire, le début de l’alimentation liquidienne et solide, le développement d’une éventration, et la survenue d’une cicatrice hypertrophique. La durée opératoire pour le procédé de «Misgav Ladach» a été significativement plus courte (20.4 (SD=6.1) versus 30.4 (SD=6.1) minutes (p<0.001)). On a noté cinq cas d’infection pariétale (6,2%) dans la technique de Misgav Ladach comparésà 16 cas (20.0%) dans le groupe contrôle (p=0.01). Les patientes dans le groupe Misgav Ladach ont eu besoin de moins de doses d’analgésiques dans la période postopératoire: 1.3 (SD=0.6) versus 1.9 (SD=0.7) ampoules de Péthidine (p<0.001) et 15.1 (SD=2.0) versus 16.4 (SD=1.8) compresses d’ibuprofène (p<0.001). La douleur au niveau de la cicatrice était significativement moindre dans le groupe «Misgav Ladach» avec un scoreà l’échelle visuelle analogue de 3,0 (SD=1.5) versus 4,9 (SD=2.0), p<0.01. De plus, les patients dans le groupe «Misgav Ladach» ont commencéà boire des liquides (19.1, SD=4.5, versus 20.6, SD=4.0 heures, p=0.01) et a mangé des aliments solides (41.2, SD=9.3, versus 46.1, SD=9.0 heures, p<0.01) plus tôt que celles du group de contrôle. A six semaines, il y avait plus de femmes qui avaient une cicatrice hypertrophique dans le groupe de césarienne classique (2.1% versus 48.8%, p<0.001). Nous concluons que le procédé de «Misgav Ladach» devrait être la méthode de référence pour césarienne dans les paysà revenue bas, surtout dans les hôpitaux ruraux.

Resumen

La operación de cesárea (CS) es la intervención más frecuente en paises subdesarrollados. Con objeto evaluar una nueva técnica de CS, denominada Misgaw Ladach, se efectuó un estudio randomizado en el Hospital de Nazareth (distrito de Kiambu, Kenya). Se recopilaron 160 pacientes en las que se realizó la técnica de Misgaw Ladach (n=80) o la CS convencional, como se realiza en la mayoria de los hospitales rurales en los paises en vias de desarrollo (n=80). Ambos grupos se analizaron para valorar el tiempo operatorio, la infección y la morbilidad febril, el grado de dolor postoperatorio, el momento en que se comenzó la ingesta liquida y sólida, el desarrollo de eventraciones y de cicatrización queloidea. El tiempo operatorio con la técnica de Misgaw Ladach es significativamente más cortö 20.4 (SD=6.1) vs 30.4 (SD=6.1) minutos (p<0.001). Con la técnica de Misgaw Ladach se observaron 5 infecciones de la herida operatoria (6.2%) frente a 16 (20%) en el grupo control (p=0.01). El número de dosis analgésicas requeridas por las operadas con la técnica de Misgaw Ladach fue significativamente menor: 1.3 (SD=0.6) vs 1.9 (SD=0.7) ampollas de petidina (p<0.001) y 15.1 (SD=2.0) vs 16.4 (SD=1.8) apósitos de Ibuprofen (p<0.001). El dolor de la herida operatoria fue significativamente menor con la técnica de Misgaw Ladach: En la escala analógica visual alcanzó un grado de 3.0 (SD=1.5) vs 4.9 (SD=2.0), (p<0.01). Además, las pacientes operadas con la técnica de Misgaw Ladach empezaron voluntariamente a beber (19.1, SD=4.5 vs 20.6 SD=4.0 horas, p=0.01) y a ingerir alimentos sólidos (41.2 SD=9.3 vs 46.1 SD=9.0 horas, p<0.01), mucho antes que las del grupo control. Tras un seguimiento de 6 semanas se observaron cicatrices queloideas en el 2.1% de las intervenciones realizadas con la técnica de Misgaw Ladach frente a un 48.8% de las operadas de cesárea con la técnica tradicional (p<0.001). Concluimos senãlando que la técnica de Misgaw Ladach CS debe convertirse en el método estándar para la realización de una cesárea en pueblos económicamente débiles y, especialmente en los hospitales rurales.

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Ansaloni, L., Brundisini, R., Morino, G. et al. Prospective, randomized, comparative study of Misgav Ladach versus traditional cesarean section at Nazareth Hospital, Kenya. World J. Surg. 25, 1164–1172 (2001). https://doi.org/10.1007/BF03215866

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